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Author Topic: Deep brain stimulator - Electrodes  (Read 73204 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


« Last Edit: February 03, 2014, 02:15:58 AM by dennis100 » Logged
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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

« Last Edit: February 03, 2014, 02:17:13 AM by dennis100 » Logged
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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

« Last Edit: February 03, 2014, 02:17:53 AM by dennis100 » Logged
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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
« Last Edit: February 03, 2014, 02:18:37 AM by dennis100 » Logged
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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

« Last Edit: February 03, 2014, 02:19:31 AM by dennis100 » Logged
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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
« Last Edit: February 03, 2014, 02:20:31 AM by dennis100 » Logged
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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

« Last Edit: February 03, 2014, 02:21:01 AM by dennis100 » Logged
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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

« Last Edit: February 03, 2014, 02:21:47 AM by dennis100 » Logged
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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
« Last Edit: February 03, 2014, 02:22:40 AM by dennis100 » Logged
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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


« Last Edit: February 03, 2014, 02:23:59 AM by dennis100 » Logged
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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

« Last Edit: February 03, 2014, 02:24:39 AM by dennis100 » Logged
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