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Author Topic: Deep brain stimulator - Electrodes  (Read 77735 times)
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dennis100
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« on: November 06, 2013, 12:47:32 AM »

Model Number UNKNOWN
Device Problems High impedance; Low impedance
Event Date 06/17/2010
Event Type  Malfunction  
Event Description

The deep brain stimulator battery underwent rapid battery depletion. It was replaced (reference mfg. Report # 3004209178201005511). Troubleshooting with the replacement deep brain stimulator revealed impedances less than 50 ohms on bipolar electrode pair 0-2. The device delivered therapy using electrodes 0-2. Impedances readings greater than 2000 ohms were also reported. The battery measurement had changed from 3. 72 to 3. 67 (usage dates not reported). Additional information has been requested. A follow-up report will be submitted if additional information becomes available.
 
Manufacturer Narrative

(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1761201
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« Reply #1 on: November 06, 2013, 12:48:03 AM »

Model Number IPGNEURO
Device Problems Device operational issue; Impedance issue
Event Date 07/13/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

Received info reporting intermittent stimulation. Kinetra system had been implanted for more than 6 months when the pt noticed therapy on the left side of the body was not okay. The neurologist changed the programming and the pt would leave the clinic okay and one week or a couple days later, the pt would have the same complaint, loss of therapy on the left side. Impedances were checked but the neurologist was not confident in the values. The pt was operated on to change the extension cable that connects the kinetra to the right side dbs electrode. To rule out malfunctioning of the kinetra, physicians switched the left channel with the right channel of the stimulator. Pt was oaky after this procedure but later, the therapy loss occurred again. X-rays, ct scan and impedance readings were all fine. It was decided to change the dbs electrode. After replacing the lead intra-op stimulation with the kinetra reconnected to the lead showed normal impedances values. The pt left the operating room with therapy on and effective. The explanted lead had no visible damage. Pt was reported as okay.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1901993
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« Reply #2 on: November 06, 2013, 12:48:22 AM »

Model Number IPGNEURO
Device Problem Improper or incorrect procedure or method
Event Date 12/29/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. The patient information provided is the average for all the patients. At this time, no additional information was available, additional information regarding device, the event and patient outcome has been requested.
 
Event Description

Literature: holl em, petersen ea, foltynie t, et al. Improving targeting in image-guided frame-based deep brain stimulation. Neurosurgery. December 2010; 67(2 suppl operative):437-447. Summary: pre- and postoperative stereotactic magnetic resonance images (mri) were analyzed in 165 patients with parkinson disease (pd). The perpendicular error between planned target coordinates and electrode trajectory was calculated geometrically for all 312 dbs electrodes implanted. Improvement in motor unified pd rating scale iii subscore was calculated for those patients with pd with at least 6 months of follow-up after bilateral subthalamic dbs. Reportable event: in one patient undergoing bilateral pallidal dbs under general anesthesia, stereotactic mri revealed a medial deviation of the left electrode from the intended anatomic target with encroachment on the internal capsule. Immediate relocation of this electrode was performed followed by a new postoperative stereotactic mri.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1995930
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« Reply #3 on: November 06, 2013, 12:48:43 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 12/29/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. The pt info provided is the average for all the pts. At this time no add'l info was available, add'l info regarding the device, the event and pt outcome has been requested.
 
Event Description

Literature: holl em, peterson ea, foltynie t, et al. Improving targeting in image-guided frame-based deep brain stimulation. Neurosurgery. Dec 2010; 67 (2 suppl operative): 437-447. Summary: pre- and postoperative stereotactic magnetic resonance images (mri) were analyzed in 165 pts with parkinson disease (pd). The perpendicular error between planned target coordinates and electrode trajectory was calculated geometrically for all 312 dbs electrodes implanted. Improvement in motor unified pd rating scale iii subscore was calculated for those pts with pd with at least 6 months of f/u after bilateral subthalamic dbs. Reportable event: delayed relocation of the right electrode was performed in one pt (pt 1 of 2) with bilateral pallidal dbs owing to suboptimal clinical response and anatomic location. Repeat postoperative stereotactic imaging was performed after electrode relocation, allowing calculation of the targeting error for the relocated electrode trajectory. See literature article with mfr report # 3007566237201101161.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000244
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« Reply #4 on: November 06, 2013, 12:49:04 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 12/29/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: holl em, peterson ea, foltynie t, et al. Improving targeting in image-guided frame-based deep brain stimulation. Neurosurgery. Dec 2010; 67 (2 suppl operative): 437-447. Summary: pre- and postoperative stereotactic magnetic resonance images (mri) were analyzed in 165 pts with parkinson disease (pd). The perpendicular error between planned target coordinates and electrode trajectory was calculated geometrically for all 312 dbs electrodes implanted. Improvement in motor unified pd rating scale iii subscore was calculated for those pts with pd with at least 6 months of f/u after bilateral subthalamic dbs. Reportable event: one pt (pt 2 of 2) with bilateral stn dbs electrodes underwent delayed repositioning of the left electrode to a more posterolateral location after he experienced gradual deterioration in stimulation efficacy and in speech articulation. See literature article with mfr report# 3007566237201101161.
 
Manufacturer Narrative

(b)(4) - deterioration in speech articulation. It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. The pt info provided in section a is the average for all the pts. At this time no add'l info was available, add'l info regarding the device, the event and pt outcome has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000249

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« Reply #5 on: November 06, 2013, 12:49:29 AM »

Model Number IPGNEURO
Device Problem Low impedance
Event Date 02/01/2011
Event Type  Malfunction  
Event Description

It was reported, the patient's device was showing low impedance readings. After the implant of the patient's device, impedances were checked and it was found that case and #10, and case and #11 electrodes had impedances of 700 ohms, and electrodes 10 and 11 had an impedance check of 34 ohms. No patient symptoms were reported. Additional information has been requested, a follow-up report will be sent if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2030182


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« Reply #6 on: November 06, 2013, 12:49:56 AM »

Model Number IPGNEURO
Device Problems Fracture; No Information
Event Date 03/08/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: moro e, lozano am, pollak p, et al. Long-term results of a multicenter study on subthalamic and pallidal stimulation in parkinson's disease. Mov disord. 04/15/2010;25(5):578-586. Summary: this article reported the 5 to 6 year follow-up of a (b)(4) study of bilateral subthalamic nucleus (stn) and globus pallidus internus (gpi) deep brain stimulation (dbs) in advanced parkinson's disease (pd) patients. Thirty-five stn patients and 16 gpi patients were assessed at 5 to 6 years after dbs surgery. Primary outcome measure was the stimulation effect on the motor unified parkinson's disease rating scale (updrs) assessed with a prospective cross-over double-blind assessment without medications (stimulation was turned on and off randomly). Secondary outcomes were motor updrs changes with unblinded assessments in off- and on- medication states, with and without stimulation, activities of daily living, anti-pd medications, and dyskinesias. The patients had been implanted with bilateral gpi- or stn-dbs between (b)(6) 1996 and (b)(6) 1998 and also had been assessed at a 3-4 year follow-up, the results of which have been reported elsewhere. Reportable events: one gpi-dbs patient underwent surgery for a lead fracture. One gpi-dbs patient who lost dbs motor benefit between the 3-4 year evaluation and the 5-6 year follow-up underwent successful bilateral stn-dbs. It was hypothesized that the loss might have been due to suboptimal placement of the electrode inside the pallidum. One gpi-dbs patient had the leads and ipg's explanted and not replaced between the 3-4 year evaluation and the 5-6 year follow-up. No other information was provided. One stn-dbs patient had the ipg explanted prior to the 3-4 year follow-up. No other information was provided. Two patients with stn-dbs underwent lead replacements. No other information was provided. One patient with stn-dbs underwent replacement of the ipg and extension. No other information was provided.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. It is also possible several events occurred in one patient. At this time no additional information was available, additional information regarding the patient, event, interventions and outcome has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107174

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« Reply #7 on: November 06, 2013, 12:50:18 AM »

Model Number IPGNEURO
Device Problem No Information
Event Date 04/03/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the patient initially had "excellent response" to their deep brain stimulator after placement. In (b)(6) 2006, it was stated the patient had problems with "hallucinations and vivid dreams. " in (b)(6) 2007, testing showed a decline in the patient's cognitive function "consistent with mild dementia. " on (b)(6) 2007, the patient had their electrodes replaced as it was felt that their initial placement may have been suboptimal. It was not clear the revised electrode placement had any beneficial effect. No further follow up is possible regarding this patient.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2276356

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« Reply #8 on: November 06, 2013, 12:50:59 AM »

Event Date 03/30/2012
Event Type  Malfunction  
Manufacturer Narrative

Product id 3389-28, serial# unknown, implanted: 2012-(b)(6), product typ lead. (b)(4).
 
Event Description

It was reported that the blue torque wrench clicked too late. The proximal contact of the electrode connection was damaged and unusable. Additional information received reported the event happened at the end of the lead implant procedure. The surgeon noticed the contact damage at the time the implantable neurostimulator (ins) was implanted a few days after the lead implant. The physician left the lead implanted and used the other contacts to achieve satisfying stimulation. There was no patient injury and the patient was fine.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2556539
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« Reply #9 on: November 06, 2013, 12:51:21 AM »

Model Number SC 37603
Event Date 09/01/2013
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

On (b)(6) 2013, programming elicited unusual impedence on leads 2 and 3. Concern for short in lead. Skull x-ray ordered. On (b)(6) 2013, mom called to report small nodule behind left ear near dbs wire. No redness or swelling, but is tender. Had exploration (b)(6) 2013, at connection site for electrode and extension wire. Intraoperatively confirmed short in electrode, there was a blackened area 2 cm superior to connection in right dbs electrode. Ipg also at end of service due to short. Had surgery (b)(6) 2013, to successfully replace the right electrode and right ipg (soletra). At completion of surgery, all impedances were normal.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3354500

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« Reply #10 on: November 06, 2013, 12:51:52 AM »

Device Problem High impedance
Event Date 01/17/2011
Event Type  Malfunction  
Event Description

High impedances were noted on a lead; it was replaced (reference mfg report # 3007566237-2010-10539). Post operative impedances were normal on the replacement lead. However, the distal electrode shows high impedances now. The implantable neurostimulator was reprogrammed to deliver therapy with a different electrode. There was no pt injury. The pt is ok. Add'l info has been requested. A f/u report will be submitted if add'l info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2087922
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« Reply #11 on: November 06, 2013, 12:52:13 AM »

Model Number IPGNEURO
Device Problem Device operates differently than expected
Event Date 01/01/2011
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the pt never experienced therapeutic effects on the "second side. " reprogramming had not been successful. The pt acquired a second opinion and was told the lead was "too deep. " three of the 4 electrodes were non-functional. Further info reported that immediately following left side implant, the pt experienced severe pain and headache. The headaches continued in the weeks prior to implantation of the neurostimulator. After the neurostimulator was implanted, three of the 4 terminals or cases did not seem to be operating, and it was thought that the pt's brain may have had some swelling which was expected to recede in a "few weeks. " after a scan, the pt was told the device "placement was perfect. " the pt's speech continued to deteriorate. Multiple reprogramming sessions had resulted in the same symptoms: slurred speech, little to no tremor relief, and occasionally facial pulling. A second physician informed the pt the device was "too deep in his thalamus and that it would never work properly" or that the device may be malfunctioning. The physician informed the pt that the first three cases could not be used because they were "through the area they needed to be in and because of that placement-could only have adverse affects. " the physician recommended a replacement of the neurostimulator. The pt left the appointment with his device turned off. The pt received a letter from his physician on (b)(6) 2011 stating that the lead placement was correct and that the pt was being released from care. Post-operative mris showed lead were directly parallel and 11. 5mm from the mid-line in the std. Impedances were within normal limits. Additional info has been requested but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2219647
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« Reply #12 on: November 06, 2013, 12:52:34 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 08/03/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the patient was implanted with an activa rc on (b)(6) 2011 and everything was ok. The patient came to a consultation in (b)(6) 2011 / (b)(6) 2011 because she didn't feel well. The stimulator and impedances were ok, but the doctor saw an edema around the two electrodes and had a suspicion of infection. The doctor stopped stimulation, but could not confirm an infection. The doctor started a treatment with medrol and the patient seemed to improve, but the activa rc was not restarted. Additional information has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2235006
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« Reply #13 on: November 06, 2013, 12:52:56 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 05/01/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no add'l info was available, add'l info regarding the pt and the device has been requested.
 
Event Description

Literature: kennedy sh, giacobbe p, rizvi sakina j, et. Al. Deep brain stimulation for treatment-resistant depression: follow-up after 3 to 6 years. Am j psychiatry. 2011;168(5):502-510. http://Http://www. Ncbi. Nim. Nih. Gov/pubmed/21285143. Summary: the authors represent an extended f/u of 20 pts with treatment-resistant depression who received deep brain stimulation (dbs) to the subcallosal cingulate fyrus (brodmann¿s area 25) between (b)(6) 2003 and (b)(6) 2006. After an initial (b)(4) study of dbs, pts were seen annually and at a last f/u visit (between (b)(6) and (b)(6) 2009) to assess depression severity functional outcomes, and adverse events. There were 9 male pts and 11 female pts. Functional impairment in the areas of physical health and social functioning progressively improved up to the last f/u visit and in general, pts required less medication after dbs implantation. Reportable event: the authors reported that one pt had a hardware infection in the first 3 months after surgery. This complication was related to technical factors, including externalization of electrodes. The hardware was replaced without complication and with continuing clinical benefit. The source literature did not specify which device model was used. See literature article with mfr report# 3007566237-2011-07025.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2234660

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« Reply #14 on: November 06, 2013, 12:53:16 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Type  Injury  
Event Description

Literature: kennedy sh, giacobbe p, rizvi sakina j, et. Al. Deep brain stimulation for treatment-resistant depression: follow-up after 3 to 6 years. Am j psychiatry. 2011;168(5):502-510. (b)(4). Summary: the authors represent an extended f/u of 20 pts with treatment-resistant depression who received deep brain stimulation (dbs) to the subcallosal cingulate fyrus (b)(6) between (b)(6) 2003 and (b)(6) 2006. After an initial 12 month study of dbs, pts were seen annually and at a last f/u visit (between (b)(6) and (b)(6) 2009) to assess depression severity functional outcomes, and adverse events. There were 9 male pts and 11 female pts. Functional impairment in the areas of physical health and social functioning progressively improved up to the last f/u visit and in general, pts required less medication after dbs implantation. Reportable event: the authors reported that one pt had a hardware infection in the first 3 months after surgery. This complication was related to technical factors, including externalization of electrodes. The hardware was replaced without complication and with continuing clinical benefit. The source literature did not specify which device model was used. See literature article with mfr report# 3007566237-2011-07025.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. The pt info provided is the average for all the pts. At this time no add'l info was available, add'l info regarding the pt and the device has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2234646

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« Reply #15 on: November 06, 2013, 12:53:37 AM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 05/21/2009
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative

(b)(4). The pt info provided is the average for all the pts. At this time, no add'l info was available, add'l info regarding the pts and devices has been requested.
 
Event Description

Literature: smeding hmm, speelman jd, huizenga hm, schuuman pr, schmand b. Predictors of cognitive and psychosocial outcome after stn dbs in parkinson's disease. J neurol neurosurg psychiatry. 2011;82(7):754-760. Doi 10. 1136/jnnp. 2007. 140012. Summary: the authors examined predictors of cognitive decline and quality of life 1 year after bilateral subthalamic nucleus deep brain stimulation (stn dbs) in parkinson's disease (pd). A total of 105 pts were evaluated with a comprehensive neuropsychological assessment before and 12 months after surgery. A control group of 40 pd pts was included to control for effects of repeated testing and disease progression. Reportable event: the authors reported that normative comparisons method revealed that 38 out of the 105 stn pts showed cognitive decline, which is a pattern of test results that deviated significantly and in a negative direction from the control group. One stn pt had a pallidotomy during the f/u interval, two pts had a dislocated electrode, and two pts suffered a postoperative hemorrhage. After 12 months, six pts from the stn group were lost to f/u; two had an infection of the stimulator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2246529


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« Reply #16 on: November 06, 2013, 12:54:01 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/22/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: foltyinie t, zrinzo l, martinez-torres i, et al. Mri-guided stn dbs in parkinson's disease without microelectrode recording: efficacy and safety. J neurol neurosurg psychiatry. Apr 2011; 82(4): 358-363. Summary: this series describes the outcomes of 79 consecutive pts that underwent bilateral stn dbs at the national hosp for neurology and neurosurgery between (b)(6) 2002 and (b)(6) 2008 using an mri-guided surgical technique without microelectrode recording. Pts showed significant improvements in dyskinesia duration, disability and pain, with a mean reduction in on-medication dyskinesia severity from 3. 15 pre-operatively to 1. 56 post-operatively. Quality of life improved by a mean of 5. 5 points on the parkinson's disease index. This series confirms that image-guided stn dbs without microelectrode recording can lead to substantial improvements in motor disability of well selected pd pts with accompanying improvements in quality of life and with very low morbidity. Reportable event: the pt underwent further surgery for their parkinson's disease due to insufficient response from the first operation. One of the two stn electrodes was re-positioning with improvement in clinical effect. See literature article attached to mfr report # 3007566237201107448.
 
Manufacturer Narrative

(b)(4). Average for entire population used to complete this section.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2246567
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« Reply #17 on: November 06, 2013, 12:54:24 AM »

Model Number IPGNEURO
Device Problem Bent
Event Date 01/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

The electrode tip was curved. It was explanted. Add'l info has been requested. A f/u report will be submitted if add'l info becomes available.
 
Manufacturer Narrative

(b) (4). The lead was returned to the mfr for analysis which is not complete as of the date of this report. A f/u report will be sent when the analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1676369
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« Reply #18 on: November 06, 2013, 12:54:45 AM »

Model Number IPGNEURO
Device Problem Positioning Issue
Event Date 05/04/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time, no additional info was available, additional info has been requested.
 
Event Description

Literature: capelle hh, blahak c, schrader c, et al. Chronic deep brain stimulation in pts with tardive dystonia without a history of major psychosis. Mov disord. Jul 30 2010; 25(10):1477-1481. Summary: four women with tardive dystonia (secondary to neuroleptic medication) without a history of major psychosis underwent bilateral pallidal dbs in this observational study. Their tardive dystonia occurred more than 6 months after exposure to the neuroleptic medication. All pts had preoperative mr scans; all experienced sustained statistically significant benefit from pallidal dbs and there were no surgically related complications. Reportable event: pt 4 had unilateral stimulation; the electrode on the other side was not activated as it had been misplaced. As unilateral stimulation did not result in sustained improvement over the years, the pt was scheduled for revision of the misplaced electrode and then enrolled in this study.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1879532
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« Reply #19 on: November 06, 2013, 12:55:08 AM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 12/16/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: park ys, kim hy, chang ws, lee ph, sohn yh, chang jw. A comparison of ledd and motor scores following stn-dbs treatment in patient with young onset vs late onset parkinson's disease. Neuromodulation: technology at the neural interface. 2010;13(4):255-260. Summary: the authors compared the role of subthalamic nucleus deep brain stimulation (stn-dbs) in the management of medically refractory idiopathic parkinson's disease in patients with relatively young onset (b)(6) parkinson's disease (yopd) and patients with relatively late onset parkinson's disease ((b)(6), rlopd). Between (b)(6) 2000 and (b)(6) 2008, the authors treated 132 patients, of these patients, 33 (25%) met disease onset criteria, and were included in the study sample: 18 (10 men, eight women) yopd patients, and 15 (six men, nine women) rlopd. Peroperative dyskinesia was more common in yopd patients and, psychotic problems were more common in rlopd patients. Our results suggest the age of onset does not influence response to stn-dbs parkinson's disease patients. There were no differences in postoperative weight gain between the two groups. There was no mortality related to stn-dbs in our study. No patient required immediate stimulator repositioning immediately following stn-dbs. Reportable event: it was reported that one rlopd patient had an epidural hematoma and craniotomy due to a motor vehicle injury three years following the procedure. The authors did not remove the right proximal electrode, but the stimulation was turned off as the electrode had migrated. See literature article with mfr report# 3007566237-2011-02256. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. The patient information provided in section a is the average for all the patients within the rlopd group. At this time, no additional information was available, additional information regarding the patient, event and outcome has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2032517


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« Reply #20 on: November 06, 2013, 12:55:38 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/11/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. At this time, no additional info was available, additional info has been requested.
 
Event Description

Literature: blomstedt p, sandvik u, tisch s. Deep brain stimulation in the posterior subthalamic area in the treatment of essential tremor. Mov disord. Jul 30 2010; 25(10); 1350-1356. Summary: to evaluate the posterior subthalamic area (psa) as a target for deep brain stimulation (dbs) in the treatment of essential tremor (et). Twenty-one pts with et were included in this study from 2004-2007. The group consisted of seven women and 14 men; with a mean age of (b)(6) years. All pts were evaluated before and 1 year after surgery. Dbs in the psa resulted in a marked reduction of tremor. A marked microlesional effect was noticed in 83% of the pts on introduction of the electrode, and due to continued absence of tremor, the stimulation did not need to be started in 35% before discharge from the hospital. No pt had simultaneous stimulation of two ipsilateral electrodes. No severe or permanent complication occurred. No hemorrhages or infections were encountered in this series. Reportable event: four pts experienced mild dysphasia that regressed. These four received an additional ipsilateral electrode (two stn, one vim, and one psa) in the psa due to suspected sub-optimal positioning of the first electrode.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1888957

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« Reply #21 on: November 06, 2013, 12:56:08 AM »

Model Number IPGNEURO
Device Problem Loose or intermittent connection
Event Date 05/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that on (b)(6) 2010, a pt in a controlled trial of deep brain stimulation for obsessive compulsive disorder reported a sudden worsening of depressive symptoms. When checked, impedances in the right electrode were reportedly high. It was decided there was a loose connection somewhere between the wiring of the implanted device and the right electrode. Surgical intervention to connect the loose connection was scheduled for (b)(6) 2010. Additional info has been requested, a follow-up report will be sent if additional info becomes available.
 
Manufacturer Narrative

(b)(4). Reason for late mdr due to implementation of process improvement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1887407

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« Reply #22 on: November 06, 2013, 12:56:30 AM »

Model Number IPGNEURO
Device Problem No Information
Event Date 09/28/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported patient had deep brain stimulation (dbs) system in 2004 and changed to implantable pulse generator (ipg) in (b)(6) 2008. According to patient, "the incision on the left side head occurred purulence about a month ago". When he returned to the hospital for programming, physician identified it as infected. After communicating between patient and company, physician decided to remove the infected electrode. The surgery was planned for (b)(6) 2010. The lead was explanted. At the time of this report, no further details were reported. Add'l info was requested and will be provided when it becomes available.
 
Manufacturer Narrative

(b)(4): analysis results were not available at the time of this report. A f/u report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885205
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« Reply #23 on: November 06, 2013, 12:56:51 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/26/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. The patient information provided in section a is the average for all the patients. At this time no additional information was available, additional information has been requested.
 
Event Description

Literature: fasano a, romito lm, daniele a, et al. Motor and cognitive outcome in patients with parkinson's disease 8 years after subthalamic implants. Brain. Sep 2010; 133(9):2664-2676. Summary: the authors evaluated a series of 32 consecutive patients who received continuous stimulation; 20 of these were monitored for 8 years. The authors indicated that at 8 years there was no significant increase of side-effects when compared with 5-year follow-up and therapy is a safe procedure with regard to cognitive and behavioral morbidity over long-term follow-up. However, the global benefit partly decreases later in the course of the disease, due to progression of parkinson's disease and the appearance of medication-and stimulation-resistant symptoms. Reportable event: it was reported that in one patient one electrode was removed due to a local infection. The patient experienced a sudden severe decrease of the therapeutic efficacy of stn stimulation and quickly recovered after re-implant. It was unclear when the explants occurred (early after implant or later).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1898134

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« Reply #24 on: November 06, 2013, 12:57:14 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 04/01/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

Literature: vergani f, landi a, pirillo d, cilia r, antonini a, sganzerla ep. Surgical, medical, and hardware adverse events in a series of 141 patients undergoing subthalamic deep brain stimulation for parkinson disease. World neurosurg. Apr 2010;73(4):338-344. Summary: the authors reported a single center, retrospective analysis of complications in a large population of parkinsonian patients with a long-term follow-up (mean, 4. 6 years). A total of 141 patients underwent bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) between (b)(6) 1998 and (b)(6) 2007. In this series, neither seizures nor extradural/subdural hematomas were observed. Reportable event: one patient experienced an infection of the intracranial lead: the control mri showed a signal change in both t1 and t2 sequences along the lead. Cultures were negative; the patient underwent the removal of the infected electrode and was started on an antibiotic therapy. The pt was successfully reimplanted 6 months later after resolution of the infection. This complication required a longer in-hospital stay for the patient however, the patient did not show significant comorbidity.
 
Manufacturer Narrative

(b)(4). At this time no additional information was available. Additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1895251
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« Reply #25 on: November 06, 2013, 12:57:42 AM »

Model Number IPGNEURO
Device Problem Malposition of device
Event Date 04/01/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

Literature: vergani f, landi a, pirillo d, cilia r, antonini a, sganzerla ep. Surgical, medical, and hardware adverse events in a series of 141 patients undergoing subthalamic deep brain stimulation for parkinson disease. World neurosurg. Apr 2010;73(4):338-344. Summary: the authors reported a single center, retrospective analysis of complications in a large population of parkinsonian patients with a long-term follow-up (mean, 4. 6 years). A total of 141 patients underwent bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) between (b)(6) 1998 and (b)(6) 2007. In this series, neither seizures nor extradural/subdural hematomas were observed. Reportable event: one patient experienced a malpositioning of the left subthalamic electrode resulted in a suboptimal control of parkinsonian motor signs on the right side. A second operation was carried out to replace the electrode, obtaining a successful reprise of stn dbs. This complication required a longer in-hospital stay for the patient.
 
Manufacturer Narrative

(b)(4). At this time, no additional information was available, additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1895244

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« Reply #26 on: November 06, 2013, 12:58:03 AM »

Model Number IPGNEURO
Device Problem Improper or incorrect procedure or method
Event Date 06/24/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: hu x, jiang x, zhou x, et al. Avoidance and management of surgical and hardware-related complications of deep brain stimulation. Stereotact funct neurosurg. 2010;88(5):296-303. Summary: the authors performed a retrospective analysis of patients who received dbs over a 9-year period from march 2000 to december 2008. This study included 161 patients (85 male and 76 female). Of them, 153 patients suffered from idiopathic parkinson disease, two from essential tremor, and 6 from dystonia. The patients ranged in age from 16 to 80 years with a mean of 63. 5 8 8. 7 years. Intraoperative and postoperative antibiotics were administered for 3-5 days. Preventive anticonvulsant treatment was initiated 3-5 days before surgery and discontinued 2-3 weeks after surgery. Postoperative ct scan was performed in all patients within 24 hr after electrode implantation. All patients were clinically followed up for 6-84 months (mean 14 months). Reportable event: the electrode was misplaced in two patients during the early days of dbs surgery when no intraoperative c-arm or mri was available for confirmation. Although the target position was confirmed by (b)(4) and intraoperative test stimulation showed good results, postoperative stimulation was ineffective with increased adverse effects. Subsequent mri showed that the electrodes were placed 4 mm deeper than the desired position. After proper adjustment of the electrodes under local anesthesia, good stimulation effects were achieved in the 2 patients.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time, no additional information was available, additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1907032

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« Reply #27 on: November 06, 2013, 12:58:24 AM »

Model Number IPGNEURO
Device Problems Fracture; Migration of device or device component
Event Date 06/24/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time no additional information was available, additional information has been requested.
 
Event Description

Literature: hu x, jiang x, zhou x, et al. Avoidance and management of surgical and hardware-related complications of deep brain stimulation. Stereotact funct neurosurg. 2010; 88(5): 296-303. Summary: the authors performed a retrospective analysis of patients who received dbs over a 9-year period from march 2000 to december 2008. This study included 161 patients (85 male and 76 female). Of them, 153 patients suffered from idiopathic parkinson disease, 2 from essential tremor, and 6 from dystonia. The patients ranged in age from 16 to 80 years with a mean of 63. 5 8 8. 7 years. Intraoperative and postoperative antibiotics were administered for 3-5 days. Preventive anticonvulsant treatment was initiated 3-5 days before surgery and discontinued 2-3 weeks after surgery. Postoperative ct scan was performed in all patients within 24h after electrode implantation. All patients were clinically followed up for 6-84 months (mean 14 month). Reported event: one patient (treated in another hospital 4 years ago) was treated for an electrode fracture; the authors confirmed the diagnosis by plain film radiography showing that 2 connectors had slipped to the neck with 1 electrode fractured. After replacement of the fractured electrode, proper adjustment of the connectors and embedment into the retromastoid occipital bone grooves, the symptoms were well controlled.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1907197
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« Reply #28 on: November 06, 2013, 12:58:46 AM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 09/01/2010
Event Type  Injury   Patient Outcome  Hospitalization,Life Threatening,Required Intervention
Manufacturer Narrative

(b)(4). It is not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no additional info was available, additional info has been requested.
 
Event Description

Literature: hyam ja, de pennington n, joint c, et al. Maintained deep brain stimulation for severe dystonia despite infection by using externalized electrodes and an extracorporeal pulse generator. J neurosurg. Sep 2010;113(3):630-633. Summary: the authors present two cases of severe dystonia in which deep brain stimulation was maintained despite the presence of infection at the site of the pulse generator, using ongoing stimulation by externalization of electrode wires and an extracorporeal pulse generator. This allowed the infection to clear and wounds to heal while maintaining stimulation. Reportable event: a (b)(6) girl with a 6-year history of medically intractable generalized tonic dystonia (dyt1 negative) underwent bilateral implantation of deep brain electrodes in the globus pallidus internus. Six months after the procedure, there was a 65% decrease in her bfmdrs score. This marked improvement gave her the ability to play independently for the first time, but 10 months after surgery she dislodged one of her electrodes while testing this freedom by sliding down a staircase on her abdomen. Her symptoms worsened, and her displaced electrode was revised. Following revision she developed a spreading infection from the abdominal would that failed to respond to broad-spectrum intravenous antibiotics. She developed signs of systemic sepsis, and the entire dbs system was removed. The sudden loss of stimulation precipitated a dystonic crisis, which compromised her respiratory function and necessitated emergency intubation and ventilation for 21 days. To allow wearing of ventilatory support, a dbs system was implanted despite the likely continued presence of infection. Over the next 6 years she underwent 11 further procedures to replace her pulse generators and deal with recurrent wound infections. Multiple wound swabs were taken but only one exhibited positive growth, a methicillin-sensitive staphylococcus aureus. Throughout most of this time, the pt received oral rifampicin and several courses of intravenous antibiotics. Dermatological skin patch testing was negative for sensitivity to pulse generator components. Although she remained systemically well, her dystonia deteriorated. Her entire system was revised 6 years after her original surgery, and the extension cables tunnelled along new paths to a new pulse generator implanted deep to the rectus abdominis muscle. Unfortunately after 6 months, the abdominal wound dehisced again. The authors believed that her recurrent wound problems were due to chronic hardware-related infection, and therefore, they externalized her existing pulse generator to the now extracorporeal, resterilized pulse generator. The pulse generator remained externalized for 4 months within an improvised carrying pouch; once all wounds were healed; new extension leads were tunnelled from the head to a new pulse generator placed in a new subpectoral wound. All antibiotics had been stopped for 18 months, inflammatory markers were normal, and all wounds had healed well. The pt's dystonia has improved again to the level initially achieved following her first surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1907359


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« Reply #29 on: November 06, 2013, 06:59:00 AM »

Device Problem Migration of device or device component
Event Date 12/31/2009
Event Type  Malfunction  
Event Description

Literature: york mk, wilde ea, simpson r, jankovic j. Relationship between neuropsychological outcome and dbs surgical trajectory and electrode location. J neurol sci. 2009; 287(1-2): 159-171. Summary: this article presents a study of an standardized eval of the location of the deep brain stimulation (dbs) electrode tip and the active electrodes, the surgical trajectory through which they were placed, and their relation to neuropsychological change scores in 17 pts implanted with bilateral subthalamic nucleus (stn) dbs using 6 month post-surgical magnetic resonance imaging data. Reportable event: one pt's left electrode migrated outside the radiologically defined stn. The pt did not receive good motor benefit following surgery. The left stimulation was eventually turned off following the mri results. The pt elected not to have a revision of the dbs electrode.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1586065

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« Reply #30 on: November 06, 2013, 06:59:21 AM »

Device Problem No Known Device Problem
Event Date 12/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: maldonado il, roujeau t, cif l, et al. Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage. Neurosurg, 2009;6(supp s):196-201. Summary: this article presents a retrospective study of all deep brain stimulation (dbs) electrode implants at a given institution between 1996 and 2007. The records were retrieved from a computerized database. A total of 478 electrodes were implanted in 220 consecutive procedures were performed in 194 pts. The aim of the study was to determine the safety of dbs technique consisting of a combination of routine general anesthesia, magnetic resonance imaging direct targeting, and a single penetration technique in a large population of pts undergoing implant secondary to movement disorders. No microelectrode recording or intraoperative stimulation was performed. Reportable event: two pts underwent electrode replacement due to infection. Reference mfr report#300756623720101233.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617817


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« Reply #31 on: November 06, 2013, 06:59:41 AM »

Device Problem Migration of device or device component
Event Date 12/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: maldonado il, roujeau t, cif l, et al. Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage. Neurosurg. 2009;6(supp s):196-201. Summary: this article presents a retrospective study of all deep brain stimulation (dbs) electrode implants at a given institution between 1996 and 2007. The records were retrieved from a computerized database. A total of 478 electrodes were implanted in 220 consecutive procedures were performed in 194 patients. The aim of the study was to determine the safety of dbs technique consisting of a combination of routine general anesthesia, magnetic resonance imaging direct targeting, and a single penetration technique in a large population of patients undergoing implant secondary to movement disorders. No microelectrode recording or intraoperative stimulation was performed. Reportable event: two patients underwent electrode replacement due to lead repositioning. Reference mfr report # 3007566237201001327.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617930

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« Reply #32 on: November 06, 2013, 07:00:04 AM »

Device Problem Fracture
Event Date 12/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: maldonado il, roujeau t, cif l, et al. Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage. Neurosurg. 2009;6(supp s):196-201. Summary: this article present a retrospective study of all deep brain stimulation (dbs) electrode implants at a given institution between 1996 and 2007. The records were retrieved from a computerized database. A total of 478 electrodes were implanted in 220 consecutive procedures were performed in 194 pts. The aim of the study was to determine the safety of dbs technique consisting of a combination of routine general anesthesia, magnetic resonance imaging direct targeting, and a single penetration technique in a large population of pts undergoing implant secondary to movement disorders. No microelectrode recording or intraoperative stimulation was performed. Reportable event: three pts underwent electrode replacement due to rupture. Reference mfr report #3007566237201001308.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617912

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« Reply #33 on: November 06, 2013, 07:00:27 AM »

Device Problem Migration of device or device component
Event Date 01/14/2010
Event Type  Malfunction  
Event Description

Literature: lee j-y, jeon bs, paek sh, lim yh, kim m-r, kim c. Reprogramming guided by the fused images of mri and ct in subthalamic nucleus stimulation in parkinson's disease. Clin neurol neurosurg. 2010; 112(1): 47-53. Summary: this article presents a study of 65 pts with parkinson's disease who underwent bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) between march 2005 and september 2006 and had been managed for at least 6 months within conventional programming based on physiological responses. The aim of the study was to evaluate the usefulness of a visual info about the location of the contacts in dbs programming, and compare the outcome of stn before and after reprogramming guided by the fused image of mri and ct. Reportable event: some pts appeared to have a significant shift in the location of the electrodes between the immediate and 6-month post-operative ct. The shift moved in the ventral direction. The shift was felt to be partly due to csf leakage during the operation. No pt treatment or outcome was reported. Reference mfr report #3007566237201001755. See literature article attached to mfr report# 3007566237201001696.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1628499

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« Reply #34 on: November 06, 2013, 07:00:50 AM »

Model Number IPGNEURO
Device Problem Fracture
Event Date 02/28/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: pereira eac, wang s, paterson dj, stein jf, aziz tz, green al. Sustained reduction of hypertension by deep brain stimulation. J clin neurosci. 2010;17(1):127-127. Summary: the article describes sustained, significant, reduction of hypertension in a (b) (6) male implanted with dbs for facial pain refractory to both pharmacological analgesia and motor cortex stimulation. Reportable event: it was reported the patient underwent surgery at 8 months post implant after an electrode fracture due to mild accidental head trauma. The patient underwent revision surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656947

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« Reply #35 on: November 06, 2013, 10:55:03 AM »

Device Problem No Known Device Problem
Event Date 10/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

 
Event Description

Literature: vanderhorst vg, papavassiliou e, tarsy d, shih lc. Early brain abscess: a rare complication of deep brain stimulation. Mov disord. 2009; 24(9): 1396-1397. Summary/reportable event: postoperative ct scan of the brain showed normal postsurgical changes immediately post-op. On postoperative day 3, the pt developed confusion and fever and was readmitted. There was no evidence of scalp infection at the surgical site. The pt had fluctuating inattentiveness, incoherent speech without aphasia, and left leg hyperreflexia. White blood cell count (wbc) was 15,000. Cerebrospinal fluid (csf) contained 135 wbcs, 359 rbcs, protein 51 mg/dl, glucose 98 mg/dl. Serial brain ct scans with and without contrast over the next 4 days were normal. Empirical treatment included intravenous vancomycin and meropenem. Blood and csf cultures remained negative. Repeated csf studies 4 days after readmission showed 46 wbcs, 216 rbcs, protein 71 mg/dl, and glucose 71 mg/dl. Temperature normalized but alertness continued to fluctuate. No new neurological signs developed. Brain ct scan on postoperative day 8 showed a hypodensity surrounding the right dbs electrode without ring enhancement. Brain mri on postoperative day 10 demonstrated a ring enhancing lesion with surrounding vasogenic edema in the right frontal lobe. Following mri, right frontal craniotomy showed no evidence of scalp or subgaleal infection. Reddish-gray material was found subcortically, cultures of which grew enterobacter aerogenes. The right electrode was removed. Antibiotic treatment was changed to intravenous ertapenem and was continued for 6 weeks. Mental status normalized within 2 weeks. Repeat mri at 6 weeks showed near resolution of the infection.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1562460



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« Reply #36 on: November 06, 2013, 10:56:29 AM »

Model Number UNKNOWN
Device Problem Migration of device or device component
Event Date 11/30/2009
Event Type  Malfunction  
Event Description

Literature: chan dtm, zhu xl, yeung jhm, et al. Complications of deep brain stimulation: a collective review. Asian j surg. 2009; 32(4): 258-63. Summary: this article presents an audit of all the pt's implanted with deep brain stimulation (dbs) between 1997 to the end of 2008 at one facility to assess complications arising from the 100 dbs electrode insertions and prevention of complications. Reportable event: one pt experienced electrode migration to the subcortical region after a minor fall. See literature article with mfr report #3007566237-2009-09382.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566592

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« Reply #37 on: November 06, 2013, 10:56:47 AM »

Model Number UNKNOWN
Device Problems Fracture; Migration of device or device component
Event Date 11/30/2009
Event Type  Malfunction  
Manufacturer Narrative

(b) (4).
 
Event Description

Literature: chan dtm, zhu xl, yeung jhm, et al. Complications of deep brain stimulation: a collective review. Asian j surg. 2009; 32(4): 258-63. Summary: this article presents an audit of all the pt's implanted with deep brain stimulation (dbs) between 1997 to the end of 2008 at one facility to assess complications arising from the 100 dbs electrode insertions and prevention of complications. Reportable event: one pt experienced electrode fracture at the distal end, close to the connector site. It was noted that the connector was not anchored properly and was migrating from the retroauricular region down to the neck level. The pulling and dragging force fractured the electrode. No pt symptoms, treatment, or outcome were reported. See literature article with mfr report #3007566237-2009-09382.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566589

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« Reply #38 on: November 06, 2013, 10:57:06 AM »

Device Problem Malposition of device
Event Date 11/30/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: chan dtm, zhu xl, yeung jhm, et al. Complications of deep brain stimulation: a collective review. Asian j surg. 2009; 32(4): 258-63. Summary: this article presents an audit of all the patients implanted with deep brain stimulation (dbs) between 1997 to 2008 at one facility to assess complications arising from the 100 dbs electrode insertions and prevention of complications. Reportable event: two patients experienced electrode malposition. Both patients suffered intolerable stimulation side effects and underwent revision. No patient outcome was reported. See literature article with mfr report #3007566237-2009-09382.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566212
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« Reply #39 on: November 06, 2013, 10:57:28 AM »

Device Problem No Known Device Problem
Event Date 11/30/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

 
Event Description

Literature: chan dtm, zhu xl, yeung jhm, et al. Complications of deep brain stimulation: a collective review. Asian j surg. 2009; 32(4): 258-63. Summary: this article presents an adult of all the patient's implanted with deep brain stimulation (dbs) between 1997 to 2008 at one facility to assess complications arising from the 100 dbs electrode insertions and prevention of complications. Reportable event: one patient experienced a stimulator pocket abscess requiring removal of the whole system. No patient outcome was reported. See literature with mfr report # 3007566237-2009-09382.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566219
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« Reply #40 on: November 06, 2013, 10:57:47 AM »

Model Number UNKNOWN
Device Problems Fracture; Electrical shorting
Event Date 11/30/2009
Event Type  Malfunction  
Event Description

Literature: chan dtm, zhu xl, yeung jhm, et. Al. Complications of deep brain stimulation: a collective review. Asian j surg. 2009; 32(4): 258-63. Summary: this article presents an audit of all the pt's implanted with deep brain stimulation (dbs) between 1997 to the end of 2008 at one facility to assess complications arising from the 100 dbs electrode insertions and prevention of complications. Reportable event: one pt experienced a sudden loss of stimulation two months after an initial good response. Testing revealed high current drainage leading to the battery running out. Exploration revealed short circuiting due to an electrode fracture at the miniplate anchorage site. No pt treatment or outcome was reported. See literature article with mfr report #3007566237-2009-09382.
 
Manufacturer Narrative

(b) (4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566588

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« Reply #41 on: November 09, 2013, 05:23:14 AM »

Device Problem Replace
Event Type  Injury   Patient Outcome  Other,Required Intervention
Manufacturer Narrative

 
Event Description

Journal ref: anheim m, batir a, fraix v, et al. Improvement in parkinson disease by subthalamic nucleus stimulation based on electrode placement: effects of reimplantation. Arch neurol. 2008;65(5):612-616. The objective is to evaluate whether reimplantation of electrodes in the stn can produce improvement in pts with poor results from surgery and with suspected electrode misplacement based on imaging findings. Reportable event: the only adverse effect of reimplantation was transient postoperative infection necessitating removal of the stimulator and extension lead, followed by reimplantation 2 months later with no sequelae. See mfg report 2182207200803751.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069471
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« Reply #42 on: November 09, 2013, 05:23:40 AM »

Device Problem Mislocation
Event Type  Injury   Patient Outcome  Hospitalization
Event Description

Journal ref: anheim m, batir a, fraix v, et al. Improvement in parkinson disease by subthalalmic nucleus stimulation based on electrode placement: effects of reimplantation. Arch neurol. 2008; 65(5):612-616. The objective is to evaluate whether reimplantation of electrodes in the stn can produce improvement in pts with poor results from surgery and with suspected electrode misplacement based on imaging findings. Reportable event: a 1-year postoperative study was undertaken in 7 consecutive pts with parkinson disease who, despite bilateral stn stimulation, experienced persistent motor disability and who were operated on for reimplantation a median of 16. 9 months later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069470
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« Reply #43 on: November 09, 2013, 12:30:20 PM »

Model Number IPGNEURO
Device Problems Disconnection; High impedance
Event Date 09/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported the patient's left brain electrode was not providing any real benefit and very little in the way of stimulation induced adverse effects (no dysarthria and less paresthesia than would be expected) even with monopolar at three contacts up to around 7 volts with high pulse widths (210). Her right brain electrode was providing almost complete tremor control at 1. 7 volts. Impedances were high in 0 monopolar and 0+2, 0+3 but everything else appeared fine during operating test stimulation. Current impedace readings were >4000 ohms x-rays revealed that the left lead had disconnected from the extension. The patient was scheduled for a revision in 2009. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1516345
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« Reply #44 on: November 09, 2013, 12:30:45 PM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 02/16/2009
Event Type  Malfunction 
Manufacturer Narrative

(b) (4). See manufacturer report number: 2182207200907584.
 
Event Description

Literature: o'sullivan d, pell m. Long-term follow-up of dbs of thalamus for tremor and stn for parkinson's disease. Brain res bull. 2009; 78(2-3): 119-121. Summary: dbs of the vim nucleus of the thalamus maintains long-term benefit for tremor due to essential tremor or to severe tremulous parkinson's disease. As far as bilateral stn stimulation, it maintains the benefit for the movement disorder aspect of parkinson's disease, such as tremor, rigidity and bradykinesia, but in the author's experience, does not prevent the progression of the disease and therefore is of no benefit for the non-dopaminegic aspects of the disease. Event: it was reported that the patient developed tolerance and response to stimulation failed over the follow-up period of 5 years. It was considered that the electrode had migrated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1516801
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« Reply #45 on: November 09, 2013, 12:31:11 PM »

Model Number IPGNEURO
Device Problem Intermittent continuity
Event Date 01/01/2009
Event Type  Malfunction 
Event Description

It was reported that since the device was replaced several months ago, the patient had been experiencing increased stimulation about 50 times per day. The patient stated it felt like the stimulation was going off and then on. The patient noted he was "a little dizzy". The logs noted no activations and impedances looked good at 486 ohms and current was 82, 1-, 2-, c+. One electrode was out of range, but not being used. The patient had device reprogrammed as contact 1 had previously been negative and was changed to contact 2 negative and increased the amplitude. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1516803

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« Reply #46 on: November 10, 2013, 03:38:45 AM »

Model Number IPGNEURO
Device Problem Internal fixation, revision of
Event Date 03/01/2005
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: lee jy, han jh, kim hj jeon bs, kim dg, paek sh. Stn dbs of advanced parkinson's disease, experienced in a specialized monitoring unit with a prospective protocol. J korean neurosurg soc. 2008:44(1): 26-35. Summary: this study evaluated 42 patients from 2005 - 2006, to assess the short term outcome of stn stimulation for patients with advanced pd evaluated in a 24h monitoring unit for movement disorder. Patient suffered adverse effects after dbs surgery. Patient underwent re-operation to reposition the electrodes, which were too medially located near or in the red nucleus. It was confirmed by the fused image of pre- and post- operative mri taken at 6 months after stn dbs. Patient had not experienced any improvement of symptoms with dysarthia and gait difficulty. Also, his mri 5 months after surgery demonstrated that the dbs electrodes were positioned off the stns. The right sided symptoms of the patient were dramatically improved after the revision surgery. See manufacturer report number: 2182207200902211.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353062
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« Reply #47 on: November 10, 2013, 03:39:17 AM »

Model Number IPGNEURO
Device Problem Implant, removal of
Event Date 10/10/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: mizukawa k, kondoh t, kohmura e. Intrathecal baclofen therapy in patients with ventriculoperitoneal shunt: a report of 3 cases. Jpn j neurosurg. 2008:17(10):794-798. Summary: review of 3 patients who have a ventriculoperitoneal shunt received intrathecal baclofen. It was reported that a head wound infection overtook a portion of the electrode and stimulation equipment. A ct scan performed shows a residual electrode for deep brain stimulation.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353060

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« Reply #48 on: November 10, 2013, 03:45:58 AM »

Model Number IPGNEURO
Device Problem Implant, removal of
Event Date 08/04/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

 
Event Description

Literature: martin aj, larson ps, ostrem jl, starr pa. Interventional magnetic resonance guidance of deep brain stimulator implantation of parkinson disease. Top magn reson imaging. 2009;19(4):213-221. Summary: review the use of interventional magnetic resonance image guidance for the implantation of deep brain stimulator electrodes. The patient developed an infection associated with the extension wire connecting the ipg to the dbs electrode. This required complete removal of the electrodes. This patient was subsequently re-implanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353057
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« Reply #49 on: November 10, 2013, 03:46:23 AM »

Model Number IPGNEURO
Device Problem Device remains implanted
Event Date 03/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

 
Event Description

Literature: gervais-bernard h, xie-brustolin j, mertens p, et al. Bilateral subthalamic nucleus stimulation in advanced parkinson's disease; five year follow-up. J neurol. 2009; 256(2): 225-233. Summary: this study assessed the long-term efficacy and safety or bilateral subthalamic nucleus (stn) stimulation in patients with advanced parkinson's disease (pd). A total consecutive patients with idiopathic pd treated with bilateral stn stimulation were enrolled from 1998 to 2002. It was reported that one pt required repositioning of one electrode because of a lack of efficacy or capsular side effects. This was performed within the first 6 months after the initial surgery. See manufacturer report number: 2182207200903228.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1378217
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« Reply #50 on: November 10, 2013, 05:17:55 AM »

Model Number IPGNEURO
Device Problem Internal fixation, revision of
Event Date 03/01/2005
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: lee jy, han jh, kim hj jeon bs, kim dg, paek sh. Stn dbs of advanced parkinson's disease experiencing in a specialized monitoring unit with a prospective protocol. J korean neurosurg soc. 2008:44(1):26-35. Summary: this study evaluated a total patients from 2005 - early 2006 to assess the short term outcome of stn stimulation for patients with advanced pd evaluated in a 24h monitoring unit for movement disorder. Patient suffered adverse effects after dbs surgery. Patient underwent re-operation to reposition the electrodes which were too medially located near or in the red nucleus. It was confirmed by the fused image of pre-and post-operative mri taken at 6 months after stn dbs. See manufacturer report number: 2182207-2009-02211.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353073

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« Reply #51 on: November 10, 2013, 05:18:31 AM »

Model Number IPGNEURO
Device Problem Internal fixation, revision of
Event Date 03/01/2005
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
Event Description

Literature: lee jy, han jh, kim hj jeon bs, kim dg, paek sh. Stn dbs of advanced parkinson's disease experienced in a specialized monitoring unit with a prospective protocol. J korean neurosurg soc. 2008:44(1):26-35. E. Summary: this study evaluated a total patients from 2005 - early 2006 to assess the short term outcome of stn stimulation for patients with advanced pd evaluated in a 24h monitoring unit for movement disorder. Patient suffered adverse effects after dbs surgery. 3d ct scan of patient examined immediately after stn dbs demonstrated that an electrode targeted on the left stn was indwelled in the third ventricle. The patient underwent re-operation two days after the initial surgery to reposition the left electrode. See manufacturer report number: 2182207-2009-02211.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353074


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« Reply #52 on: December 04, 2013, 06:06:13 AM »

Type of device:
 
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR   
Device brand name:
 
Activa   
Device manufacturer's name:
 
Medtronic Inc., Cardiac Rhythm Disease Management   
Date of this report:
(mm/dd/yyyy)
 
09/19/2013   
Describe the event
or problem:
 
Surgeon implanted a depth electrode successfully; upon completion, attempted to remove electrode through sheath. Electrode became stuck and upon further inspection was found to have a defect on one of the metal contact points. Electrode was explanted and taken off the field, and new electrode was implanted without incident. Patient experienced an extended OR time but no long term harm.   
The device(s) may have
caused or contributed to:
 
Potential for patient harm   

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=110073
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« Reply #53 on: December 06, 2013, 12:57:35 PM »

Model Number 7426
Event Date 11/04/2008
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported that a patient was told that ¿the electrode may be in the wrong place¿ since she had surgery in 2008 or 2009. It was stated that one doctor thought she had a stroke. It was noted that the area being stimulated ¿might be the wrong area,¿ thus the patient was going to have an mri to determine if that was the case. The patient reportedly never had a tremor before the surgery and ¿since she got the device put in her whole right side was affected but it was inconsistent. ¿ a supplemental report will be sent if any additional information is received.

 
Manufacturer Narrative
Concomitant products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2008, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 3387s-40, lot# v236672, implanted: (b)(4) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3462533
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« Reply #54 on: December 06, 2013, 12:58:27 PM »

Model Number 7426
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Product id 3387s-40 lot# v384611, implanted: 2010 (b)(6); product type lead product id 3387s-40 lot# v384611, implanted: 2010 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 7426, serial# (b)(4), implanted: 2008 (b)(6); product type implantable neurostimulator product id 3387s-40 lot# v135050, implanted: 2008 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2008 (b)(6); product type extension product id 7482a51, serial# unknown, implanted: 2013 (b)(6); product type extension product id 3387s-40 lot# v384611, implanted: 2010 (b)(6); product type lead product id 3387s-40 lot# v384611, implanted: 2010 (b)(6); product type lead. (b)(4).

 
Event Description
All the impedances were out of range due to reference electrode 3 so the extension was replaced today. It was noted that electrode 3 was used in the patient¿s programming. During surgery, the lead was tested in the twist lock. All the impedances read normal except all combinations with 3. Combinations with 3 were in the 3000¿s ohm range. The surgeon stated that electrode 3 looked a little bent at the extension end. Although 3,000¿s was ¿in range¿, it was still high. The surgeon went ahead with replacing the right extension. It was recommended to the patient to see a neurologist to try and program around electrode 3. On (b)(6) 2013, the company representative clarified that the right lead was the one that was tested. When the new extension was attached and impedances were checked, impedances remained high with electrode 3. The surgeon was going to see if the neurologist could program around it.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3481566
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« Reply #55 on: December 06, 2013, 01:01:07 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant products: product id 3389, lot # unknown, product type lead; product id 3389, lot # unknown, product type lead. (b)(4).

 
Event Description
Amtage, f. , lambeck, j. , rutsch, s. , prokop, t. , pinsker, m. , rijntjes, m. Behind the screen: pseudobulbar symptoms after deep brain stimulation. In: nikkhah g, pinsker m, eds. Stereotactic and functional neurosurgery. Vol 117: springer vienna; 2013:43-46. Summary: thalamotomy was formerly used to treat different tremor syndromes. Nowadays deep brain stimulation has become an established technique to treat different movement disorders. The combination of these two stereotactic interventions is rare. We present a patient which a right-sided tremor syndrome with and underlying pathology of combined essential tremor and parkinsonian tremor was successfully treated initially with bilateral deep brain stimulation in the subthalamic nucleus resulted in hemidystonia pathological laughing and crying, dysarthria and dysphagia, all due to dislocation of the stimulation electrode contacting the internal capsule. After discontinuation of the high-frequency stimulation these side-effects disappeared, but were then reactivated by an lcd television in stand-by mode. In this report we discuss the pathophysiology of pseudobulbar symptoms and pathological laughing and crying in context of thalamotomy and dislocated dbs electrodes. Furthermore, we report on the occurrence that magnetic fields in the household have an impact on deep brain stimulation, even if they are in stand-by mode. Reported event: one (b)(6) female patient with a history of right-sided tremor syndrome which was treated by a left-sided thalamotomy had a deep brain stimulation (dbs) implantable neurostimulator (ins) implanted in the subthalamic nucleus (stn) for her emerging parkinson¿s disease (pd). Postoperatively, the patient complained of slight dysarthria and dystonia in the right leg when using stimulation. Several years later, the patient reportedly displayed right-sided hemidystonia and aggravation of the dysarthria, in combination with pseudobulbar signs such as dysphagia and pathological laughing and crying (plc) when the amplitude was increased. Seven years after implant, the patient admitted herself to the hospital and had a cranial ct scan taken. The ct scan revealed a dislocation of the left-sided electrode, leading to a stimulation of the medial parts of the internal capsule with the two uppermost contacts. The reporter stated that the right-sided electrode was placed in a pronounced dorsolateral position, stimulating the internal capsule at low amplitude at the second proximal contact. The reporter stated that testing of the remaining contacts for therapeutic effect reportedly showed no benefit to the pd symptoms. The ins was then switched off and the dysarthria, dysphagia, plc and right-sided hemidystonia disappeared completely; the patient was then discharged from the hospital. The patient denied a revision of the electrodes, as she was experiencing well-being under medication. The reporter stated that the patient¿s pseudobulbar symptoms were due to dislocation of both dbs stimulation leads into the internal capsule and the hemidystonic syndrome was provoked by the high-frequency stimulation of the cortico-spinal tract within the left internal capsule. The reporter suggested that there was a concomitant vulnerability of the circuit due to the left-sided thalamotomy. The reporter stated that the left-sided thalamotomy was not able to provoke plc by itself, only additional high-frequency stimulation of the internal capsule resulted in plc and other pseudobulbar symptoms. It was noted that the right-sided stimulation of the internal capsule did not produce a clinically-apparent dystonia, but rather spasticity of the left leg, since stimulation of only a small amplitude was applied. The reporter stated that switching off the right-sided stimulation yielded no benefit with respect to the plc, suggesting that bilateral pathology was therefore not mandatory to provoke plc. One month later, the patient reported a reappearance of the pseudobulbar symptoms during housework. The patient reportedly presented with right-sided hemidystonia and showed identical pseudobulbar symptoms as previously, including dysarthria, dysphagia and plc. The reporter stated that an assessment of the ins revealed that the high-frequency stimulation was again provoking the symptoms. The patient stated that stimulation had not been restarted by herself or a physician. The patient stated that the symptoms had suddenly reappeared while leaning over the television screen, which was in stand-by mode. The reporter stated that the magnetic field of the television interfered with the stimulator and switched it on again. It was noted that the magnetic switch of the stimulator had not been inactivated and the amplitude of the left-sided stimulation parameters had not been set to zero when stimulation had been turned off. It was noted that the amplitude of the right stimulation contact was still set to zero. The reporter stated that after deactivating the stimulator, the pseudobulbar signs promptly disappeared again. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3466513
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« Reply #56 on: December 07, 2013, 07:22:11 AM »

Model Number 37601
Event Date 10/03/2013
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
Concomitant medical products: product id 3708660, serial# (b)(4), product type extension product id 3708660, serial# (b)(4). Product type extension. (b)(4).

 
Event Description
It was reported that there was a "misdirection of the electrode around the implantable neurostimulator (ins)". It was stated that this "necessitated medical or surgical intervention". X-rays had been taken that revealed a "dislocation of electrode" on (b)(6)-2013. The signs or symptoms were reported to be "pressure, pain above the ins location when moving the right arm, and pain in the head was growing". It was noted that there was no inflammation. Additional information received reported that there was "stimulator dislocation, loop of extension cable". It was not clear what the problem was. It was stated that this was "part of ongoing, but reduced complaint could still resolve as postoperative pain". That was also not clear. It was stated that this was "ongoing with no further action needed". It was reported that the device was surgically revised on (b)(6)-2013. It was noted that the stimulator and the extension were revised. X-rays were taken that revealed "loop of cable". It was not clear what this meant. It was stated that this event was possibly related to the implant procedure and it was related to the device or therapy. Signs or symptoms were reported as "pain in the stimulator and extension cable right neck". It was stated that this event resulted in "in-patient hospitalization". Additional information received reported that the extension migrated or dislodged.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3447275
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« Reply #57 on: December 08, 2013, 04:57:10 AM »

Model Number NEU_INS_STIMULATOR
Event Type  Injury   Patient Outcome  Disability,Required Intervention
Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant products: product id neu_unknown_lead, lot # unknown, product type lead; product id neu_unknown_lead, lot # unknown, product type lead; product id neu_ins_stimulator, serial # unknown, product type implantable neurostimulator; product id neu_ins_stimulator, serial # unknown, product type implantable neurostimulator; product id neu_unknown_lead, lot # unknown, product type lead; product id neu_ins_stimulator, serial # unknown, product type implantable neurostimulator; product id 7498, lot # unknown, product type extension. (b)(4).

 
Event Description
Mazzone, p. , brown, p. , dilazzaro, v. , stanzione, p. , oliviero, a. , peppe, a. , santilli, v. , insola, a. , altibrandi, m. Bilateral im plantation in globus pallidus internus and in subthalamic nucleus in parkinson's disease. Neuromodulation : journal of the international neuromodulation society. Summary: deep brain stimulation (dbs) of the subthalamic nucleus (stn) and of the pars interna of globus pallidus (gpi) is used to improve parkinsonian symptoms and attenuate levodopa-induced motor complications in parkinson¿s disease (pd) (dbs for pd study group, 2001). It is still not clear what the best anatomic structures to stimulate are or what the physiologic effects of dbs are. Most of the studies regarding dbs for parkinsonian symptoms have been conducted in patients with stn implantation, and these studies reported significant improvement in motor function with a relatively low rate of complication. The large experience of ablative surgery associated with the dbs experience of some groups worldwide indicate that gpi is a possible and very promising target for the management of parkinsonian symptoms. Surgical procedures have become safer and it is now possible, in selected cases, to target both structures in the same patient by means of the stereotactic system, ¿3p maranello¿ ((b)(4)). Using this system we were able to evaluate the clinical effects of simultaneous stimulation of both stn and gpi as well as evaluate the effects of isolated stimulation of each target. As it is known that there is a high intersubject variability of dbs, it seems relevant to test all different combinations of dbs in the same patient. We assessed the effects of dbs in 13 cases of pd, immediately after (30 min) stimulation and during chronic stimulation (weeks or months). Patients fell into two groups. The first (n= 7) responded to both gpi and stn stimulation equally. The second group (n= 6) was preferentially stimulated with only one target (stn = 5, gpi = 1). There was a good reduction in levodopa treatment following surgery. Most patients remained were chronically treated with bilateral stimulation of both targets. We conclude that dbs of stn and gpi was effective, with most patients treated chronically with both targets stimulated. Reported events: one patient experienced a hemorrhagic episode requiring surgical evacuation due to an arteriovenous malformation, which had not been detected during diagnostic neuroradiologic evaluation. The reporter stated that the patient suffered permanent right hemiparesis. One patient did not have correct positioning of electrodes on one side according to a postoperative mri. The reporter stated that the patient experienced somnolence, indifferentism, and a psychiatric disorder which were related to the wrong positioning of the left subthalamic electrode. It was noted that the electrode was repositioned later with the disappearance of these symptoms. Eight (8 ) patients experienced permanent weak phonation directly related to activation of deep brain stimulation (dbs). It was noted that these dbs related side effects were fundamentally linked to dbs of the subthalamic nucleus (stn), especially in patients with monopolar stimulation. The reporter stated that the side effects were not increased with simultaneous stimulation of both the stn and the globus pallidus internus (gpi). Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3493031
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« Reply #58 on: December 09, 2013, 06:01:46 AM »

Model Number NEU_INS_STIMULATOR
Event Date 05/24/2013
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative
(b)(4).

 
Manufacturer Narrative
The actual date of death was not provided. This date is based on the date of publication of the article. The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant products: product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id 3387-40, lot# unknown, product type lead; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id 3387-40, lot# unknown, product type lead; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator. (b)(4).

 
Event Description
Li, d. , cao, c. , zhang, j. , zhan, s. , chen, s. , sun, b. Subthalamic nucleus deep brain stimulation for parkinson's disease: 8 yearsof follow-up. Translational neurodegeneration. 2013;2(1):11. Doi: 10. 1186/2047-9158-2-11. Summary: the short-term benefits of bilateral stimulation of the subthalamic nucleus (stn) in patients with advanced parkinson¿s disease (pd) are well documented, but long-term benefits are still uncertain. The aim of this study is to evaluate the outcome of 8 years of bilateral stn stimulation to pd patients. In this study, 31 consecutive pd patients were treated with bilateral stn stimulation. Their functional status was measured using the activities of daily living section of the unified parkinson¿s disease rating scale (updrs-adl) at drug on (with medication) and drug off (without medication) states preoperatively and at 1, 5, and 8 years postoperatively. In addition, levodopa equivalent doses and stimulation parameters were also assessed. After 8 years of stn stimulation, the updrs-adl scores were improved by 4% at drug off status (p > 0. 05) and 22% at drug on status (p <(><<)> 0. 05) compared with baseline; the levodopa daily doses were reduced by 28% = (p <(><<)> 0. 05) compared with baseline; the stimulation voltage and pulse width w ere not changed, but the stimulation frequency was decreased remarkably compared with the 5 years of follow-up. Adverse events were observed in 6 patients, including misplacement of the electrode and skin erosion requiring further surgery. All events were resolved without permanent sequelae. 2 patients died of aspiration pneumonia 6 and 7 years after surgery. The marked improvement in updrs-adl scores were still observed after 8 years of bilateral stn stimulation with medication. Reported events: two patients had skin erosion in pocket site. The stimulators were repositioned. All events were resolved without permanent sequelae. Four patients had malposition of the electrodes, which was revealed by ineffectiveness of stimulation and mri. The electrodes were adjusted to alleviate the symptoms. All events were resolved without permanent sequelae. One patient died of aspiration pneumonia due to swallow disorders 6 years after surgery. One patient died of aspiration pneumonia due to swallow disorders 7 years after surgery. Unidentified number of patients developed axial symptoms suchas swallow, speech and gait disorders. As a result, the stimulation was reduced further to improve balance and speech functions, especially in some bradykinesia or rigidity dominated patients. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3202457
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« Reply #59 on: December 09, 2013, 06:04:35 AM »

Model Number NEU_INS_STIMULATOR
Event Date 08/01/2011
Event Type  Death   Patient Outcome  Death
Event Description
Servello, d. , sassi, m. , pacchetti, c. , mancini, f. , gaeta, m. , ricci, c. , menghetti, c. , porta, m. Hemorrhagic and repositioning risk factors related to intraoperative multitrack microrecording on a large series of patients treated for deep brain stimulation. Neurosurgery quarterly. 2011;21(3):194-198. Summary: we analyzed this complication in relation to simultaneous multitrack microrecording (mer) as observed in our experience. The possible contribution of mer to the precision of the dbs procedure was also evaluated. From october 1996 to january 2010, 532 consecutive procedures were performed at the unit of functional neurosurgery, division of neurosurgery irccs galeazzi in milan, and at the institution of besta irccs in milan by 2 of the authors (d. S. And m. S. ), on a total number of 272 patients. Findings: ischaemic/hemorrhagic complications were documented in 9 patients (1. 6%), and 5 of them presented with a neurological syndrome. Overall mortality was 3 patients (1. 1%), and was correlated with intracranial hemorrhage in 1 patient. Repositioning of incorrectly positioned electrodes was deemed necessary in 26 procedures (4. 9%) on 23 patients (8. 4%). Conclusions: although no consistent association was documented between the use of simultaneous intraoperative multitrack mer and hemorrhage, a statistically significant association was recorded between an incorrect positioning of the definitive leads, as reported in the postoperative magnetic resonance imaging controls or at the intraoperative computed tomographic (ct) scans, and the lack of "intraoperativemer". Dbs proves to be a safe and effective procedure even for novel indications. In our experience, no association was found between hemorrhagic risk and simultaneous multitrack mer. Reported event: 1 patient presented with a decreased level of consciousness;a left-sided frontal intraparenchymal hematoma of 2 cm m aximum diameter was reported at the postoperative mri checkup, whereas the immediate postoperative ct scan of the brain was normal. Hematuria was subsequently reported, and multiorgan failure together with acute renal insufficiency lead to the patient¿s death 1 month after surgery, whereas neuroradiologic checkups documented a progressive "readsorption" of the hematoma. Further information has been requested; a supplemental report will be submitted if additional information is received.

 
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant product: product type lead. (b)(4).

 
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that death was correlated with intracranial hemorrhage.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3207205
« Last Edit: February 03, 2014, 02:34:09 AM by dennis100 » Logged
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« Reply #60 on: December 09, 2013, 06:07:05 AM »

Model Number NEU_INS_STIMULATOR
Event Type  Death   Patient Outcome  Death,Required Intervention,Disability
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. It is also possible several events occurred in one patient. The patient information provided in section a is an average for all the patients. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, serial# unknown, product type: lead. (b)(4).

 
Event Description
Franzini, a. , cordella, r. , messina, g. , marras, c. E. , romito, l. M. , carella, f. , albanese, a. , rizzi, m. , nardocci, n. , zorzi, g. , zekay, e. , broggi, g. Deep brain stimulation for movement disorders. Considerations on 276 consecutive patients. J neural transm. 2 011;118(10):1497-1510. Doi: 10. 1007/s00702-011-0656-z. Summary: the links between stn dbs and advanced parkinson disease, and between gpi dbs and dystonia are nearly universally accepted by the neurologists and neurosurgeons. Nevertheless, in some conditions,targets such as the ventral thalamus and the zona incerta may be considered to optimize the results and avoid the side effects. Positive and negative aspects of current dbs treatments justify the research of new targets, new stimulation programs and new hardware. Since 1993, at the istituto nazionale neurologico ¿¿carlo besta¿¿ in milan, 580 deep brain electrodes were implanted in 332 patients. 276 patients were affected by movement disorders. The dbs targets included stn, gpi, voa, vop, vim, cm¿pf, czi, ic. The long-term follow-up is reported and related to the chosen target. Dbs gave a new therapeutic option to patients affected by severe movement disorders, and in some cases resolved life-threatening pathological conditions that would otherwise result in the death of the patient, such as in status dystonicus, and post-stroke hemiballism us. Nevertheless, the potential occurrence of severe complications still limit a wider use of dbs. At today, the use of dbs in severe movement disorders is strongly positive even if further investigations and studies are needed to unveil potential new applications, and to refine the selection criteria for the actual indications and targets. The experience of different targets may be useful to guide and tailor the target choice to the individual clinical condition. Reported events: 1. 2 patients had a massive brain hemorrhage with a fatal outcome. 2. 6 patients had permanent neurological deficits due to deep hemorrhage 3. 8 patients had transient neurological deficits due to deep hemorrhage. 4. 7 patients had post-operative seizures. 5. 26 patients had hardware removed due to infection. 6. 6 patients had hardware removed due to infection and had a cerebral abscess at the origin of the stereotactic trajectory. 7. 30 patients had a hardware failure. 8. 20 patients had a late electrode migration. 9. 2 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had a brain hematoma with hemiplegia. 10. 1 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had presented an unexplained fracture of the extracranic portion of the lead. It was noted that the patient underwent a successful lead replacement. 11. 2 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had monolateral removal of their systems due to infection. 12. 17 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had hypophonia. 13. 11 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had dysarthria. 14. 1 pediatric patient suffering from a sever from of secondary dystonia had bilateral implantation ofdeep brain stimulation (dbs) system in the globus pallidus interna (gpi) and was successfully treated for 2 years before the stimulation device on the right side became infected because of skin erosion of the head along the path of the connector. It was noted that a right pallidotomy was performed by the dbs electrode before its subsequent definitive removal. 15. 4 patients suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had migration of the electrode. It was noted that the complication was successfully managed. 16. 2 patients suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had breakage of the electrode. It was noted that the complication was successfully managed. 17. 5 patients suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had an infection. It was noted that the complication was successfully managed. 18. 1 patient suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had an intracranial hemorrhage. 19. 4 patient suffering from parkinson¿s disease with levodopa induced dyskinesia developed severe akinesia resistant to levodopa therapy after 4 years of chronic stimulation. 20. 3 patients had bilateral thalamic implants and had speech impairment. 21. 3 patients with severe syndromes characterized by high amplitude distressing tremor of bilateral limbs and head, and were completely invalid. It was further reported that these patients did not have restoration of finalistic movements and bilateral surgery was associated with speech impairment. 22. 1 patient with severe syndromes characterized by high amplitude distressing tremor of bilateral limbs and head, and was completely invalid. It was further reported that this patient did not have restoration of finalistic movements and bilateral surgery was associated with speech impairment. Additionally it was noted that surgery was followed by a relapse of the demyelinating disease. 23. 19 patients affected by advanced parkinson¿s disease had bilateral implants in the pre-lemniscal radiation (raprl) and had an incident of speech impairment of 36% and depression of 18%. 24. 4 patients affected by advanced parkinson¿s disease had asymmetrical implants in the pre-lemniscal radiation (raprl) and in the causal zona incerta (czi) on the contralateral side and had an incident of speech impairment of 36% and depression of 18%. Please refer to manufactures report # 3007566237-2013-02368 for additional information on a related event. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3233746
« Last Edit: February 03, 2014, 02:34:24 AM by dennis100 » Logged
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« Reply #61 on: December 10, 2013, 04:47:55 AM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative
 
Event Description
Journal reference: merello m, tenca e, lloret sp, et al. Prospective randomized 1-year follow-up comparison of bilateral subthalamotomy versus bilateral subthalamic stimulation and the combination of both in parkinson's disease patients: a pilot study. Br j neurosurg. 2008;22(3): 415-422. It has been suggested that potential risk of hemiballismus after subthalamotomy makes dbs preferable to ablation for ipd treatment; however, cost and the need for regular electrode control have also been observed as disadvantages to stimulation. The objective was to compare efficacy and safety of different surgical approaches to stn, in a prospective randomized pilot study. Sixteen consecutive ipd patients randomized to receive either: bilateral stn-dbs (bs group), bilateral subthalamotomy (bl group), or unilateral subthalamotomy plus contralateral stn-dbs implantation (l/s group), and followed for 12 months after surgery. Reportable event: one pt in the bs group presented a large subcortical brain haematoma. A cannula for the dbs catheter introduced, at which time the pt suddenly developed a facial deviation, loss of consciousness and progressive hemiplegia. The cannula was removed and an interoperative mri scan performed confirming a thalamic haematoma. A few hrs later, clinical deterioration and progressive worsening of the haematoma, confirmed by a new mri scan, required the pt to undergo open surgery for eval. The pt died from clinical complications after 20 days in intensive care. See mfg report 2182207200805745.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161165
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« Reply #62 on: December 30, 2013, 07:09:46 AM »

Model Number ITREL II MODEL 7424
Event Date 01/11/2001
Event Type  Malfunction   Patient Outcome  Other
Event Description
Right-handed pt had 12 years of parkinson's disease. Medications which lost efficacy for the last two years. Placement of deep brain stimulator into the left subthalamic nucleus was performed that initially resulted in a moderate improvement of dyskinesia. In 1/01, during regular visit for reprogramming, no response was found to higher parameter (4v) of stimulation. An x-ray showed a small defect in the electrode about 1. 5' below the connector.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=316315
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« Reply #63 on: December 30, 2013, 07:11:33 AM »

Lot Number L56799
Event Date 09/18/2002
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
Subject had deep brain stimulator placed for control of essential tremor. Over the past four mos. Subject has exhibited return of tremor requiring need for frequent reprogramming and increased amplitude at high levels. Finally, stimulation became totally ineffective as the pulse generator discharged due to the high power requirements. Mri scans confirmed electrode migration from original target. Subject was brought back for surgery to remove existing electrode and insert new electrode to correct target. Subject has now gained good tremor control at acceptable power usage.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=420409
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« Reply #64 on: January 03, 2014, 06:41:13 PM »

Model Number 3389
Device Problem Explanted
Event Date 03/09/2006
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
Manufacturer Narrative
(b)(4).

 
Event Description
The mfr received returned products with no documented reason for retrieval. The device was explanted in (b)(6) 2006 after approx 44 months implant duration. Add'l info was requested from the physician. The hcp reported on (b)(6) 2006, that the pt had sustained a head laceration and presented in (b)(6) 2006 with a sign of infection; pt symptom of tissue redness. The pt injury was located in proximity to the implanted electrode, which reportedly led to the infection. The pt does not have meningitis. The date of onset or diagnosis of the infected laceration was (b)(6) 2006; the hcp indicated the pt was asymptomatic on (b)(6) 2006. The pt was administered oral antibiotics and partial device system explant occurred on (b)(6) 2006. The ins was interrogated at follow-up and the pt realized removal of the electrode and left-sided pulse generator. The hcp reported the primary location of the infection was the lead track. The hcp further stated the device was removed to prevent a life-threatening infection. The dbs lead was explanted, but has not been returned to the mfr for analysis. It is unk if a culture was obtained. The hcp provided the wound was healing in (b)(6) 2006 subsequent to device removal in (b)(6) 2006 with no evidence of active infection. In (b)(6) 2006 the hcp indicated to the mfr the infection had resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2662678
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« Reply #65 on: January 08, 2014, 03:12:51 PM »

Device Problem Migration of device or device component
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
Journal reference: cersosimo et al. "pallidal surgery for the treatment of primary generalized dystonia: long-term follow-up. " clin neurol neurosug 2008; 110(2): 145-150. The aim of this study was to determine the outcome of 10 pgd pts who underwent bilateral gpi dbs, bilateral pallidotomy, or combined unilateral dbs and contralateral lesion dbs in a single center and have been followed, in most cases, for at least 6 years after surgery. Eight pts had dbs treatment. One pt, male, with dbs required another surgery due to electrode migration. There was a transient worsening of dystonia after the surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1005285
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« Reply #66 on: January 08, 2014, 03:13:28 PM »

Device Problems Migration of device or device component; Misplacement
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
Journal reference: cerosimo et al. "pallidal surgery for the treatment of primary generalized dystonia: long-term follow-up. " clin neurol neurosurg 2008: 110(2):145-150. The aim of this study was to determine the outcome of 10 pgd pts who underwent bilateral gpi dbs, bilateral pallidotomy, or combined unilateral dbs and contralateral lesion dbs in a single center and have been followed, in most cases, for at least 6 years after surgery. Eight pts had dbs treatment. One pt, female, with dbs required another surgery due to electrode (n=2) misplacement and migration along with a poor response. There was a transient worsening of dystonia after the surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1005260
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« Reply #67 on: January 08, 2014, 03:14:16 PM »

Model Number 3389
Device Problem Device, or device fragments remain in patient
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Journal reference: smelding et all. "pathological gambling after bilateral subthalamic nucleus stimulation in parkinson disease" journal of neurol neurosurg psychiatry 2007, 78:517-519. The article describes a case study involving a male patient being treated for advanced parkinsons disease with dbs, developed pathological gambling shortly after surgery for bilateral stm stimulation. Other symptoms included: a slight cognitive decline, memory loss, difficulty finding words, vivid dreams, impulsivity, depression and emotional liability. The patients family relationships deteriorated and he attempted suicide several times. He was subsequently admitted to the hospital neurological ward. Ct evaluation of the electrodes found one electrode to be somewhat off the original target site (2mm). The gambling desire resolved with discontinuation of pergolide and a change in the electrode stimulation contact point. He regained his interest in family and hobbies. Further testing found his neuropsychological status remained unchanged.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=930474
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« Reply #68 on: January 08, 2014, 03:14:42 PM »

Model Number 3387
Device Problem Electrode contact(s), problem with
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
The patient reported the second electrode is not functioning; the "second band on the left probe" has not worked since it was installed. Add'l information has been requested by medtronic from the health care professional regarding the reported event. A supplemental mdr follow-up report will be sent to fda if add'l information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=934374
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« Reply #69 on: January 08, 2014, 03:15:41 PM »

Device Problem Migration of device or device component
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Journal reference: broggi, et al: "deep brain stimulation as a functional scalpel. " acta neurochir suppl 2006, 99:13-19. The article reports on the results of a retrospective study involving the treatment of several drug-resistant neurological syndromes with deep brain stimulation (dbs). A total of leads were implanted in patients. A number of patient complications were reported as part of the study results. Reportable events: twelve patients (dbs lead n=12) experienced late electrode migration, some of which occurred in pediatric patients. Symptom, treatment and outcome information was not provided.

 
Manufacturer Narrative
Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each patient, the devices used and the complications experienced was not provided. It is possible that each patient may have experienced more than one complication.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=939864
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« Reply #70 on: January 08, 2014, 03:18:55 PM »

Event Type  No Answer Provided 
Manufacturer Narrative
This report is being filed under exemption.

 
Event Description
Journal reference: voges j. , waerzeggers y. , maarouf m. , et al. "deep-brain stimulation: long-term analysis of complications caused by hardware and surgery-experiences from a single centre. " journal of neurology, neurosurgery and psychiatry. 2006; 77(7):868-872. The article discussed the surgery-related and hardware-related complications of deep-brain stimulation (dbs) at a single centre. A retrospective analysis of 262 pts implanted from 1996 to 2003 with a dbs lead (models 3387 or 3389), extension (model 7495), and neurostimulator (models 7424, 7426 or 7428). Reportable events: lead (n=1) - one pt experienced unilateral moderate motor weakness that resolved completely. The 7495 extension (n=3) - three pts experienced severe subcutaneous bleeding events related to use of the tunneling tool. Lead (n=2) - misplacement of the electrode tip beyond the caudal border of the stn in two pts caused permanent vi cranial nerve palsy. Lead (n=1) - one pt who underwent postoperative ct examination after intraoperative loss of csf developed a subarachnoid haemorrhage incidentally. The bleeding resolved without sequelae. No symptomatic ich was observed. Neurostimulator (n=1) - one pt developed a hematoma at the ipg implantation site which had to be surgically removed. Lead (n=1) - one pt (a child with myoclonic syndrome), leakage of the csf at the site of trephination caused a skin infection, necessitating complete removal of the dbs system. Because the child had not gained immediate improvement from dbs, the parents did not give permission for reimplantation. Lead (n=3) - three pts experienced lead breakage after a fall. The leads were replaced. The 7495 extension (n=1) - one pt experienced extension breakage. The cause of the breakage is unk. The extension was replaced. The 7495 extension (n=4) - four parkinson pts experienced discomfort from the extension or extension connector which required additional surgery. Resection of scar tissue led to sustained improvement of the complaints. The 7495 extension (n=1) - one dystonia pt experienced discomfort from extension or extension connector and scar tissue resection helped resolve the complaint. Lead (n=5) - five pt's experienced lead migration and surgical repositioning. The 7495 extension (n=1) - one pt experienced extension migration and surgical repositioning. Neurostimulator (n=1) - one pt developed a seroma requiring surgical revision. The 7495 extension (n=7), lead (n=5), neurostimulator (n=3) - fifteen pts experienced skin infections. Four pts the onset was within 30 days after surgery and in 11 pts the infection occurred 15 months after the initial surgery. In no pt had the infection extended intracranially. Systemic antibiotics were given to 5 of 15 pts. Drugs stopped the inflammation in three pts, and the entire stimulation system was removed in the remaining two. All other pts underwent immediate surgery for wound debridement and removal either of parts (n=3) or of the entire system (n=7). In all cases treated with surgery for skin infection bacterial cultures yielded skin flora.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=921679
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« Reply #71 on: January 09, 2014, 11:14:27 AM »

Model Number 3389S
Device Problems Dislodged; Device remains implanted; Implant, reprogramming of
Event Date 01/16/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The mfr rep reported, the set screw damaged the dbs lead causing the number three electrode to become dislodged. The lead was left in place with the pt scheduled to come back in three weeks to check therapy efficacy. The pt was seen three weeks later, and had reported a loss of efficacy which was unrelated to the stimulation therapy. The loss of therapy had happened three days prior to the recheck. The pt remained at home in good condition. The pt was scheduled to see the hcp possible reprogramming the following week. Add'l info has been requested from the hcp but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1001718
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« Reply #72 on: January 09, 2014, 02:15:54 PM »

Model Number 3389S
Device Problems Electrode contact(s), problem with; Material frayed; High impedance; Insulation, detached; Device remains implanted; Repair; Tears, rips, holes in device, device material
Event Date 04/22/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that the number three electrode contact had appeared frayed or damaged after removal of the accessory lead cap cover during the case. Exposed wires seen in the area contacted by the cap and the distal tip material had appeared stretched. The lead had separated easily from the temporary cap during the stage ii procedure; the surgeon had followed manufacturer instructions for use. The lead damage had been attributed to use of the temporary lead cap. The lead was subsequently inserted into the extension and the system connected after the surgeon cut-off the #3 contact in order to attach the extension and connect the system. Post-operative impedance readings obtained showed all unipolar electrode pairs were between 830 and 840 ohms, at 37 to 39 usec and a short circuit was suspected. Add'l impedance data obtained at 3v, showed values in the mid-500 range. No pt symptoms or injury was reported.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1052528
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« Reply #73 on: January 09, 2014, 02:17:49 PM »

Model Number 3387
Device Problems Migration of device or device component; Replace
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Journal reference: yokochi f, burbaud p. Neurosurgery for neuroacanthocytosis. In: walker rh, saiki s, danek a, eds. Neuroacanthocytosis syndromes ii. Another country: springer-verlag; 2008:255-269. Neuroacanthocytosis (na) is a group of neurodegenerative diseases characterized by the presence of acanthocytes in peripheral blood and various types of involuntary movements which are often resistant to medical treatment. We report data concerning four na patients who benefited from functional surgery: two had pallidotomies and two had deep brain stimulation (dbs) of the internal pallidum (gpi). In the patients who underwent dbs. Gpi 40hz stimulation gave the best clinical benefit, improving chorea without an effect upon hypotonia. Higher frequency stimulation (130hz) was effective for dystonia but increased chorea, worsened dysarthria and induced drooling. Reportable event: pt 3 was a man with an 8-year history of a choreatic-dystonic syndrome, dysarthria and generalized epileptic seizures who presented with recurrent distressing tasteless belching. Two months after dbs, a partial relapse occurred, and belching and breathing dyskinesia reappeared, although tongue-biting did not. Changes in stimulation settings were ineffective. Mri revealed that the rt electrode needed to be repositioned. The first rt electrode was left in place and a second electrode was introduced more medially on the same side, 3 months after this second intervention, chorea, belching and dysarthria were improved by gpi 40hz stimulation. The dystonia sub-score was slightly improved by 120hz gpi stimulation but at this frequency, chorea and dysarthria were worsened with drooling. There was no effect on gait whatever the settings used. Gpi stimulation at 10 hz was ineffective.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1052630
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« Reply #74 on: January 09, 2014, 02:18:37 PM »

Model Number 3387
Device Problem Explanted
Event Date 11/30/2007
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
It was reported the pt experienced erosion of the right side connector, and the wire was exposed. The pt was taken to surgery and the electrode was removed. The pt received antibiotics and was discharged to home several days later. Add'l info noted the wound had healed well as of 2008. The pt subsequently died of other complications on the following month.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053766
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« Reply #75 on: January 09, 2014, 05:58:27 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 10/01/2006
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the pt underwent removal of the deep brain stimulation electrodes. No symptoms or outcome were reported. Add'l info has been requested, a f/u report will be submitted if add'l info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1064330
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« Reply #76 on: January 09, 2014, 05:59:17 PM »

Model Number 3387S
Device Problems Lead(s), breakage of; Replace
Event Date 02/08/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that there was a possible fracture in the electrode of the lead (the side was not reported). The hcp believed it was caused by the set screw. It was reported that the lead was implanted and the patient was doing well post-implant. Additional information received from the hcp indicated the patient experienced under stimulation. The lead was explanted and replaced. Both the patient's right and left extensions and pulse generators were also replaced. The patient recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1056467
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« Reply #77 on: January 09, 2014, 06:00:33 PM »

Model Number 3389
Device Problem Improper or incorrect procedure or method
Event Type  Other   Patient Outcome  Other
Event Description
Journal reference: blomstedt p, hariz mi, lees a, et al. Acute severe depression induced by intraoperative stimulation of the substantia nigra: a case report. Parkinsonism relat disord 2008;14(3):253-256. Reportable event: we present a man with parkinson's disease (pd) who underwent bilateral stimulation in the subthalamic nucleus (stn). During the intraoperative evaluation, stimulation through the lowest contact in the right stn area, induced an acute depressive state, during which the pt was crying and expressing that he did not want to live. The pt returned to his normal state of mood within seconds after the cessation of stimulation. Repeated blinded stimulations resulted in the same response. Immediate postoperative magnetic resonance imaging (mri) revealed that the lowest contact of the right electrode was located in the substantia nigra.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1059587
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« Reply #78 on: January 09, 2014, 06:01:37 PM »

CRIMINAL
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« Reply #79 on: January 12, 2014, 06:06:37 PM »

Model Number 3389
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: tabbal/safety and efficacy of subthalamic nucleus deep brain stimulation performed with limited intraoperative mapping for treatment of parkinson's disease. This study implanted 110 patients with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for the treatment of parkinson's disease. The objective of the study was to establish the safety and efficacy of bilateral stn-dbs performed during an expedient procedure with limited intraoperative mapping. The investigators used t2-weighted magnetic resonance imaging guidance to target the stn. Adverse events are reported. One patient experienced affective changes due to the excessively deep electrode placement, which resulted in surgical withdrawal of the electrode by a few millimeters.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1018980
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« Reply #80 on: January 12, 2014, 06:07:30 PM »

Model Number 3387
Device Problem Explanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Journal reference: hung sw, hamani c, lozano am, et al. Long-term outcome of bilateral pallidal deep brain stimulation for primary cervical dystonia. Neurology. 2007;68:457-459. This article reports long-term outcomes for a series of 10 consecutive patients with idiopathic cervical dystonia (cd) who underwent bilateral globus pallidus internus (gpi) deep brian stimulation (dbs) between early 2000 and may 2005. Short term outcomes were previously reported for the first 4 patients (reference provided in article). Quadripolar electrodes (model 3387, medtronic) were inserted in all patients, and post-operative mri confirmed the location. Implantable pulse generators were placed several days later. Programming was started after the pallidotomy-like effect vanished, and patients had returned to preoperative clinical status. The follow-up period was 31. 9 +/- 20. 9 months (range, 12-67 months). Six patients were termed good responders, and 4 patients were partial responders. One patient (patient 4) had the left gpi electrode removed due to infection 1 years after surgery. Benefits from unilateral stimulation continued for another 2 years, when his cd returned to preoperative baseline. The left gpi electrode was repositioned, and the patient completely recovered the previous benefit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1014465
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« Reply #81 on: January 13, 2014, 01:33:18 AM »

Model Number 3387
Device Problems Explanted; Lead(s), breakage of; Replace
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
Literature reference: c hamani, et al. "deep brain stimulation for chronic neuropathic pain: long-term outcome and the incidence of insertional effect. Pain. 2006 (125) p188-196. The article is a retrospective analysis of long-term results of deep brain stimulation (dbs) for the treatment of neuropathic pain on 21 patients. One pt suffered an iatrogenic fracture of the dbs electrodes when they were reconnected to external cables for testing. The pt required a new surgical procedure to remove/replace the fractured electrodes.

 
Manufacturer Narrative
As a result of an internal audit, this report is being submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1023519
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« Reply #82 on: January 13, 2014, 01:33:48 AM »

Model Number 3387S
Device Problem Lead(s), breakage of
Event Date 02/08/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that there was a possible fracture in the electrode of the lead. The hcp believed it was caused by the set screw. It was reported that the lead was implanted and the pt was doing well. Add'l info has been requested from the hcp, but was not available as of the date of this report. A follow-up will be sent if add'l info is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1025685
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« Reply #83 on: January 13, 2014, 01:34:54 AM »

Model Number 3389
Device Problems Explanted; Lead(s), breakage of; Migration of device or device component; Replace
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported, the pt experienced pain due to a loss of stimulation effect after lead migration. An x-ray revealed two deep brain stimulation electrodes migrated several centimeters even though both electrodes were anchored with a stimloc lead securement device. This extensions and neurostimulator were explanted in 2008. The neurostimulator had been implanted in the abdominal pocket but not fixed. The extension connectors were located at the base of the patient's neck. Further exploration found the extensions completely wound and rolled up (wrapped) around the neurostimulator. The right electrode was broken at the level of the extension connector. There was only a wire connecting the left electrode to the left extension connector. The right and left stimloc devices were closed, and the bases were correctly fixed. It was impossible to extract the deep brain stimulation electrodes. The left electrode and stimloc device were explanted. After the left electrode was replaced, the right electrode and stimloc device were explanted. The right stimloc device was not dismounted, it was unscrewed. The pt status is unknown. Refer to medwatch report # 6000153200801801.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1026198
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« Reply #84 on: January 13, 2014, 01:36:21 AM »

Model Number 3389
Device Problem Migration of device or device component
Event Type  Injury   Patient Outcome  Other,Required Intervention
Event Description
Journal reference: piacentini et al. "mood disorder following dbs of the left amygdaloid region in a dystonia pt with a dislodged electrode. " movement disorders 2008;23(1):147-150. The authors present a case report of a pt with downward migration of the electrode during dbs treatment for dystonia. The pt had resultant recurrence of dystonia and pain and depression and psychotic symptoms. Reportable event: a male with primary generalized dystonia had dbs placed in 2005 for severe dystonia with major trunk involvement and lumbar lordosis, which was a source of intense pain. Nine months later, the pt presented with a 4-month history of recurrence of dystonia and pain (i. E. , 5 mos after implantation). Additionally, the pt's mood deteriorated and the pt was depressed, irritable, had rage, anxiety, loss of appetite, and suicidal ideation. Electrode migration was confirmed by mri, ct, and skull x-ray. The left electrode tip was no longer in the gpi, but moved to the region of the amygdala. The left electrode was turned off and surgically removed. A new electrode was placed. The pt's dystonia improved soon after implant. Behavior and mood abnormalities improved gradually.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1029156
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« Reply #85 on: January 13, 2014, 01:38:31 AM »

Model Number 3387
Device Problems High impedance; Device remains implanted; Low impedance
Event Date 03/14/2000
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The hcp reported that while the pt's neurostimulator on the right side was turned on, the pt experienced dizziness and numbness on his left side. The symptoms subsided when the device was turned off. Impedances were checked and some of the unipolar pairs were >2000 ohms; electrodes 0 and 1 were <50 ohms. The pt was implanted for tourette's syndrome and hit his head often with his hand. An x-ray and ct scan were done 2/2008 and did not show lead movement or fracture. On a week later, the hcp reported electrodes 2 and 3 showed an impedance of 2000 ohms; electrodes 0 and 1 showed an impedance of 65 ohms. The hcp confirmed the pt had suffered a fall and hit his head. On the next day, the hcp reported that impedances were >2000 ohms on electrodes 2 and 3; electrodes 0 and 1 were <250 ohms. The pt symptoms were paresthesias and motor weakness. The hcp further reported on the following month that the pt had experienced a lack of effect, shocking, and sensory changes. Device reprogramming was done between five days prior to original month and the following month with limited effect. The hcp planned to do a revision of the extension and neurostimulator. On nine days later, the extension was replaced and still had abnormal impedances on some pairs. See mfr's report # 6000153200801420. The hcp planned to revise the lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1026400
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« Reply #86 on: January 13, 2014, 08:47:35 AM »

Model Number 3387S
Device Problems High impedance; Implant, reprogramming of
Event Date 01/28/2008
Event Type  Malfunction 
Event Description
The hcp reported impedances >2000 ohms on electrode 0 with every combination. The hcp stated the affected electrode is not needed to obtain therapy for coverage area; the hcp chose not to reprogram the electrode. No pt symptoms were reported. Refer to medwatch report # 2182207200801051.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1006650
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« Reply #87 on: January 13, 2014, 09:00:52 AM »

Model Number 3387
Device Problems Misplacement; Implant, repositioning of
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
Journal reference: tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030.

 
Event Description
Tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030. The article describes the results of a retrospective study of 38 parkinsonian pts, who underwent bilateral stn-dbs. The aim of the study was to try to address the correlation between the electrode location within the stn and the development of postoperative neuropsychological events after chronic stimulation. Eight pts experienced neuropsychological side effects. A man being treated with bilateral deep brain stimulation (dbs) for symptoms related to parkinsons disease experienced psychosis with violent behavior, jealousy and persecutory delusions 6 months after increasing the left-side amplitude to 3v. The pt was admitted to the psychiatric ward and the dbs device was deactivated. Mri showed the tip of the left electrode was located outside the stn boarder. Surgical revision of the electrode resulted in resolution of the pt's delusions for the next 3 yr follow-up period.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008139
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« Reply #88 on: January 13, 2014, 09:53:56 AM »

Model Number 3389
Device Problems Shock, electrical; Insulation degradation; Lead(s), breakage of; Replace
Event Date 01/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported on 10/22/07, that the pt had experienced a shocking or jolting sensation at the ins location when stimulation therapy was turned on; there had been loss of therapy benefit. The impedance measurements had been normal. The hcp was advised to run an exhaustive impedance test. System settings were: battery voltage 3. 75, therapy impedance 851ohms, current 52, case+, 0-, 3. 6v, pw 60 and rate 185. At follow up in 2007, the pt had reported a burning sensation at the ins location when stimulation therapy was turned on; there had been tingling detected "around the pocket site that radiates up to the shoulder but still receives therapy control. " the electrode impedance readings had been checked and all were deemed within normal range (exact values were not provided); two impedance readings had been identical. The hcp reported, reading multiple unipolar measurements with the same value; she indicated that reprogramming was not an option for the pt because "no other settings are effective for this pt. " system parameters were: 2+c, 3+c, 1014ohms, 15ma, and c+, 0- and device integrity had been deemed acceptable. It was advised to review bipolar combinations for an open circuit and to check for fluid in the connector area. On 02/07/2008, the pt reported that an x-ray had been obtained of the lead that revealed "the insulation was pulling away" and it was "sent back to analysis". The hcp reported on 02/22/2008, that x-ray exam from 2007, had detected a "broken electrode" and the pt had experienced a new symptom of pain. The rep provided that the right-sided pulse generator had been explanted in 2007, and the right-sided lead and extension products were replaced once a month later. Analysis of the pulse generator had found no anomaly detected; the product was functionally acceptable. The hcp had indicated that the extension would be returned for analysis; the right-sided lead and extension products have not been received for inspection and their current disposition is unk. There was no injury reported; the pt had recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1009807
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« Reply #89 on: January 13, 2014, 11:12:53 AM »

Model Number 3389
Device Problem Mislocation
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
Journal reference: d. Fontaine et al. "subthalamic nucleus stimulation using a fisher zd stereotactic frame mr-ct fusion guidance and preoperative orthogonal radiographs, in parkinsons disease" medicochirurgie 53 (2007) 463-469. The article described the method and results of a technique to implant electrodes in the stn for treatment of pts with idiopathic parkinson's disease. Sixty (60) pts with motor fluctuations and/or dopa-induced dyskinesia had the stn bilateral implantation surgery. Several complications were reported as noted below. Reportable event: one pt had insufficient post-operative results due to poor electrode placement. The pt was later reimplanted with success.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1014526
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« Reply #90 on: January 13, 2014, 11:13:40 AM »

Model Number 3389
Device Problem Migration of device or device component
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Journal reference: d. Fontaine et. Al. "subthalamic nucleus stimulation using a fisher zd stereotactic frame mr-ct fusion guidance and peroperative orthogonal radiographs, in parkinson disease" neurochirugie 53 (2007) 463-469. The article describes the method and results of a technique to implant electrodes in the stn for treatment of pts with idiopathic parkinson's disease. Sixty (60) pts with motor fluctuations and/or dopa-induced dyskinesia had the stn bilateral implantation surgery. Several complications were reported as noted below. Reportable event: one pts had insufficient post-operative results due to poor electrode placement caused by electrode displacement. The pt was later reimplanted with success.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1014501
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« Reply #91 on: January 14, 2014, 07:55:00 PM »

Model Number 3389
Device Problem Electrode(s), fracture of
Event Date 06/16/2008
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
In early 2008, patient underwent placement of crw stereotactic head frame, stereotactic mri, and stereotactic implantation of a left-sided deep brain stimulation (dbs) electrode. On approx five months later, patient underwent placement of crw stereotactic head frame, stereotactic mri, and stereotactic implantation of a right-sided deep brain stimulation electrode. At the completion of the same day surgery, the surgeon interrogated the patient's left-sided device and found an open circuit. A post-operative skull x-ray identified a break in the left electrode behind the left ear. The surgeon had not interrogated the left-sided device prior to frame placement, and was therefore not able to determine whether the break or fracture of the left-sided electrode had occurred prior to frame placement. The left-sided fractured dbs electrode was removed (and replaced) on two months later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1213924
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« Reply #92 on: January 14, 2014, 10:24:03 PM »

Model Number 7424
Device Problems Lead(s), breakage of; Replace
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Journal reference: schuurman pr, bosch da, merkus mp, speelman ld. Long-term follow-up of thalamic stimulation versus thalamotomy for tremor suppression. Mov disord, 2008;23(8 );1146-1153. Thalamic stimulation and thalamotomy for treatment of tremor due to parkinson's disease, essential tremor, and multiple sclerosis were compared in a randomized trial. The symptomatic and functional outcome was studied after 5 years of follow-up. Sixty-eight patients were treated (45 pd, 13 et, 10 ms) by thalamotomy (n = 34) or thalamic stimulation (n = 34). After 5 years, 48 patients were available for follow-up. Reportable event: one stimulation patient experienced electrode-fracture requiring second lead implantation. See mfg report 2182207200805826.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1162703
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« Reply #93 on: January 14, 2014, 11:21:35 PM »

Model Number 7424
Device Problem Implant, removal of
Event Type  Injury   Patient Outcome  Other,Required Intervention
Manufacturer Narrative
See scanned pages.

 
Event Description
Lind g, schechtmann g, lind c, winter j, meyerson ba, linderoth b. Subthalamic stimulation for essential tremor, short-and long-term results and critical target area. Stereotact funct neurosurg. 2008;86(4):253-258. In order to explore the usefulness and long-term results of subthalamic nucleus (stn) stimulation for the treatment of essential tremor (et), we evaluated 3 groups of patients undergoing deep brain stimulation (dbs) for et. Group 1 consisted of 3 patients who 9 years ago at intra-operative testing had good temor reduction from stn stimulation. The second group consisted of 10 patients treated with dbs in the ventral intermediate (vim) nucleus of the thalamus. The third group comprised 9 patients subjected to stn stimulation for et with 1-3 years of follow-up. Reportable event: group 2. One patient had had several battery replacements, and despite an increase in stimulation intensity, the tremor-blocking effect had diminished considerably. The electrode was eventually removed due to infection.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1162718
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« Reply #94 on: January 14, 2014, 11:22:38 PM »

Model Number 7426
Device Problems Dislodged; Replace
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Journal reference: merello m, tenca e, lloret sp, et al. Prospective randomized 1-year follow-up comparison of bilateral subthalamotomy versus bilateral subthalamic stimulation and the combination of both in parkinson's disease pts: a pilot study. Br j neurosurg. 2008;22(3):415-422. It has been suggested that potential risk of hemiballismus after subthalamotomy makes dbs preferable to ablation for ipd treatment; however, cost and the need for regular electrode control have also been observed as disadvantages to stimulation. The objective was to compare efficacy and safety of different surgical approaches to stn, in a prospective randomized pilot study. The 16 consecutive ipd pts randomized to receive either: bilateral stn-dbs (bs group), bilateral subthalamotomy (bl group), or unilateral subthalamotomy plus contralateral stn-dbs implantation (l/s group), and followed for 12 months after surgery. Reportable event: one pt from the combined technique group presented externalization of the electrode requiring replacement. See mfg report 2182207200805745.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161215
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« Reply #95 on: January 16, 2014, 04:58:32 AM »

Model Number 7428
Device Problems High impedance; Other (for use when an appropriate device code cannot be identified)
Event Date 10/08/2008
Event Type  Malfunction 
Manufacturer Narrative
In 2008, the lead was returned to the manufacturer for analysis which is not complete as of the date of this report. A follow-up report will be sent when the analysis is complete.

 
Event Description
When the lead cap was being removed, the lead cap nut backed out with the screw and lodged into the lead cap. The #0 electrode was frayed with the lead cap taken off. When tested at an amplitude of 3 volts, electrode impedances were greater than 4000 ohms on all bipolar pairs involving the #0 electrode. Current measurements were within normal limits in case-#1, case-#2, and case-#3 combinations, but less than 15 microamperes on all other bipolar combinations on the left lead. The lead remains in the patient. The patient outcome was reported as 'no injury, recovered without sequela. ' additional information has been requested. A follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1236983
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« Reply #96 on: January 16, 2014, 06:18:13 AM »

Model Number 7426
Device Problems Electrode(s), fracture of; Lead(s), breakage of; Replace
Event Type  Injury   Patient Outcome  Required Intervention

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1258804
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« Reply #97 on: January 16, 2014, 02:53:27 PM »

Model Number 7426
Device Problem Misplacement
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
 
Event Description
Journal reference: pilitsis jg, metman lv, toleikis jr, hughes le sani sb, bakay ra, factors involved in long-term efficacy of deep brain stimulation of the thalamus for essential tremor. J neurosurg. 2008;109(4):640-646. Although nucleus ventralis intermedius stimulation has been shown to be safe and efficacious in the treatment of essential tremor, there is a subset of patients who eventually lose benefit from their stimulation. Proposed causes for this phenomenon include tolerance, disease progression, and suboptimal location. The goal of this study was to assess the factors that may lead to both stimulation failure, and less satisfactory outcomes. Reportable event: five of 10 leads placed in the suboptimal outcomes group were noted to have movement of the dbs electrode on intraoperative fluoroscopy. See mfr report # 2182207-2008-08142.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1260078
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« Reply #98 on: January 17, 2014, 11:10:32 AM »

Model Number 7426
Device Problems Difficult to interrogate; Difficult to position; Replace
Event Date 10/29/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the distal portion of the patient's intracranial electrode was found heavily encased in scar during implant surgery to place the stimulator. With dissection of this electrode out of that scar, several of the wires between the third and fourth contacts from the exposed distal end were visible through the electrode tubing. This made placement of the lead into the lead extension connector more difficult, but the physician was able to make the connection. The remainder of the procedure was unremarkable. At follow up in 2008, the pt's device was interrogated and programmed by the mfr rep. The rep noted difficulties during the interrogation of the device but the pt indicated a clearly positive response from the programming. At follow up in the following month, it was noted that the patient had initially improved following activation of the device system. The patient had not experienced any "shut downs" since activation. However, the patient felt that he had lost some of his initial benefit, particularly with respect to handwriting, anxiety, urinary incontinence (secondary to difficulty mobilizing), as well as a fine tremor on his right side. The patient felt he had had some improvement but not as much as he had hoped. The patient experienced technical difficulty at the electrode lead extension interface. The patient returned to the operating room for replacement of his left deep brain stimulation electrode. The new electrode was placed without difficulty. The patient tolerated the procedure well and there were no complications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1289962
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« Reply #99 on: January 17, 2014, 12:18:36 PM »

Model Number 7426
Device Problems Component(s), broken; Dislodged; High impedance
Event Date 07/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the patient experienced a loss of therapeutic effect. X-rays showed that the connector on right side has descended and some damage to electrodes were visible. Impedances reading were >2000 ohms on all unipolar pairs. No further outcome was reported. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1283183
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« Reply #100 on: January 17, 2014, 07:17:33 PM »

Model Number 7426
Device Problems Dislodged; Replace
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the pt underwent revision of one of the dbs electrodes (left side). The electrode had backed out of the intended target (stn) by about 8 mm causing the pt to lose therapy benefit. The physician was unsure why the electrode had backed out. The burr hole cap and cover as well as the electrode looked ok. There was no fall or trauma reported. The physician removed the electrode and put in a replacement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1302493
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« Reply #101 on: January 17, 2014, 09:27:51 PM »

Model Number IPGNEURO
Device Problem Implant, removal of
Event Date 08/04/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: martin aj, larson ps, ostrem jl, starr pa. Interventional magnetic resonance guidance of deep brain stimulator implantation of parkinson disease. Top magn reson imaging. 2009;19(4):213-221. Summary: review the use of interventional magnetic resonance image guidance for the implantation of deep brain stimulator electrodes. The patient developed an infection associated with the extension wire connecting the ipg to the dbs electrode. This required complete removal of the electrodes. This patient was subsequently re-implanted.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353057
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« Reply #102 on: January 17, 2014, 09:28:28 PM »

Model Number IPGNEURO
Device Problem Implant, removal of
Event Date 10/10/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: mizukawa k, kondoh t, kohmura e. Intrathecal baclofen therapy in patients with ventriculoperitoneal shunt: a report of 3 cases. Jpn j neurosurg. 2008:17(10):794-798. Summary: review of 3 patients who have a ventriculoperitoneal shunt received intrathecal baclofen. It was reported that a head wound infection overtook a portion of the electrode and stimulation equipment. A ct scan performed shows a residual electrode for deep brain stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353060
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« Reply #103 on: January 17, 2014, 09:29:21 PM »

Model Number IPGNEURO
Device Problem Internal fixation, revision of
Event Date 03/01/2005
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: lee jy, han jh, kim hj jeon bs, kim dg, paek sh. Stn dbs of advanced parkinson's disease, experienced in a specialized monitoring unit with a prospective protocol. J korean neurosurg soc. 2008:44(1): 26-35. Summary: this study evaluated 42 patients from 2005 - 2006, to assess the short term outcome of stn stimulation for patients with advanced pd evaluated in a 24h monitoring unit for movement disorder. Patient suffered adverse effects after dbs surgery. Patient underwent re-operation to reposition the electrodes, which were too medially located near or in the red nucleus. It was confirmed by the fused image of pre- and post- operative mri taken at 6 months after stn dbs. Patient had not experienced any improvement of symptoms with dysarthia and gait difficulty. Also, his mri 5 months after surgery demonstrated that the dbs electrodes were positioned off the stns. The right sided symptoms of the patient were dramatically improved after the revision surgery. See manufacturer report number: 2182207200902211.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353062
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« Reply #104 on: January 17, 2014, 09:30:01 PM »

Model Number IPGNEURO
Device Problem Internal fixation, revision of
Event Date 03/01/2005
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
Event Description
Literature: lee jy, han jh, kim hj jeon bs, kim dg, paek sh. Stn dbs of advanced parkinson's disease experienced in a specialized monitoring unit with a prospective protocol. J korean neurosurg soc. 2008:44(1):26-35. E. Summary: this study evaluated a total patients from 2005 - early 2006 to assess the short term outcome of stn stimulation for patients with advanced pd evaluated in a 24h monitoring unit for movement disorder. Patient suffered adverse effects after dbs surgery. 3d ct scan of patient examined immediately after stn dbs demonstrated that an electrode targeted on the left stn was indwelled in the third ventricle. The patient underwent re-operation two days after the initial surgery to reposition the left electrode. See manufacturer report number: 2182207-2009-02211.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353074
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« Reply #105 on: January 17, 2014, 09:30:38 PM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 03/01/2005
Event Type  Injury   Patient Outcome  Other
Event Description
Literature: lee jy, han jh, km hj jeon bs, kim dg, paek sh. Stn dbs of advanced parkinson's disease experienced in a specialized monitoring unit with a prospective protocol. J korean neurosurg soc. 2008:44(1):26-35. Summary: this study evaluated 42 patients from 2005 - 2006 to assess the short term outcome of stn stimulation for patients with advanced pd evaluated in a 24h monitoring unit for movement disorder. Patient suffered adverse effects after dbs surgery. Immediate postoperative ct scans demonstrated a small intra-cranial hemorrhage (<1cm diameter) along the trajectory of the electrodes. Ich was symptomatic. See manufacturer report number: 2182207-2009-02211.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353077
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« Reply #106 on: January 17, 2014, 09:31:43 PM »

Model Number 7426
Device Problems High impedance; Implant, reprogramming of
Event Date 02/22/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
The patient experienced a loss of therapeutic effect. There were no falls of incidents related to the event. Impedances were checked and some of the electrodes were found to be >2000 ohms. Reprogramming was done which gave the patient some benefit, but then the patient was getting a tingling sensation down her leg. Further troubleshooting was being considered. Additional information has been requested, a follow-up report will be sent if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1387857
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« Reply #107 on: January 17, 2014, 09:33:10 PM »

Model Number 7426
Device Problem High impedance
Event Date 02/01/2009
Event Type  Injury 
Manufacturer Narrative
 
Event Description
The patient experienced pain at the deep brain stimulator pockets traveling up to the extension and lead to the burr hole site. The patient had a history of infection at the pocket, treated with antibiotics (see mfg. Report# 3004209178-2009-01727). The patient was confirmed to be allergic to silicone. Out of range impedances were noted in the left system on electrode combinations 0-2, 0-3 , and 1-3. No out of range impedances were noted on the right lead. Two custom polyurethane extensions were being prepared for the patient. Please see mfr. Report # 3004209178-2009-01728. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1343131
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« Reply #108 on: January 17, 2014, 10:10:44 PM »

Model Number 7428
Device Problem Implant, removal of
Event Date 10/16/2008
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
Manufacturer Narrative
See scanned pages.

 
Event Description
Literature: derrey s, maltete d, chastan n, et al. Deep brain stimulation of the subthalamic nucleus in parkinson's disease: usefulness of intraoperative radiological guidance the stereoplan. Stereotact funct. Neurosurg. 2008;86(6):351-358. One pt had sepsis which required the electrode's removal. Additional surgery was required after 6 months (reason not stated). See manufacturer report number: 2182207-2009-01097.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1314400
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« Reply #109 on: January 17, 2014, 10:11:36 PM »

Model Number 7424
Device Problem Unknown (for use when the device problem is not known)
Event Type  Death   Patient Outcome  Death
Event Description
Literature: ghika j et al. "postanoxic generalized dystonia improved by bilateral voa thalamic deep brain stimulation. " neurology. 2002. 56:311-313. A generalized dystonia patient with a history of drug use and suicide attempts began dbs treatment. Cognitive postoperative testing at 1 month showed no significant change. Because of marginal clinical improvement in the following 6 weeks, relocation of the electrodes in both voa nuclei of the ventrolateral thalamus was performed 6 weeks later. During the first 3 months, no significant changes were observed. At 4 months, the patient was able to stand unaided and could walk freely. Unfortunately, he committed suicide while still improving.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1324572
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« Reply #110 on: January 17, 2014, 10:12:22 PM »

Model Number 7428
Device Problem Replace
Event Date 10/16/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: derrey s, maltete d, chastan n, et al. Deep brain stimulation of the subthalamic nucleus in parkinson's disease: usefulness of intraoperative radiological guidance the stereoplan. Stereotact funct. Neurosurg. 2008;86(6):351-358. One pt had compressive pneumoencephaly which explained a left electrode deviation. This required a replacement of this electrode 6 months later. See manufacturer report number: 2182207-2009-01097.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1314398
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« Reply #111 on: January 17, 2014, 10:13:20 PM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 11/25/2008
Event Type  Injury 
Event Description
Literature: bhatia s, oh m, whiting t, quigley m, whiting d. Surgical complications of deep brain stimulation: a longitudinal single surgeon, single institution study. Stereotact funct neurosurg. 2008;86(6):367-372. Literature summary: this report analyzed the complications of a single surgeon at one institution over a 10-year period. A total of 191 pt received 330 electrodes implant. There were 59 complications in 53 of the 191 pt. Pt developed pneumonia after stage one of the procedure. See manufacturer report number: 2182207200901002.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1313848
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« Reply #112 on: January 18, 2014, 04:16:23 AM »

Model Number 7426
Device Problems High impedance; Implant, reprogramming of
Event Date 03/01/2009
Event Type  Injury 
Manufacturer Narrative
 
Event Description
The pt experienced a return of tremor. One month later, he was seen in clinic. Impedances on all bipolar electrode pairs involving electrode 2 were greater than 2000 ohms with a current of 7 microamperes. X-rays of the device system were taken; no fractures were seen. The deep brain stimulator was reprogrammed to use different electrodes for therapy. The amplitude was increased to 1. 5 volts. The pt experienced an immediate relief of symptoms, pt and device identifiers are not available. A follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1372421
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« Reply #113 on: January 18, 2014, 01:59:19 PM »

Model Number 7428
Device Problems High impedance; Implant, reprogramming of
Event Date 12/01/2008
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
The patient experienced a "big fall" around christmas time. Since then the patient had a loss of therapeutic effect; a decline in movement. They were uncertain if it was due to implantable neurostimulator or spinal cord compression. Therapy impedances were >4000 ohms. One electrode was showing >4000 ohms; the reporter didn't know which electrode was affected. The impedance testing was run up to 4. 0 volts. They programmed around the electrode that was bad and the patient was getting okay relief, but the electrode that was open was still showing open. They had run impedance at different times and since the last one they had gotten >1200, and >3000. Additional information has been requested, a follow-up report will be sent if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1466644
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« Reply #114 on: January 18, 2014, 02:00:09 PM »

Model Number IPGNEURO
Device Problem Device remains implanted
Event Date 03/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: gervais-bernard h, xie-brustolin j, mertens p, et al. Bilateral subthalamic nucleus stimulation in advanced parkinson's disease; five year follow-up. J neurol. 2009; 256(2): 225-233. Summary: this study assessed the long-term efficacy and safety or bilateral subthalamic nucleus (stn) stimulation in patients with advanced parkinson's disease (pd). A total consecutive patients with idiopathic pd treated with bilateral stn stimulation were enrolled from 1998 to 2002. It was reported that one pt required repositioning of one electrode because of a lack of efficacy or capsular side effects. This was performed within the first 6 months after the initial surgery. See manufacturer report number: 2182207200903228.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1378217
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« Reply #115 on: January 20, 2014, 05:12:27 AM »

Device Problem Malposition of device
Event Date 11/30/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: chan dtm, zhu xl, yeung jhm, et al. Complications of deep brain stimulation: a collective review. Asian j surg. 2009; 32(4): 258-63. Summary: this article presents an audit of all the patients implanted with deep brain stimulation (dbs) between 1997 to 2008 at one facility to assess complications arising from the 100 dbs electrode insertions and prevention of complications. Reportable event: two patients experienced electrode malposition. Both patients suffered intolerable stimulation side effects and underwent revision. No patient outcome was reported. See literature article with mfr report #3007566237-2009-09382.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566212
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« Reply #116 on: January 20, 2014, 01:10:42 PM »

Model Number IPGNEURO
Device Problem Implant, removal of
Event Date 02/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
See scanned pages.

 
Event Description
Literature: mehrkens jh, botzel k, steude u, et al. Long-term efficacy and safety of chronic globus pallidus internus stimulation in different types of primary dystonia. Stereotact funct neurosurg. 2009;87(1):8-17. Summary: this report describes a retrospective long-term analysis of 18 pts followed between 37 and 90 months suffering from dystonia. Pts had bilateral pallidal electrode implantation with permanent implantation of a stimulation system. Event: it was reported that the pt experienced a local infection at the burr hole necessitating the removal of the left deep brain stimulation electrode 14 days after the primary procedure. Re-implantation was performed 3 months later without complications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1423542
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« Reply #117 on: January 20, 2014, 01:11:46 PM »

Model Number 7428
Device Problem Lead(s), breakage of
Event Date 02/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
See scanned pages.

 
Event Description
Literature: blomstedt o, fytagoridis a, tisch s. Deep brain stimulation of the posterior subthalamic area in the treatment of tremor. Acta neurochir (wien). 2009; 151(1):31-36. Summary: this study examines five patients with tremor who were operated using unilateral deep brain stimulation of the posterior subthalamic area (psa). Patients were assessed before and 1 year after surgery and the results show the mean improvement on stimulation was 87% however, limited literature is available and sample size in the current study was small. Event: it was reported that the patient experienced electrode breakage and it was decided to replace it with a new electrode in the psa. Macro stimulation during surgery did not yield an optimal effect, and it was decided to implant a second electrode in the same location as the broken electrode in the ventralis intermedius (vim).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1423552
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« Reply #118 on: January 20, 2014, 02:02:27 PM »

Model Number 7428
Device Problems Other (for use when an appropriate device code cannot be identified); No Known Device Problem
Event Date 06/20/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: pinsker mo, volkmann j, falk d, et al, deep brain stimulation of the internal globus pallidus in dystonia; target localization under general anesthesia. Acta neurochir (wien), 2009; 151(7): 751-758. Summary: this article presents a single center experience of all consecutive operations on a total pts with general, focal or segmental dystonia undergoing dbs implantation with the target site in the globus pallidus intemus, all done under general anesthesia, using mri based stereotactic anatomical targeting, intra-operative mer, and test stimulation to determine electrical thresholds of adverse effects. Reportable event: in two pts, electrodes had to be removed temporarily, due to infection, but they were able to be re-implanted without sequela. Reference literature article attached to mfr report # 2182207200905483.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1441123
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« Reply #119 on: January 20, 2014, 02:37:07 PM »

Model Number 37612
Device Problems Electrode(s), fracture of; High impedance; Device operational issue
Event Date 07/21/2009
Event Type  Injury   Patient Outcome  Hospitalization,Other
Event Description
The patient experienced a lack of effect. The patient was hospitalized for treatment of pain, to perform a computerized tomography and to take x-rays. Device interrogation revealed high impedance readings for the right-sided device. X-rays revealed that one of the screws at the 'connection to the electrode' was slightly turned. An exploratory surgery of the connection was done in 2009. It was determined that the 'screw was stuck' and the electrode was broken between contact 2 and 3. The system was revised one week later. The lead and extensions were replaced. The device system with the new components was interrogated. Impedances greater than 4000 ohms were noted on one channel. The patient felt 'very well' after surgery. He had regained good therapeutic effects from spinal cord stimulation.

 
Manufacturer Narrative
The lead and extension have been returned to the manufacturer for analysis, which is not complete as of the date of this report. A follow-up report will be sent when the analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1462674
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« Reply #120 on: January 20, 2014, 03:02:42 PM »

Device Problem Malposition of device
Event Date 07/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
>.

 
Event Description
Literature: walker hc, watts rl, guthrie s, wang d, guthrie bl, bilateral effects of unilateral subthalamic deep brain stimulation on parkinson's disease at 1 year. Neurosurg. 2009; 65(2): 302-9. Summary: this article presents a prospective study that investigated the effects of unilateral stn dbs on motor function in 37 pts with moderate to advanced idiopathic parkinson's disease. The objective of the study was to quantify the benefit of unilateral dbs on contralateral, ipsilateral, and axial symptoms of advanced parkinson's disease. The pt's were evaluated "off" medication preoperatively (baseline), and then at 3, 6, and 12 months postoperatively. Reported event: one pt had poor electrode placement which required repeat surgery to reposition the lead. The pt did reach one-year follow-up. Additional info has been requested, but was no. T available as of the date of this report. Reference literature article attached to mfr report# 2182207200905822.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1447222
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« Reply #121 on: January 20, 2014, 10:25:35 PM »

Device Problem Migration of device or device component
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Hospitalization,Other
Manufacturer Narrative
 
Event Description
Stimulation effects from the left-sided electrode stopped. It was determined that the deep brain stimulation electrode was dislocated (date unk). The patient was hospitalized and the electrode was re-implanted. Afterwards, the patient's medications were adjusted. The investigator judged the event to probably be related to surgery and possibly related to the deep brain stimulation system. The event resolved completely in 2007. As a result of a review of our mdr procedure with fda, it was determined that events in clinical studies should have been reported with in a 30-day time frame. We are filing these late reports as directed by the staff.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1520178
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« Reply #122 on: January 20, 2014, 10:27:33 PM »

Model Number IPGNEURO
Device Problem Intermittent continuity
Event Date 01/01/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that since the device was replaced several months ago, the patient had been experiencing increased stimulation about 50 times per day. The patient stated it felt like the stimulation was going off and then on. The patient noted he was "a little dizzy". The logs noted no activations and impedances looked good at 486 ohms and current was 82, 1-, 2-, c+. One electrode was out of range, but not being used. The patient had device reprogrammed as contact 1 had previously been negative and was changed to contact 2 negative and increased the amplitude. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1516803
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« Reply #123 on: January 20, 2014, 10:29:18 PM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 02/16/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4). See manufacturer report number: 2182207200907584.

 
Event Description
Literature: o'sullivan d, pell m. Long-term follow-up of dbs of thalamus for tremor and stn for parkinson's disease. Brain res bull. 2009; 78(2-3): 119-121. Summary: dbs of the vim nucleus of the thalamus maintains long-term benefit for tremor due to essential tremor or to severe tremulous parkinson's disease. As far as bilateral stn stimulation, it maintains the benefit for the movement disorder aspect of parkinson's disease, such as tremor, rigidity and bradykinesia, but in the author's experience, does not prevent the progression of the disease and therefore is of no benefit for the non-dopaminegic aspects of the disease. Event: it was reported that the patient developed tolerance and response to stimulation failed over the follow-up period of 5 years. It was considered that the electrode had migrated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1516801
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« Reply #124 on: January 20, 2014, 10:31:10 PM »

Model Number IPGNEURO
Device Problems Disconnection; High impedance
Event Date 09/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the patient's left brain electrode was not providing any real benefit and very little in the way of stimulation induced adverse effects (no dysarthria and less paresthesia than would be expected) even with monopolar at three contacts up to around 7 volts with high pulse widths (210). Her right brain electrode was providing almost complete tremor control at 1. 7 volts. Impedances were high in 0 monopolar and 0+2, 0+3 but everything else appeared fine during operating test stimulation. Current impedace readings were >4000 ohms x-rays revealed that the left lead had disconnected from the extension. The patient was scheduled for a revision in 2009. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1516345
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« Reply #125 on: January 22, 2014, 02:35:49 AM »

Device Problem Fracture
Event Date 12/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: maldonado il, roujeau t, cif l, et al. Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage. Neurosurg. 2009;6(supp s):196-201. Summary: this article present a retrospective study of all deep brain stimulation (dbs) electrode implants at a given institution between 1996 and 2007. The records were retrieved from a computerized database. A total of 478 electrodes were implanted in 220 consecutive procedures were performed in 194 pts. The aim of the study was to determine the safety of dbs technique consisting of a combination of routine general anesthesia, magnetic resonance imaging direct targeting, and a single penetration technique in a large population of pts undergoing implant secondary to movement disorders. No microelectrode recording or intraoperative stimulation was performed. Reportable event: three pts underwent electrode replacement due to rupture. Reference mfr report #3007566237201001308.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617912
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« Reply #126 on: January 22, 2014, 02:36:25 AM »

Device Problem Device operational issue
Event Date 12/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: maldonado il, roujeau t, cif l, et al. Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage. Neurosurg. 2009; 6 (supp s): 196-201. Summary: this article presents a retrospective study of all deep brain stimulation (dbs) electrode implants at a given institution between 1996 and 2007. The records were retrieved from a computerized database. A total of 478 electrodes were implanted in 220 consecutive procedures were performed in 194 pts. The aim of the study was to determine the safety of dbs technique consisting of a combination of routine general anesthesia, magnetic resonance imaging direct targeting, and a single penetration technique in a large population of pts undergoing implant secondary to movement disorders. No microelectrode recording or intraoperative stimulation was performed. Reportable event: four pts underwent electrode replacement due to lead malfunction without proven rupture. Reference mfr report #3007566237201001317.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617921
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« Reply #127 on: January 22, 2014, 02:36:53 AM »

Device Problem No Known Device Problem
Event Date 12/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: maldonado il, roujeau t, cif l, et al. Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage. Neurosurg, 2009;6(supp s):196-201. Summary: this article presents a retrospective study of all deep brain stimulation (dbs) electrode implants at a given institution between 1996 and 2007. The records were retrieved from a computerized database. A total of 478 electrodes were implanted in 220 consecutive procedures were performed in 194 pts. The aim of the study was to determine the safety of dbs technique consisting of a combination of routine general anesthesia, magnetic resonance imaging direct targeting, and a single penetration technique in a large population of pts undergoing implant secondary to movement disorders. No microelectrode recording or intraoperative stimulation was performed. Reportable event: two pts underwent electrode replacement due to infection. Reference mfr report#3007566237-2010-01234.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617814
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« Reply #128 on: January 22, 2014, 07:30:36 AM »

Model Number 7426
Device Problem No Information
Event Date 05/01/2003
Event Type  Malfunction 
Event Description
It was reported by the hcp, 'there was attempt at revision in (b) (6) 2003 because of problems with the electrodes, but because of difficulty with the hardware, the revision was not done. " no symptoms or outcome were reported. Additional info has been requested; a follow-up report will be submitted if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1639314
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« Reply #129 on: January 22, 2014, 07:31:54 AM »

Device Problem Migration of device or device component
Event Date 01/14/2010
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: lee j-y, jeon bs, paek sh, lim yh, kim m-r, kim c. Reprogramming guided by the fused images of mri and ct in subthalamic nucleus stimulation in parkinson's disease. Clin neurol neurosurg. 2010; 112(1): 47-53. Summary: this article presents a study of 65 pts with parkinson's disease who underwent bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) between march 2005 and september 2006 and had been managed for at least 6 months within conventional programming based on physiological responses. The aim of the study was to evaluate the usefulness of a visual info about the location of the contacts in dbs programming, and compare the outcome of stn before and after reprogramming guided by the fused image of mri and ct. Reportable event: some pts appeared to have a significant shift in the location of the electrodes between the immediate and 6-month post-operative ct. The shift moved in the ventral direction. The shift was felt to be partly due to csf leakage during the operation. No pt treatment or outcome was reported. Reference mfr report #3007566237201001755. See literature article attached to mfr report# 3007566237201001696.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1628499
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« Reply #130 on: January 22, 2014, 09:12:42 AM »

Device Problems Premature discharge of battery; Communication or transmission issue; Electrical shorting
Event Date 10/01/2009
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
(b) (4).

 
Event Description
The pt experienced a loss of therapy efficacy. Approx 3 weeks later, the pt was seen in clinic. No telemetry could be established between the deep brain stimulator and the physician programmer. It was determined that there was a short in one of the electrode combinations. This combination was inadvertently programmed to be used in therapy, causing premature deep brain stimulator battery depletion. The neurostimulator was replaced. Afterward, the pt's therapy resumed to a satisfactory level.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614500
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« Reply #131 on: January 22, 2014, 09:13:16 AM »

Device Problem Migration of device or device component
Event Date 12/31/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: york mk, wilde ea, simpson r, jankovic j. Relationship between neuropsychological outcome and dbs surgical trajectory and electrode location. J neurol sci. 2009; 287(1-2): 159-171. Summary: this article presents a study of an standardized eval of the location of the deep brain stimulation (dbs) electrode tip and the active electrodes, the surgical trajectory through which they were placed, and their relation to neuropsychological change scores in 17 pts implanted with bilateral subthalamic nucleus (stn) dbs using 6 month post-surgical magnetic resonance imaging data. Reportable event: one pt's left electrode migrated outside the radiologically defined stn. The pt did not receive good motor benefit following surgery. The left stimulation was eventually turned off following the mri results. The pt elected not to have a revision of the dbs electrode.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1586065
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« Reply #132 on: January 23, 2014, 07:34:21 AM »

Model Number 7426
Device Problem Malposition of device
Event Date 02/28/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: moro e, hamani c, poon yy, et al. Unilateral pedunculopontine stimulation improves falls in parkinson's disease. Brain. Jan; 133 (pt 1): 215-224. Summary: this was an evaluation of ppn dbs in six patients with intra-operative neurophysiological and postoperative imaging characterization of the surgical target. The aim of this prospective study was to investigate the safety and the effects of unilateral ppn dbs on motor signs, especially falls, freezing of gait and postural stability in patients with advanced parkinson's disease. Event: one patient had the electrode repositioned 4 months after the initial implant due to very low threshold of stimulation-induced paresthesias and the lack of any motor improvement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1658303
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« Reply #133 on: January 23, 2014, 07:35:38 AM »

Model Number LEADMVD
Device Problem Positioning Issue
Event Date 02/28/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: xiaowu h, xiufeng j, xiaoping z, et al. Risks of intracranial hemorrhage in patients with parkinson's disease receiving deep brain stimulation and ablation. Parkinsonism relat disord. Feb; 16(2): 96-100. Summary: the study analyzed risk factors (patient age, sex, blood pressure, anatomical targets, number of microelectrode recording penetrations and surgical modality) for hemorrhage in a large series of deep brain stimulation (dbs) and ablation procedures in patients with advanced parkinson's disease (pd). Event: dbs electrodes were placed. In 87 patients who did not undergo microelectrode recording (mer), the target position was confirmed by intraoperative mri scan with a stereotactic frame. The actual target was modified in 21 cases in subsequent procedures; 19 of which were adjusted by 2. 0 - 3. 5 mm in depth.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656252
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« Reply #134 on: January 23, 2014, 08:54:01 AM »

Device Problems Break; Material twisted
Event Date 02/28/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: gelabert-gonzalez m, relova-quinteiro jl, castro-garcia a. "twiddler syndrome" in two patients with deep brain stimulation. Acta neurochir (wien). Mar; 152(3): 489-491. Summary: this article reviews the clinical cases of two patients with parkinson's disease who had subthalmic bilateral electrodes implanted and presented with twiddler syndrome 2 and 3 years after surgery. Event: the patient is a (b) (6) woman with a 12 year history of parkinsons disease, treated with levodopa and amantadine. The patient was admitted in (b) (6) 2005. Quadripolar dbs electrodes were implanted in each stn and a pulse generator was implanted in the abdominal wall 2 days later and sutured to the fascial plane. Following good clinical recovery, the 1 year follow up period showed an important reduction of symptoms. Two years later, the patient presented with a disabling tremor and increased rigidity on the right side of the body. Radiographs of the stimulation system showed the left electrode was fractured at the neck, and the extensions wires were intertwined from the neck to the abdominal bag. The patient reported having twisted the generator box because "it didn't feel right. " surgery was performed to replace the left electrode. Postoperative outcome was uneventful and the patient was discharged 6 days later. It was also noted the patient had no psychiatric disorder, however, they admitted they had often manipulated the generator in the abdominal sack without perceiving any discomfort. See literature article attached to mfr report # 3007566237201002832.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656253
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« Reply #135 on: January 23, 2014, 09:12:06 AM »

Model Number LEAD
Device Problems Difficult to position; Device operational issue
Event Date 03/31/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Literature: fytagoridis a, blomstedt p. Complications and side effects of deep brain stimulation in the posterior subthalamic area. Stereotact funct neurosurg. 2010;88(2):88-93. Summary: forty consecutive patients (67% men) operated with dbs in the posterior subthalamic area (psa) were analyzed for complications and side effects of the procedure. Twenty-seven patients had essential tremor, 8 had parkinson's disease, 2 had dystonic tremor, 1 had cerebellar tremor, 1 had neuropathic tremor and 1 writer's cramp. The mean age at surgery was ((b) (6)). The pts were followed for a mean time of 34 months (range 3-59). All procedures were performed by one surgeon during the period 2004-2008. Fifty-four dbs leads were implanted in these 40 patients, requiring a total of 57 tracks. Twenty-nine patients were operated in the left hemisphere, 7 in the right and 4 bilaterally. Four patients received an extra ipsilateral electrode in the psa due to an ambiguous response during perioperative stimulation of the original electrode. The pts were hospitalized for a mean of 7. 4 days (range 2-15). Reportable events: one procedure was aborted in the operation theatre and completed at a later occasion because the durotomy provoked a generalized seizure. One procedure was aborted in the operation theatre and completed at a later occasion due to suboptimal placement of the electrode in a pt too exhausted to allow a relocation of the electrode in the same session. Revision of the extension cables was performed in 2 patients due to straining and a feeling of tightness. One pt had an irritating granuloma removed from the infraclavicular scar. The implantable pulse generator malfunctioned in 1 patient with 2 ipsilateral electrodes. This problem was related to the stn electrode, and the clinical result was not affected. The source literature indicated the dbs lead models used were either 3387 or 3389, the electrodes were secured with a stimloc bur hole cover, extension models were not indicated, and the ipg model was 7428 (kinetra) in 37 of the 40 patients and model 7426 (soletra) in 3 of the 40 cases. The individuals and models for each event are unk.

 
Manufacturer Narrative
(b) (4). It was not possible to ascertain specific device info from the article. It is also possible several events occurred in one patient. At this time, no additional information was available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1676374
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« Reply #136 on: January 23, 2014, 09:46:54 AM »

Model Number 37601
Device Problem Radiofrequency interference (RFI)
Event Type  Malfunction 
Event Description
Medtronic employee reports changes to device programming due to environmental issues. Pt came into the hospital with his device turned off and an additional negative electrode was added. Device was turned back on and reset. Then he had a new lowrad digital format x-ray for another medical condition and device was found to be turned off and rate had changed from 60 to 30. The physician surmises that the wireless capability is what is changing the settings in this instances.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1693661
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« Reply #137 on: January 23, 2014, 09:47:26 AM »

Model Number IPGNEURO
Device Problem Bent
Event Date 01/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The electrode tip was curved. It was explanted. Add'l info has been requested. A f/u report will be submitted if add'l info becomes available.

 
Manufacturer Narrative
(b) (4). The lead was returned to the mfr for analysis which is not complete as of the date of this report. A f/u report will be sent when the analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1676369
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« Reply #138 on: January 23, 2014, 09:48:54 AM »

Model Number IPG
Device Problem No Known Device Problem
Event Date 03/01/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: fytagoridis a, blomstedt p. Complications and side effects of deep brain stimulation in the posterior subthalamic area. Stereotact funct neurosurg. 2010;88(2):88-93. Summary: forty consecutive patients (67% men) operated with dbs in the posterior subthalamic area (psa) were analyzed for complications and side effects of the procedure. Twenty-seven patients had essential tremor, 8 had parkinson's disease, 2 had dystonic tremor, 1 had cerebellar tremor, 1 had neuropathic tremor and 1 writer's cramp. The mean age at surgery was (b) (6). The pts were followed for a mean time of 34 months (range 3-59). All procedures were performed by one surgeon during the period 2004-2008. Fifty-four dbs leads were implanted in these 40 patients, requiring a total of 57 tracks. Twenty-nine patients were operated in the left hemisphere, 7 in the right and 4 bilaterally. Four patients received an extra ipsilateral electrode in the psa due to an ambiguous response during perioperative stimulation of the original electrode. The pts were hospitalized for a mean of 7. 4 days (range 2-15). Event: one pt with pd and bilateral implants suffered a postoperative infection. Three days after surgery he developed fever, elevated c-reactive protein, mild intermittent confusion and a discrete left-sided hemiparesis. Signs of inflammation were seen along the right cerebral electrode. The electrode was removed, and samples for bacteriological culture were collected. The cultures were negative and the pt was treated presumptively with antibiotics, and had recovered fully within 1 month. However, after 3 months, the scar over the left electrode became purulent. The second electrode was removed and cultures demonstrated growth of coagulase-negative staphylococcus aureus, enterobacter aerogenes and alpha-hemolytic streptococcus. This pt did not suffer any permanent sequelae.

 
Manufacturer Narrative
 
Event Description
Additional information from another literature article by the author revealed the following additional details regarding this event: literature: blomstedt, p. , bjartmarz, h. Intracerebral infections as a complication of deep brain stimulation. Stereotactic and functional neurosurgery. 2012;90:92-96. The patient, a (b)(6) male with parkinson's disease (pd), had been operated with left-sided vim dbs 7 years before. Due to suboptimal treatment results and disease progression, it was decided to replace the electrode with bilateral electrodes in the zona incerta. The old electrode, which was found to be broken, was removed 2 days before the procedure to facilitate mri. A ct on postoperative day 5 demonstrated an edema around the right electrode, with progression on the following day and a contrast-enhanced area around the edema. Furthermore, similar changes but to a lesser extent were noted around the left electrode. These changes were interpreted as cerebritis with developing abscess. The patient was initially treated with intravenous (vancocin and meronem) and later with oral antibiotics for 8 weeks. Twenty days after the operation, ct demonstrated apparent amelioration of intracerebral changes and recovery of the patient. An mri did however reveal remaining edema on the right side, especially around the tip of the electrode. For this reason, the right electrode was removed. Bacterial culture from the electrode demonstrated growth of (b)(6). Eleven weeks after the initial operation and 3 weeks after discontinuation of antibiotic treatment, the patient presented with headache, vertigo and later rupture of the cranial incision above the entry of the electrode with pus. The patient recovered without any permanent sequelae. This additional information was found in an article also reported in the follow reports, please access these reports for the full article: 3007566237-2012-00962 3007566237-2012-00963 3007566237-2012-00968.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1676370
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« Reply #139 on: January 23, 2014, 10:08:52 AM »

Model Number 3387
Device Problems High impedance; Device operates differently than expected
Event Date 04/01/2010
Event Type  Malfunction 
Event Description
The doctor had a difficult time tunneling during a stage 2 which resulted in stripping the silicone cover off the electrodes. The electrode looked okay, so it was covered with a boot. Impedance measurements for electrode #7 appeared to be greater than 4,000 ohms. The doctor opted to finish the implant since it was still going to be very functional for the pt. Additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1702366
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« Reply #140 on: January 23, 2014, 10:10:10 AM »

Model Number 7424
Device Problem Fracture
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: dilorenzo dj, jankovic j, simpson rk, takei h, powell sz, long-term deep brain stimulation for essential tremor: 12-year clinicopathologic follow-up. Mov disord. 2010;25(2):232-238. Summary: this article describes the clinical course and postmortem pathological finding in a patient with et treated with dbs for 12 years. This (b) (6) woman had a 13 year history of progressive et prior to implantation of bilateral dbs electrodes in the region of her vim thalamic nuclei in 1996, producing immediate relief of arm tremor. Histopathological examination of the brain, performed 12 years after the initial implantation, demonstrated electrode catheter tracts rimmed by 20-25 micron sheath, with multinucleated giant cells and reactive gliosis. Lymphocytic infiltration was seen by l26 immunoreactivity with cd3 (t cells) staining predominating over cd20 (b cells). Cerebellar axonal spheroids and purkinje cell loss were found. The minimal foreign body reaction and gliosis around the electrodes 12 years after implantation supports the long-term safety of dbs. Reportable event: the left vim intracranial electrode fractured at 15 months after initial implantation and was replaced 2 months later. The fracture occurred in the intracranial portion of the lead, 2. 8 cm from the proximal end and involved all four conductor wires. The patient otherwise experienced excellent control of her et bilaterally except during this period of temporary hardware failure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1692635
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« Reply #141 on: January 23, 2014, 10:11:32 AM »

Model Number 7424
Device Problem High impedance
Event Date 01/01/2008
Event Type  Death   Patient Outcome  Death,Hospitalization
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: dilorenzo dj, jankovic j, simpson rk, takei h, powell sz, long-term deep brain stimulation for essential tremor: 12-year clinicopathologic f/u. Mov disord. 2010;25(2):232-238. Summary: this article describes the clinical course and postmortem pathological finding in a pt with et treated with dbs for 12 years. This (b) (6) woman had a 13 year history of progressive et prior to implantation of bilateral dbs electrodes in the region of her vim thalamic nuclei in 1996, producing immediate relief of arm tremor. Histopathological examination of the brain, performed 12 years after the initial implantation, demonstrated electrode catheter tracts rimmed by 20-25 micron sheath, with multinucleated giant cells and reactive gliosis. Lymphocytic infiltration was seen by l26 immunoreactivity with cd3 (t cells) staining predominating over cd20 (b cells). Cerebellar axonal spheroids and purkinje cell loss were found. The minimal foreign body reaction and gliosis around the electrodes 12 years after implantation supports the long-term safety of dbs. Event: the pt's most recent stimulation parameter adjustment was on (b) (6) 2008. The right side impedance values were normal. Left side impedance values were >2000, >2000, 1,400, and 1,834 ohms with respect to the case, respectively, for electrodes 0 to 3. From these last measurements, left electrodes 0 and 1 may have been fractured. Although, the pt's tremor amplitude was at least 75% lower with the dbs turned on compared to that with the dbs off, she developed postural instability which confined her to a wheelchair. In (b) (6) 2008, she was admitted for physical therapy for muscle disuse atrophy, but was discharged after 6 weeks with minimal improvement. She died in her sleep on (b) (6) 2008.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1692688
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« Reply #142 on: January 25, 2014, 03:28:51 PM »

Model Number 7426
Device Problems Premature discharge of battery; Fracture; High impedance
Event Date 06/17/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
See manufacturer # 9614453201006593. On (b)(6)2010, the voltages were increased up to 2. 0v without any problems. A problem occurred on (b)(6)2010, upon interrogation. The right side was increased until 2. 2v with no clinical problems. The physician programmer showed a battery usage of 72%. The left side was then increased up to 2. 2v with no problems. The right side was then checked again for usage, and the pt suddenly reacted heavily with acute crying and made it clear he had suddenly experienced severe pain in the abdominal region. The parameters were left unchanged. There were increased impedances on the right side. An x-ray revealed either a fracture or disconnection in the insulation of the left electrode. The neurostimulators (ins) and extensions were explanted. The right ins was suspected of premature battery depletion and pocket stimulation. Upon explant, the right extension did not look normal. There was a disconnection within the insulation. Postoperatively the pt was started with intensive physiotherapy, which the child had never had before. There was an affect in both arms. It was unk if it was related to the device explant or the physiotherapy. No further pt complications were reported.

 
Manufacturer Narrative
(b)(4): analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1824448
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« Reply #143 on: January 25, 2014, 03:29:18 PM »

Model Number 7428
Device Problem Device operational issue
Event Date 07/01/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that electrode 6 was "out of range" on the pt's device. Add'l info was requested.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1824900
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« Reply #144 on: January 25, 2014, 03:30:20 PM »

Model Number 7428
Device Problem High impedance
Event Date 07/13/2010
Event Type  Injury 
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that just after implant, high impedances were measured (>4000 ohms) between electrode 0 and electrode 1. The pt needs both electrodes for successful therapy so that no successful stimulation was possible. The physician will wait four to six weeks and if impedances are still > 4000 ohms, replacement will be considered. Additional information has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1801180
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« Reply #145 on: January 25, 2014, 03:30:52 PM »

Model Number 3387
Device Problems Fracture; Kinked
Event Date 06/07/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4). Analysis results were not available at the time of this report. A f/u report will be sent when the analysis is completed.

 
Event Description
The lead appeared flimsy at implant. When the surgeon put the lead cap on, it destroyed the electrode. The end of the lead "where metal pieces are" looked bent. The end portion of the lead broke off and it was trimmed. The lead was implanted. There was no pt injury and pt recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1750610
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« Reply #146 on: January 25, 2014, 03:31:40 PM »

Model Number 7426
Device Problems Kinked; Impedance issue; Positioning Issue
Event Date 08/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4): the device has been returned to the mfr for analysis which is not complete as of the date of this report. A f/u report will be sent when the analysis is complete.

 
Event Description
It was reported lead was explanted due to infection. It was later reported lead was damaged during re-implant. The electrode was damaged while inserting lead through stim loc burr hole cover. The lead was kinked or crimped after insertion and impedances were abnormal. Physician indicated this resulted from sequence of surgical technique and not a faulty electrode. All impedance readings displayed as short circuits. Physician replaced the 1st lead with a new one. The new lead was connected to the current extension and battery. All of the impedances tested within the normal range. The pt's system will be programmed in the next few weeks. There was no pt injury and pt recovered w/o sequela. Add'l info will be provided when it becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1850865
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« Reply #147 on: January 25, 2014, 03:32:08 PM »

Model Number 37601
Device Problem Break
Event Date 08/23/2010
Event Type  Malfunction 
Event Description
It was reported that the carrier broke in the pt's neck and they had to make another incision. When removing the extension, the electrode was destroyed. Different extensions were used and everything was ok after that. Part of the carrier was saved. The pt was stitched up and surgery was completed. The pt's status was not known.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1841861
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« Reply #148 on: January 25, 2014, 03:32:38 PM »

Model Number 7428
Device Problem Failure to conduct
Event Date 07/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient's ins was explanted and replaced due to a current leak on the 6/8 electrodes. The patient had a reoccurrence of the previous (treated) symptoms. The patient's outcome was listed as "ok. " no further details or patient symptoms were provided at the time of this report. A follow-up report will be filed if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1834855
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« Reply #149 on: January 26, 2014, 01:48:05 AM »

Model Number IPGNEURO
Device Problem No Information
Event Date 09/28/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported patient had deep brain stimulation (dbs) system in 2004 and changed to implantable pulse generator (ipg) in (b)(6) 2008. According to patient, "the incision on the left side head occurred purulence about a month ago". When he returned to the hospital for programming, physician identified it as infected. After communicating between patient and company, physician decided to remove the infected electrode. The surgery was planned for (b)(6) 2010. The lead was explanted. At the time of this report, no further details were reported. Add'l info was requested and will be provided when it becomes available.

 
Manufacturer Narrative
(b)(4): analysis results were not available at the time of this report. A f/u report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885205
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« Reply #150 on: January 26, 2014, 02:04:41 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/11/2010
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. At this time, no additional info was available, additional info has been requested.

Event Description
Literature: blomstedt p, sandvik u, tisch s. Deep brain stimulation in the posterior subthalamic area in the treatment of essential tremor. Mov disord. Jul 30 2010; 25(10); 1350-1356. Summary: to evaluate the posterior subthalamic area (psa) as a target for deep brain stimulation (dbs) in the treatment of essential tremor (et). Twenty-one pts with et were included in this study from 2004-2007. The group consisted of seven women and 14 men; with a mean age of (b)(6) years. All pts were evaluated before and 1 year after surgery. Dbs in the psa resulted in a marked reduction of tremor. A marked microlesional effect was noticed in 83% of the pts on introduction of the electrode, and due to continued absence of tremor, the stimulation did not need to be started in 35% before discharge from the hospital. No pt had simultaneous stimulation of two ipsilateral electrodes. No severe or permanent complication occurred. No hemorrhages or infections were encountered in this series. Reportable event: four pts experienced mild dysphasia that regressed. These four received an additional ipsilateral electrode (two stn, one vim, and one psa) in the psa due to suspected sub-optimal positioning of the first electrode.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1888957
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« Reply #151 on: January 26, 2014, 02:05:59 AM »

Model Number IPGNEURO
Device Problem Positioning Issue
Event Date 05/04/2010
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time, no additional info was available, additional info has been requested.

Event Description
Literature: capelle hh, blahak c, schrader c, et al. Chronic deep brain stimulation in pts with tardive dystonia without a history of major psychosis. Mov disord. Jul 30 2010; 25(10):1477-1481. Summary: four women with tardive dystonia (secondary to neuroleptic medication) without a history of major psychosis underwent bilateral pallidal dbs in this observational study. Their tardive dystonia occurred more than 6 months after exposure to the neuroleptic medication. All pts had preoperative mr scans; all experienced sustained statistically significant benefit from pallidal dbs and there were no surgically related complications. Reportable event: pt 4 had unilateral stimulation; the electrode on the other side was not activated as it had been misplaced. As unilateral stimulation did not result in sustained improvement over the years, the pt was scheduled for revision of the misplaced electrode and then enrolled in this study.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1879532
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« Reply #152 on: January 26, 2014, 02:07:05 AM »

Model Number 7428
Device Problem No Known Device Problem
Event Date 05/12/2010
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4) - obtundation. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. The pt information provided is the average for all the pts. At this time no additional information was available, additional information has been requested.

Event Description
Literature: yoshida f, martinez-torres i, pogosyan a, et al. Value of subthalamic nucleus local field potentials recordings in predicting stimulation parameters for deep brain stimulation in parkinson's disease. J neurol neurosurg psychiatry. Aug 2010; 81(8 ): 885-889. Summary: the authors indicated that online spectral analysis of local field potentials (lfp) recorded from the deep brain stimulation (dbs) electrode may help identify the optimal therapeutic target in the subthalamic nucleus (stn) region for dbs in pts with parkinson's disease. A total of 31 pts participated; all except one pt was implanted bilaterally. The mean age of the participants was 57 years and there were 17 males. Clinical assessment of the efficacy of chronic dbs could not be performed in two of the 31 pts. Reportable event: this report is for one pt in the group of 31 who developed unexplained obtundation postoperatively; the dbs electrodes were therefore removed in the immediate postoperative period.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1884617
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« Reply #153 on: January 26, 2014, 02:08:46 AM »

Model Number 7428
Device Problem No Known Device Problem
Event Date 03/26/2010
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time, no additional information was available, additional information has been requested.

Event Description
Literature: xie j, adamec d, decullier e, et al. Do the effects measured by intraoperative and postoperative stn macrostimulation in parkinson's disease match? j neurol. Sep 2010;257(9):1453-1456. Summary: the aim of our study was to compare the results from 2000 to 2007 obtained by intraoperative and postoperative subthalamic nucleus (stn) macrostimulation in parkinsons' disease (pd). One hundred three pd patients implanted with bilateral stn stimulation were included; the side effects studied were divided into motor contraction, parasthesias and oculomotor sign. Mean age was 61. 2 years and mean disease duration was 15. 6 years. The authors observed small discordance between the intraoperative and postoperative evaluation. Side effects had severe consequences in three patients, in whom the electrodes had to be replaced because of low threshold side effects. Side effects in the other cases were obtained when very high intensity of stimulation was applied (that was not used chronically) or when sub-optimum contacts were used. Reportable event: this report is for patient 2 of 3 that required electrode replacement due to low threshold side effects.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1878190
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« Reply #154 on: January 28, 2014, 09:27:36 AM »

Model Number 3391
Device Problem Bent
Event Date 11/19/2010
Event Type  Malfunction  
Event Description
Upon opening the package in the operating room, it was observed that the area involving the first electrode contact was curved. Another lead was used for the procedure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1932043
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« Reply #155 on: January 28, 2014, 09:29:22 AM »

Model Number 3389
Device Problem Folded
Event Date 11/22/2010
Event Type  Malfunction  
Event Description
Received info that while unpacking an electrode during surgery the physician saw it was bent inside the package. When he took the electrode out of the package to look more closely he saw the distal end of the electrode was completely bent and could not be used for introduction into the brain. The physician decided to use another electrode. The new one was okay. The pt incurred no injury from this event.

Manufacturer Narrative
(b)(4). Analysis results were not available at the time of this report. A f/u report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1937764
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« Reply #156 on: January 28, 2014, 09:30:28 AM »

Model Number LEADMVD
Device Problem No Information
Event Date 11/09/2010
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Received info reporting the electrode for the right hemisphere was misplaced and position of the lead needed to be corrected. Additional info has been requested and if received a follow up report will be sent.

Manufacturer Narrative
(b)(4). This report is being submitted late due to a delay by a manufacturer employee. Training is in place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936209
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« Reply #157 on: February 07, 2014, 07:49:14 AM »

Model Number 37601
Event Date 10/21/2013
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_unknown_lead, lot# unknown, product type: lead. (b)(4). No device analysis was performed; the device met risk based criteria.

Event Description
It was reported the stimulator and electrodes were infected. It was also noted there were multiple infections after the electrodes and stimulator were implanted. Action taken as a result of the event was noted as invasive intervention. Additional information has been requested but was not available as of the date of this report; a follow-up report will be sent if information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3578750
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« Reply #158 on: May 11, 2014, 05:58:24 PM »

Model Number 7428
Event Type Injury
Patient Outcome Required Intervention,Hospitalization
Manufacturer Narrative
Product id neu_unknown_ext, serial# unknown; product type extension product id neu_ unknown_lead, lot# unknown; product type lead. (b)(4).

Event Description
It was reported the patient experienced less than 50% therapy relief at both their left and right side implants. It was stated impedance testing found impedances greater than 4000 ohms on all electrodes, except electrode 1. It was noted, the patient required hospitalization due to the event and that they were alive with no injury at the time of report. Additional information reported an x-ray had been taken. It was further reported ¿there was a break in the extension near¿ the implantable neurostimulator (ins) and the ¿patient would get a new extension. ¿ further information has been requested. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3739661
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« Reply #159 on: May 11, 2014, 08:35:04 PM »

Model Number 37603
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported a deep brain stimulator (dbs) lead was removed for complaints of dysarthria and the magnetic resonance image (mri) found a cystic structure at the electrode tip. It was noted the brain electrode was removed with no adverse sequelae. It was noted the patient¿s speech had improved and their dystonia was still treated by the contralateral electrode.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # va00ucg, implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3725131
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« Reply #160 on: May 11, 2014, 08:36:07 PM »

Model Number 37601
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported when the health care professional started to program the patient after their implant, one of the wires did not work so they had to ¿cut it off. ¿ it was noted at the implantable neurostimulator (ins) site there was a wire that stuck out of the patient¿s chest. It was stated it had healed over. It was noted the patient had stimulation on both sides of their body and therefore it was ¿likely that one of the electrodes did not work rather than the entire lead. ¿ additional information received reported the patient¿s surgical incisions were examined and there was no lead protruding. It was stated all incisions were well-healed. It was noted the cause of the issue was not determined. It was stated the patient was re-programmed.

Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # va0cnv2, implanted: (b)(6) 2013, product type lead; product id 3389s-40, lot # va0bnyf, implanted: (b)(6) 2013, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 3389s-40, lot # va0bnyf, implanted: (b)(6) 2013, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3736519
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« Reply #161 on: June 07, 2014, 10:48:53 AM »

Model Number 37612
Event Date 02/20/2014
Event Type Injury
Patient Outcome Hospitalization
Manufacturer Narrative
(b)(4).

Event Description
It was reported that there were 1-2 bad electrodes isolated to one side of a bilateral deep brain stimulation (dbs) system. The patient was recharging often and there was high current drain with low impedance. The manufacturer¿s representative had met with the patient the day prior to report to perform impedance testing. Electrode impedances were as follows: c/0 745, c/1 734, c/2 952, c/3 1080, 0/1 44, 0/2 844, 0/3 1125, 1/2 844, 1/3 1125, 2/3 1035. The patient was currently in the hospital for bad gait and speech problems. The patient had been hospitalized for 10 weeks. Extensive reprogramming had been performed by the neurologist and only programming electrodes 0 and 1 seemed to help the patient. The patient was programmed on the shorted contact. It was stated that the patient¿s system was fine prior to hospitalization.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3830617
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« Reply #162 on: July 04, 2014, 09:12:05 PM »

Model Number 37612
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that there were problems recharging. It was noted that the patient had a hard time charging. It was noted that ever since implant the patient had problems charging. It was noted that the patient usually only got 4 bars and it took a lot of adjusting of her body and she had to ¿prop her boob up. ¿ patient had seen the manufacturing representative last in (b)(6) 2013. It was noted that after 1. 5 hours of charging the patient only got to 50% and the charge would only last about 6 hours. It was noted that the first time the implantable neurostimulator (ins) was too deep and they went back in and moved the ins and had to redo one of the leads in (b)(6) 2013. The recharger would not fully charge the implant. Anomaly appeared to have occurred through product use. There was no indication of patient harm. It was later reported coupling seemed to be the issue with the rechargeable device. It was noted that the patient would recharge for 45 minutes to an hour daily and get up to 50%. It was noted that the recharger seemed to deplete much quicker. Patient had a ¿faulty¿ electrode on the right side and had surgery to replace the lead in (b)(6) 2013. Additional information received reported the patient was still having concerns with their device or therapy but was working with their healthcare professional or manufacturing representative. It was noted that the patient had an appointment scheduled for (b)(6) 2014.

Manufacturer Narrative
Concomitant products: product id 3389s-40, lot# v944205, implanted: (b)(6) 2013, product type lead; product id 3389s-40, lot# v425792, implanted: (b)(6) 2010, product type lead; product id 3389s-40, lot# v425792, implanted: (b)(6) 2010, explanted: (b)(6) 2013, product type lead; product id 37751, serial# (b)(4), product type recharger. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3864325
« Last Edit: September 19, 2015, 12:49:38 AM by dennis100 » Logged
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« Reply #163 on: July 04, 2014, 11:53:26 PM »

Model Number 7426
Event Type Injury
Patient Outcome Required Intervention,Hospitalization
Manufacturer Narrative
Concomitant medical products: product id 3387-28, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2014, product type: lead. (b)(4).

Event Description
It was reported that 18 months prior to report, the impedance values of the patient¿s #0 and #2 electrodes suddenly decreased. It was further reported that this ¿resulted in high-power stimulation and the patient presented with symptoms of internal capsule stimulation. ¿ it was stated the patient¿s physician considered the ¿possibility of a lead problem¿ and it was decided to replace the patient¿s leads on (b)(6) 2014. It was reported that following the replacement of the lead, the patient¿s ¿impedance values had not changed at all. ¿ it was stated ¿the problem was not attributable to the lead¿ and ¿the physician did not know what might be a possible cause. ¿ additional information stated that when stimulation was performed on (b)(6) 2013 there ¿were fluctuations in the electric current value due to fluctuations in impedance. ¿ it was reported that when impedances were checked on (b)(6) 2013 ¿there were no problems with the left electrode¿ and that the right electrode¿s #0 and #2 had ¿low¿ impedances. Impedance records indicate the ¿low¿ values for contacts #0 and #2 were 346 ohms and 479 ohms respectively. It was stated the patient¿s ¿neck was still in pain¿ and that it was ¿difficult to face right. ¿ it was reported that ¿tension in the right dominant sternocleidomastoid (scm) was the most noticeable¿ and that it was also noticeable in the patient¿s right trapezius muscle. It was noted the patient had ¿botulinus administered on (b)(6) 2013 and that ¿it was difficult to control the patient¿s symptoms in their neck region, so botulinus was used concurrently. ¿ it was reported that ¿dystonia was not triggered through stimulation in the left finger like it was in the past. ¿ it was stated the patient had been previously hospitalized at a neurological hospital in (b)(6) 2012. It was further reported that impedance testing performed on (b)(6) 2014 found ¿low¿ impedances on electrodes #0 and #2 of 259 ohms and 356 ohms respectively ¿ both measured at 2. 5 volts. It was again noted these impedances were ¿too low. ¿ while performing stimulation testing it was reported the patient experienced their left hand being ¿heavy. ¿ it was stated the patient could not fully extend their fourth or fifth fingers at times during the test. Eventually it was noted the patient could extend their fourth finger ¿if done consciously. ¿ it was additionally reported that a surgery was performed on (b)(6) 2014 ¿to shift the dbs (deep brain stimulation) electrode on both sides. ¿ it was stated this was performed because ¿there was a problem with the electrode placement position itself¿ and ¿there was a concern about whether the impedance was low due to the dbs electrode. ¿ it was further stated there ¿seemed like there was a problem with the dbs electrode itself (disconnection?). ¿ it was reported that after the surgery to shift the electrodes, the impedances in the right electrodes #0 and #2 were ¿still low. ¿ the ¿low¿ therapeutic impedance values when measured at 3 volts were found to be 269 ohms and 374 ohms for electrodes #0 and #2 respectively. It was stated that ¿when the electric current was applied¿ the patient complained of ¿tingling sensations in the implantable neurostimulator (ins) region. ¿ it was further stated the patient reported the ¿ins was painful¿ and the ¿ins was tingling. ¿ it was reported it was ¿slightly difficult to extend [their] left fingers¿ and ¿slightly difficulty to bend [their] right fingers¿ during a stimulation test. It was additionally reported that during the stimulation test the patient¿s right upper limb and lower left limb were ¿slightly heavy¿ and the right bottom half of the patient¿s body ¿felt tingly and fuzzy. ¿ it was stated the patient¿s shoulder also felt ¿strained. ¿ impedance testing performed on (b)(6) 2014 indicated the right electrodes #0 and #2 had impedances of 294 ohms and 432 ohms respectively. Impedance testing also indicated the right bipolar electrode pair 1-3 had an impedance value ¿>2000¿ ohms. It was noted that electrodes #0 and #2 ¿were both five years old. ¿ additional information reported ¿electrode replacement surgery was performed, however, the resistance value was low and did not change. ¿ it was stated there was ¿possibly a problem with the electrode and there was a problem with the indwelling position of the lead as well. ¿ it was noted that on (b)(6) 2014 a lead was ¿extracted¿ and would be collected at a later date for analysis. It was additionally noted that ¿since the low resistance continues even after changing the ins and lead, the cause of the low resistance could be from the extension part. ¿ it was noted the patient was admitted to the hospital for ¿recovery¿ following their lead replacement procedure. Additional information stated ¿stinging sensations persisted¿ after the lead replacement was completed. Additional information stated the patient ¿had not had effective therapy¿ and the ¿cause was not determined¿ as of 17 days after initial report. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3855294
« Last Edit: September 19, 2015, 12:51:01 AM by dennis100 » Logged
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« Reply #164 on: August 11, 2014, 01:24:49 AM »

Model Number 37601
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that on (b)(4) 2014, the implantable neurostimulator (ins) reached elective replacement indicator (eri). The reporter stated that premature battery life was suspected. It was noted there was an eri notification for six days. It was further noted that impedance testing and reprogramming was done. The reporter stated the ins was replaced on (b)(6) 2014. It was noted the patient was programmed with the following settings ¿1-, 9-/ p 330 and r 150. ¿ it was noted that there were no patient symptoms or complications associated with this event. It was further noted the patient status at the time of this report was alive with no injury. Additional information received reported the ins was explanted on (b)(6) 2014. The reporter stated that no longevity calculation was done. It was further noted that some electrodes on the right hemisphere were out of range. It was noted that c and 11 had an impedance of 2456 ohms. Additional information was requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3960852
« Last Edit: September 19, 2015, 12:51:16 AM by dennis100 » Logged
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« Reply #165 on: November 08, 2014, 08:41:28 AM »

Model Number NEU_INS_STIMULATOR
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v497075, implanted: (b)(6) 2010, product type: lead; product id 37085-95, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 3389s-40, lot# v497075, implanted: (b)(6) 2010, product type: lead; product id 37085-95, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

Event Description
It was reported there was an impedance issue of unknown value on electrodes 9 and 11. It was noted the patient had their battery changed in (b)(6) and two electrodes shorted after the case. Since then the doctor couldn¿t program around the shorts and had turned the deep brain stimulator (dbs) off. The patient status at the time of report was alive with no injury and they had a less than 50% therapy relief. The dbs was off so the patient couldn¿t function. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4132520
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« Reply #166 on: January 10, 2015, 12:39:37 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va08mwk, implanted: (b)(6) 2014, product type: lead. Product id: 3387s-40, lot# va08mwk, implanted: (b)(6) 2014, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3387s-40, lot# va08mwk, implanted: (b)(6) 2014, product type: lead. (b)(4).

Event Description
It was reported there was a shocking or jolting sensation. They had shocking in the pocket and down the arm. It was unknown how long it had occurred and it was unknown if there were any falls or trauma associated with the change. There was high impedance >4,000 ohms on monopolar configuration. Both of the left and right monopolars were out of range but the right was much higher; the range was 16,000-20,000 ohms. The left side ranged from 3,300-5,600 ohms. The patient had already been referred to a neurosurgeon for possible revision. Additional information received reported they were going to do intraoperative troubleshooting because of a suspected issue with the electrodes. They would also check the extensions. The surgical procedure would happen on (b)(6) 2014. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4366231
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« Reply #167 on: January 10, 2015, 01:35:25 AM »

Model Number 7428
Event Date 11/01/2014
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that interrogation of the patient¿s implantable neurostimulator (ins) with a physician programmer ¿showed a charge density warning although the stimulation parameters were far beyond the warning limit. ¿ it was stated there were ¿stimulation/therapy issues¿ with ¿less than 50% therapy relief¿ at an unknown location. Ongoing troubleshooting was being performed due to the event at the time of initial report. The patient was alive with no injury at the time of report. It was noted the patient¿s right electrode was positioned in their subthalamic nucleus (stn). Impedance testing found that unipolar electrodes 6 and 7 (on the patient¿s left half) had impedances ¿>4000¿ ohms when tested at 3 volts. Interrogation records indicated the patient¿s right half therapeutic impedance was ¿>4000¿ ohms and the left half returned a ¿???¿ impedance value. It was noted the patient¿s left half was ¿not included in the therapy¿ and was ¿set to 0 volts¿ while the patient¿s right half was set to 1 volt. The patient was reportedly ¿ok¿ 18 days after initial report, but their ¿therapy was not 100% effective. ¿ the patient was noted to be scheduled to receive a ¿new ins¿ and undergo an additional impedance test and troubleshooting during an appointment scheduled for 2015-(b)(6). Additional information has been requested; a supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4362417
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« Reply #168 on: January 10, 2015, 11:25:26 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that high, but not out of range impedances were measured. The manufacturing representative was contacted on the day of this report by the patient¿s healthcare professional (hcp) because, the patient programmer was displaying end of service (eos). The battery depletion was considered premature. The manufacturing representative met with the patient on the day of this report and ran impedances. The only electrodes that seemed out of ordinary were zero and six. All pairs with electrode zero on the left lead were between 13,000-15,000 ohms and all pairs with electrode six on the right lead were between 6,000-7,000. The patient¿s left subthalamic nucleus was programmed to 0-, 3+ and the right subthalamic nucleus was programmed to 4-, 7+. The manufacturing representative did not change the programming since the patient did not have any tremors and they were receiving good therapy. The patient¿s implant incision was also infected due to the ruptured breast implant. The patient¿s hcp was treating and monitoring the infection. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Product id 3387s-40, lot# v650839, implanted: 2011 (b)(6); product type lead product id 3387s-40, lot# v650839, implanted: 2011 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4295123
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« Reply #169 on: February 07, 2015, 06:37:04 AM »

Model Number 37601
Event Date 01/09/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id neu_unknown_lead, lot# unknown, product type; lead. (b)(4).

Event Description
It was reported the lead was damaged during implant. Electrode three on the distal end of the lead was stretched, frayed, and cut off of the end during the procedure and would not insert into the extension properly. The lead was damaged when the healthcare professional (hcp) used forceps to pull the boot off. The lead was being revised because the hcp felt the lead was placed slightly lateral. The lead was implanted and impedances were measured. Impedances of electrodes one and two were measured to be normal. Electrodes one and two were the electrodes that showed the most efficacy during testing. On 2015-01-10, the impedances were checked again and they were normal. The patient was receiving effective therapy and tremor control.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4465068
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« Reply #170 on: March 07, 2015, 04:37:46 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Manufacturer Narrative
Age at time of event: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Concomitant medical products: product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id 3389s, lot# unknown, product type: lead; product id neu_unknown_ext, lot# unknown, product type: extension; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_ext, lot# unknown, product type: extension; product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id neu_unknown_ext, lot# unknown, product type: extension; product id 3389s, lot# unknown, product type: lead. (b)(4).

Event Description
Matzke, c. , hammer, n. , weise, d. , lindner, d. , fritzsch, d. , classen, j. , melxensberger, j. , winkler, d. Deep brain stimulation using simultaneous stereotactic electrode placement : an alternative to conventional functional stereotaxy? der nervenarzt. 2014. Doi: 10. 1007/s00115-014-4214-4. Summary: the subthalamic nucleus region (stn) is undoubtedly one of the most preferred target regions for the stimulative treatment of idiopathic parkinson¿s disease (ipd). In addition to pre-operative imaging and secondary image processing, actual electrode placement is the subject of present discussions. Here, the stereotactic principle is the key to success. An entirely new approach and, in its importance not previously appreciated one, is that of an individualized and semi-automated procedure for the stereotactic care of patients. The system presented in this study offers the opportunity for the first time to discuss an individualized procedure in the context of functional stereotaxy. The basis and at the same time limitation of the conventional stereotactic systems used hitherto is their rigid structure in terms of inflexible ring systems fixed to the patients¿ head. Reported events: 1. One patient with bilateral deep brain stimulation (dbs) for parkinson¿s disease had an infection in the generator pocket. It was noted that this complication was conservatively treated. 2. One patient with bilateral deep brain stimulation (dbs) for parkinson¿s disease had an infection in a bone anchor placed in the anterior area. It was noted that this complication was conservatively treated. 3. One patient with bilateral deep brain stimulation (dbs) for parkinson¿s disease experienced an electrode break. This defect reportedly led to electrifying sensations in the head region and a need for revision. 4. One patient with bilateral deep brain stimulation (dbs) for parkinson¿s disease experienced an infection in the temporarily externalized electrode cable during the test phase. 5. One patient with bilateral deep brain stimulation (dbs) for parkinson¿s disease experienced a ballooning of the generator pocket requiring revision as a result of a collection of cerebral spinal fluid (csf). The source literature included the following device specifics: quadripolar platinum/iridium electrode model 3398 and activa implantable neurostimulator unknown model number further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4551755
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« Reply #171 on: July 15, 2015, 11:21:27 PM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Product id 7426, serial# (b)(4), implanted: 2011 (b)(6); product type implantable neurostimulator product id 3389-40, lot# j0313908v, implanted: 2003 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2003 (b)(6); product type extension product id 3389-40, lot# j0313844v, implanted: 2003 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2003 (b)(6); product type extension. (b)(4).

Event Description
It was reported that during an implantable neurostimulator (ins) replacement surgery, the healthcare professional (hcp) noticed there was damage to the left extension. There was a severed connection in the area near the ins and the ins was twisted in the pocket. The right ins was replaced since the ins was at end of service (eos). The left ins was not replaced because, the patient was not consented for an extension replacement. The patient was not having any therapy issues related to the left ins. Prior to surgery, the manufacturing representative did not do telemetry with the ins. After they surgery, the left ins was interrogated and a short was noticed on electrodes 0 and 3. Impedances of less than 50 ohms were measured on 0-3. The cause of the event was not determined. The left ins was turned off until the revision and the patient was experiencing symptoms on their right side. Another revision was planned on the left side to replace the extension and ins.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4868358
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« Reply #172 on: July 15, 2015, 11:22:51 PM »

Model Number NEU_INS_STIMULATOR
Event Date 05/20/2015
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3387-40, lot # va0srqe, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead; product id 3387-40, lot # va0srqe, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead. (b)(4).

Event Description
It was reported the patient experienced ¿stimulation in the wrong location¿ and a ¿change in gait¿ involving their ¿left side implant. ¿ it was further reported the patient ¿had new-onset gait freezing with stimulation. ¿ a post-operative ct scan was performed and found the patient¿s ¿lead had deviated when it left the insertion cannula (20mm above the target)¿ and that ¿this resulted in the electrodes being positioned in the wrong brain structure (the posterior subthalamic area (psa), not the subthalamic nucleus (stn) as planned). ¿ it was noted the ¿left lead deviated¿ and that ¿both leads were revised as both ended up medial to the initial plan. ¿ it was additionally noted there was a ¿bent lead. ¿ the patient¿s leads were explanted and replaced as a result of the event. The patient was ¿receiving effective therapy with no gait freezing¿ following their bilateral lead revision. Additional information was requested; a supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4850234
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« Reply #173 on: September 07, 2015, 06:57:39 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/23/2015
Event Type Injury
Manufacturer Narrative
Concomitant product: product id: 977a290, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead. (b)(4).

Event Description
The health care provider (hcp) reported via the company representative (rep) that on (b)(6) 2015 the lead, implanted in the occipital right, was removed in emergency after "the externalization of the electrode under the skin. " in absence of the electrode, the pain felt by the patient was not correctly/properly relieved. The issue was resolved at the time of the report. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5021186
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« Reply #174 on: September 07, 2015, 06:58:28 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/12/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, explanted: (b)(6) 2015, product type: lead. Product id: 3389-40, lot# 0209659132, implanted: (b)(6) 2015, explanted: (b)(6)2015, product type: lead. (b)(4). (b)(6).

Event Description
It was reported the patient experienced a return of rigidity symptoms after falling down. Impedance testing was performed and found ¿high impedances on his right brain. ¿ the patient¿s physician decided to replace their lead as a result of the event. Upon connecting a replacement lead with the patient¿s original extension, the physician experienced a ¿problem when he tightened the screw; he found that two electrodes were broken. ¿ the physician then stopped and removed the replacement lead. The patient¿s physician ¿planned to revise the case again¿ the month after initial report. There was ¿no¿ patient injury or death from the event. The patient was being treated with medication at the time of report and was awaiting recovery to undergo an additional revision procedure. Additional information was requested; a supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4964692
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« Reply #175 on: September 07, 2015, 06:59:15 AM »

Model Number 37602
Event Date 07/17/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# v259066, implanted: (b)(6)2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6)2009, product type: extension. Product id: 37602, serial# (b)(4), implanted: (b)(6)2013, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 3389s-40, lot# v032588, implanted: (b)(6)2007, product type: lead. (b)(4).

Event Description
A consumer reported that when they were in recovery after the implantable neurostimulator (ins) was replaced, a health care provider (hcp) mentioned that only one electrode was working. Out of surgery, all electrodes were working and the leads were working when the patient left. Since the ins replacement, the patient had diplopia in their left eye. There were no falls or accidents and the patient had an appointment scheduled with an ophthalmologist. The patient's indication for use is parkinson's dual and movement disorders. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5003946
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« Reply #176 on: September 19, 2015, 02:55:43 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/29/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 3387-28, serial# (b)(4), implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. (b)(4). Device analysis for extension nkn101030v revealed the distal end conductor was broken up to transition point.

Event Description
The company representative (rep) reported that a malfunction occurred. During surgery all connections were made for the lead, adaptor, and stimulator. Then the impedances were checked prior to closing the incision, however, all measurements involving electrode 2 (c2, 12, 23) showed a value in excess of 40,000 ohms. The adaptor connection was disconnected and reconnected four times or so and wiping the connection, however, the situation of excess of 40,000 ohms did not change. Subsequently a twist-lock cable was used for checking the impedances of the lead alone; no abnormality was detected with the lead impedance. A new adaptor was unpacked, which recovered to normal impedance value. It was noted that considering the fact that all measurements related to electrode 2 were abnormal, there might be a fracture in electrode 2. It was also stated that electrode 2 was completely bad, so perhaps it was disconnected. An investigation was requested. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5024798
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