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Author Topic: Deep brain stimulator - Misc. Adverse Events  (Read 101456 times)
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dennis100
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« on: November 05, 2013, 11:57:32 AM »

Model Number IPGNEURO
Device Problem Electro-magnetic interference (EMI)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that when the patient went into a (b)(6), he suddenly began to run around the store "banging into people and posts with the cart he was pushing". When his spouse got him outside the store, she turned the neurostimulator back on. At (b)(6) it was noted that he did not know "what a hamburger was or what to do with it". Since this time, the patient had been in and out of rehabilitation and was presently in a geriatric psychiatric unit. It was noted that the physician who implanted the device told the patient's family that the security system probably turned the stimulator on and off over a hundred times while he was in the store. Unable to follow up with the contact information provided hence no additional information was obtained.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2187848
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dennis100
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« Reply #1 on: November 05, 2013, 11:58:25 AM »

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

Literature: deogaonkar m, nazzaro jules m, machado a, rezai a. Transient, symptomatic, post-operative, non-infectious hypodensity around the deep brain stimulation (dbs) electrode. J clin neurosci. 2011; 18(7): 910-915. Doi: 10. 1016/j. Jocn. 2010. 11. 020. Summary: the authors discuss morphological characteristics of post-operative edema around a dbs lead in pts who presented between 2004 and 2009. Reportable event: one (b)(6) female presented to the emergency room with neurological deficits 7 days following stn dbs implantation. Edema was found subcortically. The pt was given steroids for 60 days for this to resolve. See literature article with mfr report# 3007566237-2011-07706.
 
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2250680

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dennis100
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« Reply #2 on: November 05, 2013, 11:59:04 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 #3 on: November 05, 2013, 11:59:42 AM »

Model Number IPGNEURO
Device Problem No Information
Event Date 01/01/2005
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported the patient was hospitalized three days after implant with "weakness, rigidity, and inability to ambulate. " it was noted the patient still had significant "off-on" symptoms despite the deep brain stimulation system. No other interventions were reported. No further follow up is possible.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2276333
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dennis100
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« Reply #4 on: November 05, 2013, 12:00:56 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 01/01/2004
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported a (b)(6) man was with chronic lymphatic leukemia was treated for parkinson's disease with deep brain stimulation (dbs). It was also stated, the pt had undergone a pallidotomy in 1996. On (b)(6) 2004, the pt had dbs electrodes placed. It was stated, the pt became drowsy and uncooperative during surgery, and showed evidence of hemiparesis. This was followed by a decreased level of consciousness. A ct scan showed evidence of intraventricular bleeding. It was stated the pt's post-operative course was complicated by aspiration pneumonia, atrial fibrillation, and tension pneumothorax. The pt subsequently developed sepsis, which was treated with antibiotics. There was worsening of pulmonary function requiring mechanical ventilation. The pt expired. It was not clear from the info provided how long after the attempted implant procedure the pt expired. No further follow up will be attempted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2288394

« Last Edit: February 04, 2014, 03:55:00 AM by dennis100 » Logged
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« Reply #5 on: November 05, 2013, 12:01:26 PM »

Model Number IPGNEURO
Device Problem Device displays error message
Event Date 01/01/2011
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that an out-of-regulation (oor) condition occurred and a "call your doctor" icon was shown. The pt could not adjust stimulation. Additionally the right stimulator could not be detected with the pt programmer. Refer to manufacturer report #3007566237201108826.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2322712

« Last Edit: December 04, 2013, 07:04:20 AM by dennis100 » Logged
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« Reply #6 on: November 05, 2013, 12:03:18 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 11/13/2009
Event Type  Injury   Patient Outcome  Other
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. Add'l info has been requested. A copy of this article can be accessed at http://thejns. Org/doi/abs/10. 3171/2009. 10. Jns09918.
 
Event Description

Literature: chang ch, chen sy, hsiao yl, tsai st, tsai hc. Hypomania with hypersexuality following bilateral anterior limb stimulation in obsessive-compulsive disorder. J neurosurg. Jun 2010;112(6):1299-1300. Summary: this article discusses a case of a (b)(6) male pt with an 8-year history of obsessive-compulsive disorder (ocd) who experienced hypomania and hypersexuality during bilateral deep brain stimulation (dbs). One-sided stimulation did not induce this effect. Event: the pt experienced mild euphoria and decreased obsessive thoughts while bilateral dbs was turned on at 8v, which dissipated when stimulation was turned off. Two weeks after this test, stimulation was set to 3v. After three weeks of stimulation, the pt had energy improvement, a decreased need for sleep, increased sexual desire and frequent sexual thoughts, although the ocd symptoms persisted. The pt was a christian and was uncomfortable with the increased sexual drive. Because of the persistent symptoms, stimulation was turned up to 4v and at a two week f/u, the pt had quick mood changes, an unstoppable sexual desire and was quicker to anger, but the ocd symptoms still persisted. Stimulation was increased to 4. 5v. A few days later, the pt experienced severe suicidal ideation due to the persistent symptoms and hypersexuality. The stimulation was decreased to 1v, and the hypersexuality had subsided by the time of the next two week f/u. The pt was depressed, however, because the ocd condition remained the same as before surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2149507
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dennis100
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« Reply #7 on: November 05, 2013, 12:04:10 PM »

Device Problem No Known Device Problem
Event Date 04/19/2011
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported the pt's obsessive compulsive disorder symptoms were deteriorating. The pt had anxiety increase, panic attacks, and withdrawal symptoms due to tapering and stopping serotonin-norepinephrine reuptake inhibitor (snri) treatment. The event resulted in in-patient hospitalization. The pt stopped taking venlafaxine and started taking lorazepam. The event was ongoing. About (b)(6) later the pt had obsessions, compulsions, and anxiety due to worsening or exacerbation of the pt's ocd. The event resulted in in-patient hospitalization. The device was reprogrammed, and the pt recovered without sequelae.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2155967

« Last Edit: December 04, 2013, 06:37:54 AM by dennis100 » Logged
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« Reply #8 on: November 05, 2013, 12:05:27 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 11/01/2010
Event Type  Injury   Patient Outcome  Other
Event Description

Literature: calado a, semedo c, dias m, et al. [subthalamic nucleus deep brain stimulation for parkinson disease: initial experience from centro hospitalar de lisboa central]. Sinapse. 2010;10(2):5-10. Summary: the authors report on 13 patients who received deep brain stimulation (dbs) from (b)(6) 2007 to (b)(6) 2009; 12 patients underwent bilateral stimulation of the subthalamic nucleus and 1 pt underwent unilateral stimulation. Mean age was 62 (48-68); there were 9 male patients and 4 female patients. Twelve of the 13 patients presented complications, with a total of 27 complications. A complication was defined as "any new symptom or escalation of a preexisting symptom". Complications were classified as severe if they were disabling, interfered with activities of daily living in a relevant manner, if urgent treatment was needed, if hospitalization or surgery was required,or if it was life threatening or led to death. A complication was classified as moderate if it interfered with activities of daily living or if any treatment was needed. A complication was classified as mild if it was tolerated, did not interfere, or only slightly interfered with activities of daily living or did not require treatment. Reportable event: one pt suffered intraoperative intracerebral hemorrhage, which was severe and symptomatic but evolved without secondary complications. This pt was reduced to unilateral stimulation, on the opposite side of the hematoma. At 6 months, this intracranial hemorrhaging had progressed without secondary motor complications.
 

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. The pt info provided in section a is the average for all the patients. At this time no add'l info was available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2159399
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« Reply #9 on: November 05, 2013, 12:05:51 PM »

Model Number IPGNEURO
Device Problem Device operates differently than expected
Event Date 06/10/2011
Event Type  Malfunction  
Event Description

The health care professional complained of multiple instances of the extension locking mechanism not locating positively and springing open. It was not clear if the mechanism had locked or not. The extension was able to be implanted. The patient was not injured and recovered without sequela. 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=2177108
« Last Edit: December 04, 2013, 06:38:28 AM by dennis100 » Logged
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« Reply #10 on: November 05, 2013, 12:06:34 PM »

Model Number IPGNEURO
Device Problem Low impedance
Event Date 07/20/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the patient felt stimulation in the neck and head beginning about (b)(6) prior to report. It was noted that the lead-extension connection site was along the patient's neck. Therapy impedance measured 491 ohms (46ua). Low impedances (50 ohms) were reported. Specific impedance measurements were as follows: o&c 569 ohms, 1&c 965 ohms, 2&c 950 ohms, 3&c ohms, 0&1 850 ohms, 0&2 817 ohms, 0&3 50 ohms with 234 ua, 1&2 1077 ohms, 1&3 861 ohms, 2&3 828 ohms. The lead was replaced. The patient incurred no injury and was well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2230450

« Last Edit: December 04, 2013, 06:39:17 AM by dennis100 » Logged
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« Reply #11 on: November 05, 2013, 12:07:11 PM »

Model Number IPGNEURO
Device Problem Device operates differently than expected
Event Type  Malfunction  
Event Description

It was reported that the patient was in a car accident and hit their head slightly. Since then their "thighs are constantly knotted into pain and their neck soft tissue was damaged and hurts all the time too. " it was reported that walking causes the patient severe pain. The patient visits their doctor "practically weekly" and she can get them moving, but the effect only lasts for about 4 hours. It was also reported that the patient's speech is slurred.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2256356

« Last Edit: December 04, 2013, 06:39:55 AM by dennis100 » Logged
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« Reply #12 on: November 05, 2013, 12:08:19 PM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 05/08/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: kluger bm, foote kd, jacobson ce, okun ms, lessons learned from a large single center cohort of patients referred for dbs management. Parkinsonism relat disord. 2011;17(4):236-239. Www. Elsevier. Com/locate/parkreldis. Doi:10. 1016/j. Parkreldis. 2010. 05. 003. Summary: the authors prospectively collected data on 108 patients who had received dbs surgery for the treatment of parkinson's disease, essential tremor, dystonia or other, at an outside institution and who were referred for further management in order to uncover potential lessons to optimize dbs. Reportable event: ninety percent of patients reported at least one area of symptomatic dissatisfaction with the results of their dbs. Common issues included pre-operative misdiagnosis ((b)(6)), presence or exacerbation of symptoms not addressable by current dbs technology ((b)(6)), lead misplacement ((b)(6)), and need for medication ((b)(6)) or dbs programming ((b)(6)) optimization. Overall, (b)(6) of subjects had no improvement, (b)(6) slight improvement and (b)(6) large improvement after medical and/or surgical management.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2245657
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« Reply #13 on: November 05, 2013, 12:09:22 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/22/2010
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative

(b)(4).
 
Event Description

Literature: foltynie 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 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 morbility. Reportable event: the authors report that in one pt, the procedure was abandoned because of prolonged superficial bleeding from a cortical vein and the consequent csf leakage from the dural opening resulted in a brain shift away from the skull. A decision was taken not to implant the permanent electrode after homeostasis was secured. Post-operative recovery was uneventful with no evidence of hemorrhage on postoperative imaging.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2246570
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« Reply #14 on: November 05, 2013, 12:11:13 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/22/2010
Event Type  Injury   Patient Outcome  Other,Required Intervention
Manufacturer Narrative

(b)(4): average for entire population used to complete this section.
 
Event Description

Literature: foltynie 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 hospital 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 parkinsons 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 authors report that following surgery, one pt did not have a follow-up assessment because of encephalopathy of unk original (presumed to be allergic) following electrode implantation which required removal of all dbs hardware a few days later (within the first 2 weeks). See literature article attached to mfr report # 3007566237201107448.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2246569
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« Reply #15 on: November 05, 2013, 12:12:30 PM »

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 05, 2013, 12:13:48 PM »

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 at. 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: two pts underwent further surgery for their parkinson's disease due to insufficient response from the first operation. An add'l bilateral globus pallidus internus (gpi) electrode was placed more than 1 yr after their stn dbs procedure because of persisting severe painful dyskinesias/dystonias. Neither of these pts has achieved good symptomatic control despite the add'l surgery. See literature article attached to mfr report # 3007566237201107448.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2246548

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« Reply #17 on: November 05, 2013, 12:15:09 PM »

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

(b)(4) - (pneumocephalus; hypodense area). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events.
 
Event Description

Literature: deogaonkar m, nazzaro jules m, machado a, rezai a. Transient symptomatic, post-operative, non-infectious hypodensity around the deep brain stimulation (dbs) electrode. J clin neurosci. 2011:18(7);910-915. Doi: 10. 1016/j. Jocn. 2010. 11. 020. Summary: the authors discuss morphological characteristics of post-operative edema around a dbs lead in pts who presented between 2004 and 2009. Event: one (b)(6) right-handed female with a history of idiopathic parkinson's disease (pd) was admitted for placement of bilateral stn electrodes. An immediate post-operative ct head scan revealed a small amount of pneumocephalus with no parenchymal hemorrhage. The pt was discharged on postoperative day 2 with a normal exam. Her second stage of surgery for ipg implantation was scheduled for a later date. Four days after her surgical procedure, the pt presented to a local emergency room (er) complaining of a new headache on the top of her head that would not go away with prescribed pain medications. Because the pt was confused, ct head scan was obtained which revealed a large hypodense area (4cmx4cmx6cm) centered around the left dbs electrode extending from the left basal ganglia to the subcortical region. Upon admission to the hosp, a small subgaleal fluid collection over the left burr hole was noticed. The pt's exam was otherwise normal. No local or systemic signs or symptoms of infection were present. The subgaleal fluid was aspirated and sent for gram stain, fungal stain and bacterial cultures, all of which were negative. The clinical symptoms improved to baseline over the next 4 days and the pt was discharged home on a short course of oral steroids. Antibiotics were not administered. A 1-week f/u.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2250724
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« Reply #18 on: November 05, 2013, 12:16:11 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/09/2011
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

(b)(4). Summary: the authors report on 7 pts (out of (b)(4)) with newly developed back pain after successful subthalamic nucleus deep brain stimulation (stn-dbs) and discuss the pathogenesis of newly developed back pain between (b)(6) 2003 and (b)(6) 2008 that developed 2 weeks to 5 months after surgery. Reportable event: diagnostic imaging of the spine, lumbar x-ray, ct or mri, revealed various lumbar spine pathologies such as lumbar disc herniation, lumbar spinal stenosis, scoliosis, spondylolisthesis, and old compression fracture. Two pts subsequently underwent lumbar surgery for their lumbar pathology, the authors performed lumbar laminectomy and discectomy for disc herniation, and laminectomy and pedicle screw-rod fixation for spondylolisthesis. One pt was treated with epidural injection, and the other four pts were treated conservatively with analgesic medication. The authors reported that the back pain was controlled well in all the pts.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2246715
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« Reply #19 on: November 05, 2013, 12:17:01 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 11/06/2010
Event Type  Injury   Patient Outcome  Other,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.
 
Event Description

Literature: deogaonkar m, nazzaro jules m, machado a, rezai a. Transient, symptomatic, post-operative, non-infectious hypo density around the deep brain stimulation (dbs) electrode. J clin neurosci. 2011; 18(7):910-915. Doi: 10. 1016/j. Jocn. 2010. 11. 020. Summary: the authors discuss morphological characteristics of post-operative edema around a dbs lead in pts who presented between 2004 and 2009. Reportable event: one (b)(6) male presented to the emergency room with worsening of symptoms (b)(6) following gpi dbs implantation. Edema was found at the tip of the lead. The pt had the fluid aspirated and was given steroids for (b)(6) for this to resolve. See literature article mfr report # 3007566237-2011-07706.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2250704
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« Reply #20 on: November 05, 2013, 12:17:40 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 11/06/2010
Event Type  Injury  
Event Description

Literature: deogaonkar m, nazzaro jules m, machado a, rezai a. Transient symptomatic, post-operative, non-infectious hypodensity around the deep brain stimulation (dbs) electrode. J clin neurosci. 2011:18(7);910-915. Doi: 10. 1016/j. Jocn. 2010. 11. 020. Summary: the authors discuss morphological characteristics of post-operative edema around a dbs lead in pts who presented between 2004 and 2009. Reportable event: one (b)(6) female presented to the emergency room complaining of worsening symptoms 9 days following gpi dbs implantation. Edema was found at the tip of the lead. No intervention was carried out and the edema resolved in 30 days.
 
Manufacturer Narrative

(b)(4): (pneumocephalus; hypodense area). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2250705


« Last Edit: December 04, 2013, 07:05:23 AM by dennis100 » Logged
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« Reply #21 on: November 05, 2013, 12:19:33 PM »

Device Problem No Known Device Problem
Event Date 07/15/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
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. A copy of this article can be obtained at www. Sobp. Org/journal.
 
Event Description

Literature: tsai hc, chen sy, tsai st, hung hy, chang ch. Hypomania following bilateral ventral capsule stimulation in a pt with refractory obsessive-compulsive disorder. Biol psychiatry. Jul 15 2010;68(2):e7-8. Summary: this article describes a case of hypomania following deep brain stimulation of the bilateral ventral capsule near the nucleus accumbens (nac) in a (b)(6) male pt with refractory obsessive-compulsive disorder (ocd). Prior to surgery, the pt's score on the yale-brown obsessive-compulsive disorder scale was 39 and the pt was taking sodium valproate, sertraline, clozapine, and lorazepine. The medications remained constant after surgery. Compulsive behavior included hand washing and spitting. Event: the pt became euphoric when stimulation was increased to 4 v to relieve the ocd symptoms which still persisted one month stimulation was started. The pt did not sleep the whole night and was hyperactive and restless. For two weeks these symptoms improved, but the pt became irritable. When told to stop hand washing, the pt became furious and broke a mirror with the right hand necessitating a trip to the er for a fractured wrist. Due to the rapid deterioration of mood and the aggressive behavior, the pt was admitted to the hospital for a suspected hypomaniac episode. The pt's medication was increased and stimulation was turned off. The hypomaniac symptoms decreased gradually within one week. Brief stimulation induced mild euphoria and decreased obsessive thoughts. A positron emission tomography showed significant activation of the nac ventral striatum during stimulation. The original stimulation settings were then maintained following the wishes of the pt's family. Two months later, symptoms still persisted. The pt then underwent revision surgery in which the stimulation sites were moved to more distal placements. The ocd symptoms persisted, but hypomaniac symptoms did not recur.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2139336
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« Reply #22 on: November 05, 2013, 12:21:10 PM »

Device Problem No Known Device Problem
Event Date 04/13/2010
Event Type  Injury   Patient Outcome  Other
Event Description

Literature: lai sc, jung sm, grattan-smith p, et al. Neuronal intranuclear inclusion disease: two cases of dopa-responsive juvenile parkinsonism with drug-induced dyskinesia. Mov disord. Jul 15 2010;25(9):1274-1279. Summary: this article described two children with neuronal intranuclear inclusion disease (niid) who presented with dopa-responsive juvenile parkinsonism, and who had initial good levodopa response that was complicated by disabling dopa-induced dyskinesia. Both patients died within 10 years of symptom onset. The article discussed differential diagnosis of clinical symptoms and neuropathological finds. Event: one female who underwent subthalamic nucleus deep brain stimulation (dbs) experienced a return of symptoms 6 months post surgery after initial improvement of tremor and bradykinesia, and depression and labile emotion one year after surgery. Subsequently, the patient experienced recurrent infections and died due to aspiration pneumonia approximately two years after surgery. The authors indicate that the patient's widespread pathology probably accounted for the lack of sustained response to dbs. The patient's motor symptoms prior to surgery had progressed rapidly and her cognitive function had declined. The patient had demonstrated severe gait ataxia, dysarthria, dysphagia, saccadic pursuit and nystagmus, blepharospasm and focal dystonia in distal limbs.
 
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. A copy of this article can be accessed at www. Interscience. Wiley. Com.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2143015
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« Reply #23 on: November 05, 2013, 12:23:23 PM »

Model Number UNKNOWN
Device Problem No Known Device Problem
Event Date 01/13/2010
Event Type  Injury   Patient Outcome  Other
Event Description

Literature: ince nf, gupte a, wichmann t, et al. Selection of optimal programming contacts based on local field potential recordings from subthalamic nucleus in patients with parkinson's disease. Neurosurgery. Aug 2010;67(2):390-397. Summary: this study investigated whether data regarding local field potentials (lfp) in the subthalamic nucleus (stn) could be used to identify in advance the optimal contacts for deep brain stimulation in patients with parkinson's disease (pd). Lfps are thought to represent aggregate activity from populations of neurons, synapses, axons and glia surrounding the electrode tip. Lfps with macroelectrodes placed unilaterally for deep brain stimulation (dbs) in 4 pd patients was recorded three weeks after electrode implantation before the start of long-term dbs. Subsequently, the patients underwent implantation of the pulse generator and post-operative dbs programming. The results were compared with the lfp data. Event: one patient's dbs device still had not been activated at the time of publication due to a persistent microlesion effect. The patient had undergone multiple microelectrode passes through the stn due to technical problems associated with the microelectrode recording, which never was successful.
 
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 regarding the patient, event, interventions and outcome has been requested. A copy of this article can be obtained at www. Neurosurgery-online. Com.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2141198

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« Reply #24 on: November 05, 2013, 10:41:53 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 11/04/2008
Event Type  Injury   Patient Outcome  Life Threatening
Event Description

Literature: ali z, prabhakar h, rath gp, dash hh. Enoxaparin induced intracerebral haemorrhage after deep brain stimulation surgery. Eur j anaesthesiol. Jul 2009:26(7):617-618. Summary: this article discussed a case of anticoagulant (enoxaparin) induced intracerebral hemorrhage in the post-operative period in a (b)(6) male parkinson's disease pt who underwent bilateral subthalamic nucleus deep brain stimulation (stn-dbs) surgery. The pt had a history of tremulousness of the right upper limb and both lower limbs associated with sluggishness of movements, decreased volume and slurring speech for three years, after which over a period of 6 months, the pt's symptoms progressed and examination revealed hypertonia, bradykinesia, rigidity, and postural instability. The pt also had a history of hypertension, coronary artery disease, and subdural hematoma. Event: following the second stage of the stn-dbs surgery during which the stimulator was implanted and during which the pt had mechanical ventilation, the pt's trachea was extubated and the pt was moved to the icu. On the fifth post-operative day, 40 mg of enoxaparin was administered to prevent deep vein thrombosis. The pt became unresponsive within a few hours of administration. The pt was reintubated and taken for a ct scan which revealed an intracerebral hematoma in the left basal ganglion and left fronto-parietal region with midline shift and perilesional edema. Prothrombin time and activated partial thromboplastin time were prolonged with a normal platelet count. Enoxaparin was discontinued and six units of fresh frozen plasma were transfused, while mechanical ventilation was continued. The pt's coagulation status returned to normal within the next four days, and there was an improvement in neurological status. The hematoma had resolved and was not expanding so no evacuation was performed. The pt then developed ventilator-associated pneumonia and sepsis due to methicillin-resistant staphylococcus aureus on post-operative day 25. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2120144

« Last Edit: December 04, 2013, 07:07:45 AM by dennis100 » Logged
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« Reply #25 on: November 05, 2013, 10:42:38 PM »

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, petersen 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 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 f/u after bilateral subthalamic dbs. Reportable event: one pt experienced a small delayed superficial cortical hemorrhage with mild postoperative dysarthria which resolved within 1 month of surgery and was thought to be unrelated to the bleed, and probably related to immediate postoperative edema around the electrode tip, given that this dysarthria could be reproduced by high-voltage stimulation on long-term f/u. There was no other hemorrhagic complication in this series of patients. See literature article with mfr report # 3007566237-2011-01161.
 
Manufacturer Narrative

(b)(4) (dysarthria). 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 patients. 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=2000231
« Last Edit: December 04, 2013, 07:09:11 AM by dennis100 » Logged
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« Reply #26 on: November 05, 2013, 10:43:01 PM »

Model Number IPGNEURO
Device Problems Coiled; Wire(s), breakage of
Event Date 09/22/2010
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 regarding the patient, event and outcome has been requested.
 
Event Description

Literature: burdick ap, okun ms, haq iu, et al. Prevalence of twiddler's syndrome as a cause of deep brain stimulation hardware failure. Stereotact funct neurosurg 2010;88(6):353-359. Summary: the authors reviewed their deep brain stimulation patient database to describe hardware complications which resulted from implantable pulse generator mobility, a phenomenon referred to as twiddler's syndrome. A prospectively collected database of adverse events for all center patients was queried searching for hardware malfunctions. Out of 362 total leads implanted in patients since 2002, 17 hardware malfunctions were identified. Among these 17 hardware malfunctions, 5 leads (in 3 patients) were identified after careful review to be twiddler's syndrome based on history, radiographic evidence and intraoperative findings during hardware revisions and are being reported in this article. Reportable event: a (b)(6) male had bilateral staged (3 months) ventralis intermedius nucleus dbs implantation. He weighed (b)(6) and was (b)(6) tall, giving him a body mass index of (b)(6). Within days of the placement of the second dbs system on his right side, he reported that he occasionally felt as though the ipg were standing perpendicularly within the pocket. He reported manipulating the ipg to relieve these sensations. One year after implantation of the first dbs system, he presented to the emergency room after awakening the night before with pain and swelling in his left posterior scalp. He reported that his scalp felt 'like a tube. ' it was presumed that the pain was due to pressure on the hardware during sleep, and he was prescribed anti-inflammatory medication and instructed to cushion the area at night. Five months later (17 months after implantation), his right-hand tremor recurred, and interrogation of the left ipg was unsuccessful (no contact could be established with the ipg for programming). Imaging was not obtained. He was diagnosed as having an ipg failure and taken to the operating room, and the left ipg was removed from the subcutaneous pocket and found to be very loose in the pocket. The extension cable was wound upon itself, fractured and completely severed 10 cm above the ipg. The ipg and extension cables were replaced. The pocket size was reduced by stitching the inferior and medial aspects and the ipg was anchored within the pocket. Three months following this revision, his left dbs system again failed. X-rays revealed kinking of the left intracranial lead 2 cm distal (superior) to the connection with the extension cable, and interrogation of the left ipg was not possible (again contact could not be made with the remote programmer). Interrogation of the right ipg showed normal impedances and current drain values for contacts 0 and 2 but high impedances and current drain contacts 1 and 3, suggesting a fracture within the lead. X-rays revealed the left extension cable had no evidence of twisting, but the right extension cable was moderately twisted. The patient felt that both ipgs were 'moving', especially when he lay supine, with the right ipg more problematic than his left. He was taken to the operating room and both ipg pockets were explored. The previously revised left ipg was immobile within the pocket and remained in the correct orientation. However, it still could not be remotely interrogated. The right ipg pocket was noted to be lax, and the ipg could be rotated within it. No tension was encountered in either extension cable. A new ipg was placed into the left chest pocket, and both ipgs were anchored securely. See literature article with mfr report# 3007566237-2011-02085.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2028319
« Last Edit: November 25, 2013, 08:27:40 AM by dennis100 » Logged
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« Reply #27 on: November 05, 2013, 10:43:32 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 12/16/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
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)). Between (b)(6) 2000 and (b)(6) 2008, the authors treated 132 patients, of these patients, 33 ((b)(6)) met disease onset criteria, and were included in the study sample: eighteen (ten men, eight women) yopd patients, and 15 (six men, nine women) rlopd. Preoperative 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 a proximal lead repositioning was required for one patient in the rlopd group which was performed during a battery change. This patient had their proximal lead revised due to on stimulation dyskinesia (at 1. 6v, 60 msec, 130 hz) (b)(6) after surgery. 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 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=2032518

*Dyskinesia
From Wikipedia, the free encyclopedia
 
Dyskinesia

Dyskinesia is a movement disorder which consists of adverse effects including diminished voluntary movements[1] and the presence of involuntary movements, similar to tics or chorea. Dyskinesia can be anything from a slight tremor of the hands to uncontrollable movement of, most commonly, the upper body but can also be seen in the lower extremities. Discoordination can also occur internally especially with the respiratory muscles and it often goes unrecognized.[2] Dyskinesia is a symptom of several medical disorders which are distinguished by their underlying cause.

http://en.wikipedia.org/wiki/Dyskinesia
« Last Edit: November 25, 2013, 08:38:36 AM by dennis100 » Logged
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« Reply #28 on: November 05, 2013, 10:44:04 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/14/2010
Event Type  Injury   Patient Outcome  Hospitalization
Event Description

Literature: boon p, dandachi-fitzgerald b, duits a, temel y, visser-vandewalle v, van den hout m. Modification of emotional states by bilateral stimulation of the subthalamic nucleus in a patient with parkinson's disease. J neurol neurosurg psychiatry. January 2011;82(1):117-118. Summary: the authors report on one parkinson disease patient who was successfully treated with bilateral subthalamic nucleus (stn) stimulation but showed postoperative gradual worsening of the psychological status. By using a single case experiment design (sced), the authors attempted to find out whether these problems were stimulation-related. Reportable event: the authors reported a (b)(6) woman with a 13-year-old history of pd with a slight depressive elevation. Psychiatric evaluation, however, revealed no psychopathology. The patient underwent a one-staged bilateral stereotactical implantation of electrodes and was discharged with stimulation at pole 1 monopolar, pulse width 90 ms, frequency 130 hz, 1. 5 v right and 1. 2 v left. In the 20 months following surgery, stimulation was adjusted up to 3. 0 v bilaterally to optimize motor function. During follow-up at 3, 6 and 12 months postoperatively, the patient increasingly complained of various psychological symptoms including depression, emotional instability and altered self perception. In addition, she reported a slow and unnatural speech. All these complaints interfered with her daily life, leading to social unease and marital problems. Depression scores increased after initial improvement to clear depression at the last follow-up. Neuropsychological assessment (with medication and stimulation on) showed no significant changes compared with preoperative assessment. Stimulation was never turned off for 12 h or more. After counseling in our institute, we referred the couple to marital therapy. Almost 2 years after surgery, she was admitted to our hospital, because her complaints had reached a crisis. After the neurostimulator was turned off for 12 h, she reported improvement in mood and speech however, severe motor symptoms recurred. Overall stimulation and medication adjustments were made and the patient reported that final adjustments to her regiment were most acceptable for her.
 
Manufacturer Narrative

(b)(4) altered self perception; slow and unnatural speech; social/marital unease. (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 regarding the patient and the event has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2028308

« Last Edit: November 25, 2013, 08:42:24 AM by dennis100 » Logged
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« Reply #29 on: November 05, 2013, 10:44:38 PM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 07/26/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4): (decrease in erectile and orgasmic function). 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: ackermans l, duits a, temel y, et al. Long-term outcome of thalamic deep brain stimulation in two patients with tourette syndrome. J neurol neurosurg psychiatry. Oct 2010;81(10):1068-1072. Summary: the authors conducted a follow-up study to report on the long-term (6 and 10 years) outcome in terms of tic reduction, cognition, mood and side effects of medial thalamic deep brain stimulation in two previously described tourette patients. Reportable event: in patient 1, ((b)(6) male), tic improvements were observed at 5 years and were maintained at 10 years; compulsions had disappeared. This patient revealed no changes in cognition during follow-up. This patient reported a reduction in energy when the current intensity reached the level necessary for an optimal effect on tics therefore, they turned down stimulation a few times during the day. This patient did experience a hardware-related complication consisting of traction of the lead in the neck. Multiple revisions of the wound and local injections were carried out with partial effect. This patient received two ipg replacements in 10 years. At long-term follow-up, there was a decrease in erectile and orgasmic function of this patient when compared with scores before and 5 years after surgery. This patient appeared to have difficulty driving his car with the stimulator on, because of a so-called blurred vision when looking ahead. Turning down the voltage by his patient programmer reduced these complaints. The adverse events experienced were not considered distressing at long-term follow-up.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943663
« Last Edit: November 25, 2013, 08:45:25 AM by dennis100 » Logged
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