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dennis100
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« on: November 06, 2013, 01:38:36 AM »

Model Number NEU_INS_STIMULATOR
Event Date 09/01/2012
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: mulroy, e. , quigley, g. , roberts, k. , cummins, g. , magennis, b. , fortune, g. , o'brien, d. , blunnie, w. P. , harrington, e. , gillivan-murphy, p. , kavanagh, e. , gilligan, p. , reilly r. , scola, p. , kelly, s. , murray, m. , lynch, t. Deep brain stimulation in ireland for parkinson's disease and essential tremor. The irish medical journal. 2012;105(8 ):11. Summary: deep brain stimulation (dbs) is highly effective neurosurgery for idiopathic parkinson's disease (ipd), essential tremor (et) and primary dystonia. Dbs involves stereotactic surgical implantation of a battery-operated stimulator into deep brain nuclei. (b)(6) patients are referred abroad for dbs and have to travel repeatedly for pre and post-operative care resulting in stress, anxiety and hardship. Safe pre and post-operative care of these complex, ageing patients is compromised by the absence of a dbs service in (b)(6). Moreover, both dbs surgery and the subsequent post-operative care abroad incurs substantial cost to the state. The (b)(6) institute at the (b)(6) university hospital ((b)(6)) is a non-profit institute for the care of patients with neurological diseases. The (b)(6) developed, in collaboration with the (b)(6) hospital and the (b)(6) centre, a dbs program in 2008/2009. We performed dbs at the (b)(6) campus on three carefully selected patients from a cohort of movement disorder patients attending the (b)(6) and continue to provide pre-operative assessment and post-operative care for patients following dbs in (b)(6) and abroad. Reported event: one year post dbs placement, the patient re-presented with recurrence of tremor and a feeling like "electric shocks" down his left arm due to dbs lead breakage. The shocks stopped once the dbs was switched off but his tremor reemerged. The patient was referred for repair, which was performed 9 months later. In the interim, he was again disabled by his severe essential tremor. He reports a significant improvement in his quality of life, activities of daily living and self-esteem post dbs. Further information has been requested; a supplemental report will be submitted if additional information is received.
 
Manufacturer Narrative

Product id neu_unknown_lead, serial# unknown, product type lead; product id neu_unknown_lead, serial# unknown, product type lead. (b)(4). The actual event dates were not provided. This date is based on the date of publication of the article.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2833108
« Last Edit: February 03, 2014, 01:29:11 AM by dennis100 » Logged
dennis100
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« Reply #1 on: November 06, 2013, 07:24:08 AM »

Model Number IPGNEURO
Device Problem No Information
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

The patient wished she never had the implant. She had an "air bubble" and "the skin separated from the bones". She had pain in the radial nerve of her left arm and the device made it, so her eyes could not open. The device has since been explanted. Further info is being requested from the hcp.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1590191

« Last Edit: February 03, 2014, 01:29:52 AM by dennis100 » Logged
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« Reply #2 on: December 06, 2013, 01:13:41 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that a week prior to the date of this report, the patient had a hard time moving his legs and arms. The patient was currently bedridden and unable to move. The patient would like to have the device reprogrammed. It was noted that the patient was currently hospitalized. It was later reported that the patient outcome was unknown. It was suggested that the patient to have programming done in the hospital but the result was unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3447058
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dennis100
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« Reply #3 on: December 07, 2013, 07:24:18 AM »

Model Number 37602
Event Date 11/23/2012
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead. (b)(4).

 
Event Description
It was reported that a healthcare professional (hcp) had noticed having high impedance issues with six patients over the past six months and hcp was "concerned about a potential product issue. " the issue described was patients that develop high, intermittent and weird impedance issues post-implant. In each case, the hcp had "gone back on these cases, wiped down contacts at the implantable neurostimulator (ins) site and reconnected and everything was fine. " components were not believed to be "changed out" due to this issue. It was reported on (b)(6) 2012 the patient had individual impedances >40 ,000 on her right side implantable neurostimulator (ins). Over the next few months, it was reported the impedances seemed to settle down except for the 0 contact which remained "very high". Thereafter, impedances began to rise on the right side; 0 and 1 contacts were >40,000. The patient experienced "shock-like" sensations in the left arm when laying down on her right side. The shock-like sensations went away when the ins was turned off. On (b)(6) 2013 patient had a revision of her right-side ins. The ins was disconnected, the prongs were wiped off with dry gauze, and the ins was reconnected. All impedances were found within normal limits. See mfr. Reports #3007566237-2013-03704, #3004209178-2013-20287, #3007566237-2013-03698, #3004209178-2013-17367, and #3007566237-201 3-03214 regarding the same hcp noticing similar issues with different patients.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3470536
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dennis100
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« Reply #4 on: December 07, 2013, 07:25:36 AM »

Model Number 37612
Event Date 10/13/2013
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
Concomitant products: product id 37612, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 3389s-40, lot # v006360, implanted: (b)(6) 2006, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 3389s-40, lot # v006360, implanted: (b)(6) 2006, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 37651, serial # (b)(4), product type recharger. (b)(4).

 
Event Description
It was reported that an emergency room physician contacted the manufacturer representative on sunday indicating the patient had shaking in his left arm. The patient was going to follow up with his physician on monday. The implantable neurostimulator (ins) was 100% charged, but the patient did not have his programmer on him to check. The patient did not want the device turned off. The er physician gave the patient medication. It was noted that impedance values in the operating room were all within normal range at 1. 5 volts. The physician was going to try to see the patient this week. It was reported that a loss of therapeutic effect occurred which was not related to stimulation therapy. The patient was in the er on (b)(6) 2013 for return of symptoms and dystonia on the left side of the body. It was suspected the right side ins was turned off, however the patient did not have his programmer to check. The patient had attempted to recharge the ins. The patient was transported from the emergency room to a different facility. The patient was admitted to the hospital due to worsening of dystonia. The physician¿s assistant was going to meet with the patient on (b)(6) 2013 to make sure the device was working and that the patient was recharging correctly, and to do some programming. It was noted the patient¿s left arm had been contracting. The physician¿s assistant turned stimulation on the right side up to 5. 3 volts and the patient was ¿doing fine. ¿ impedance measurements were ¿fine¿ as well. The patient was discharged from the hospital on (b)(6) 2013.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3450257
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dennis100
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« Reply #5 on: December 07, 2013, 07:27:03 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3447275
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« Reply #6 on: December 09, 2013, 05:53:57 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3233746
« Last Edit: February 03, 2014, 01:30:09 AM by dennis100 » Logged
dennis100
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« Reply #7 on: December 30, 2013, 06:59:26 AM »

Model Number 7426
Device Problem Explanted
Event Date 02/23/2004
Event Type  Other   Patient Outcome  Other
Event Description
Hcp reported pt presented in 2004 with signs of infection by generator pocket spreading into forearm. These include erythema and swelling. The pt was treated with device explantation and antibiotic therapy. Hcp reported pt was implanted with new device 4 months later. The device was not returned to the mfr for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=565936
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« Reply #8 on: December 30, 2013, 07:00:22 AM »

Model Number 7426
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Other
Event Description
Hcp reported patient had a right pallidotomy done previous to dbs implant in 2004. Device was turned on a adjusted in 02/2004. Pt developed left upper extermity dystonia. After multiple adjustments in ipg parameters and medication doses pt continues to have dystonia. The right ipg was turned off for a week with no change in the dystonia. Mri of the brain for lcoalization of dbs was one-- neurosurgeon decided no changes were necessary. Pt continues to have left upper extremity dystonia (mostly in the hand). No report of device explantation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=527430
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dennis100
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« Reply #9 on: December 30, 2013, 07:01:13 AM »

Model Number 7426
Event Date 08/05/2004
Event Type  Injury   Patient Outcome  Other,Hospitalization,Life Threatening,Required Intervention,Disability
Event Description
"cramps in left toes brought on violent convulsive bilateral synchronous agonizing motions legs, arms, ~6/sec, shocks felt like 208 volt shocks in past career as e. E. Radiated over 20 volts/per meter, stopping electric wheelchair, took over ambulance's pt monitor till shut off. Would restart spontaneously 612,000 over-voltage pulses/hour caused cramps, strong tremors, difficulty breathing suspect damage to left motor nerves for without neurostimulator left hand now steady, suspect very large electric pulses performed thalotomy. Also seem to have undergone form of operant conditioning, xxw/o neurostimulaton get all symptoms except for less violent trembling (strong tremors no sensation of electrocution). ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=550185
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« Reply #10 on: January 02, 2014, 02:10:33 AM »

Model Number 7428
Device Problems Explanted; Device stops intermittently
Event Type  Other   Patient Outcome  Other
Event Description
Hcp reports removal of dbs system due to aseptic inflammation secondary to excessive activity of the right arm. The patient was implanted with a dbs system in 2005. In 2006 the device was removed due to aseptic inflammation caused by excessive activity of the right arm. The device reportedly was turning off frequently. The device was explanted but not returned to the manufacturer for analysis. No further information on patient symptoms or outcome were reported. No additional information on patient symptoms or outcome.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=742356
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« Reply #11 on: January 03, 2014, 07:33:20 PM »

Model Number 3387
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Other
Event Description
The patient's husband reported, the patient is having difficulty in the right arm, she has experienced a difference in temperature; her right hand feels colder than the other hand. The patient also experienced tingling symptoms, located on the outside of the arm and extending to the thumb. The spouse reports the patient is having a very difficult time speaking. Additional information has been requested from the physician. 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=831179
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« Reply #12 on: January 05, 2014, 01:38:09 PM »

Model Number 7426
Device Problem Replace
Event Date 04/06/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
Final device analysis revealed broken welds at the bond wire pads.

 
Event Description
The hcp reported that, the pt experienced a sudden return of tremor with intention in his left arm and hand. The pt was unable to turn the stimulator on with the pt therapy manager; the pt usually turns the generator off nightly. The hcp was unable to interrogate the ins, and the other battery was reading low, the left-lead impedances were all within normal limits, so the pt was scheduled for bilateral ins replacement. The pt's ins was explanted and replaced. The pt recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=903173
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« Reply #13 on: January 05, 2014, 01:47:02 PM »

Model Number 7426
Device Problems Explanted; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 01/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The pt reported received a shocking or jolting sensation after exposure to a security gate at the public library. The device was turned on when the pt walked through the gate. The security gate turned the pt's device off. After leaving the library, the pt turned the device on and rec'd a shock in the left part of her face, neck and arm which lasted for three days. The pt has rec'd shocks previously when turning her device off but they did not last as long. Since the event, the pt has tried turning on her device numerous times with the same result. The pt is experiencing shaking in her left arm due to the device being kept off. Add'l info has been requested from the hcp but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=971941
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« Reply #14 on: January 05, 2014, 01:48:27 PM »

Model Number 7426
Device Problem Replace
Event Date 11/02/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient reported that he experienced an abrupt failure of his neurostimulator that resulted in violent dyskinesia of his left arm. The patient reported that the dyskinesia was uncomfortable and physically exhausting. The stimulator was replaced emergently 18 hours after it failed. No patient outcome was reported. The patient reported that the explanted device was to be returned to the manufacturer for analysis, but as of the date of this report, the device had not been received. Additional information has been requested from the hcp, but was not available as of the date of this report. A follow-up report will be sent if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=968721
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« Reply #15 on: January 08, 2014, 05:10:52 PM »

Model Number 3387
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient's husband reported the neurostimulator suddenly turned on, causing a tingling down the arm. The caller stated, the device had been off for quite some time due to a lack of efficacy. The patient's programmer confirmed the neurostimulator had turned on. Additional information has been requested by medtronic from the health care professional regarding the reported event. A supplemental mdr follow-up report will be sent to fda if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=877087
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« Reply #16 on: January 08, 2014, 05:12:34 PM »

Model Number 3389
Device Problems Device remains implanted; Implant, reprogramming of; Suspect EMI
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient reported following system reprogramming in 2005, his left foot would turn in, which made his knee hurt and he turned the right-side stimulator off. In 2006, the right-side stimulator was reprogrammed and turned on. One week later, his left arm and shoulder were stiff, his balance was poor and it was difficult to walk; the toes on his left foot curled. He reported his left shoulder and arm were worse with the stimulator off; he couldn't extend the arm over his head, it pulled up his side. The pt indicated he worked near high voltage and installed dc motors and rfid equipment readers, which may have damaged the dbs device and caused false readings. The following month, he was reprogrammed because problems with his left arm/shoulder and balance made work difficult. After reprogramming one month later, the pt reported no improvement in his symptoms. Approx four months later, the company representative suspected electrode migration at follow-up. His physician said the symptoms were due to disease progression; an implanting surgeon indicated the pt would not benefit from lead repositioning. The pt indicated after re-programming in 2007, the toes on his left foot curled up, he had slurred speech and poor balance. The company representative directed the pt to continue to report symptoms to his hcp. Additional info has been requested from the physician.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=884743
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« Reply #17 on: January 08, 2014, 05:13:21 PM »

Model Number 7426
Device Problems Performance; Loss of power; Device remains implanted; Unit inactivated; Implant, reprogramming of; Suspect EMI; Unable to interrogate
Event Date 08/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient reported, that he recently noticed the ins did not seem to be working. He checked with the patient programmer and the device was off; there was no output and he couldn't communicate with the ins. He may have been near a magnet, causing it to turn off. When he turned the ins back on, he felt a strong painful stimulus in his leg, arm and face on the right side, prior to output failure. A follow-up, the physician was unable to "get any real contact" with the device to reprogram it and the device was turned off. Additional information has been requested from the physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=915169
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« Reply #18 on: January 08, 2014, 05:13:58 PM »

Model Number 3387
Device Problems Performance; Device remains implanted; Implant, repositioning of
Event Date 04/01/1999
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt reported that subsequent to dbs system revision (lead and bilateral ipg replacement) in 1999, he experienced some tingling in his right leg, arm and on the right side of his face. Two months later, the lead was "adjusted slightly" and the situation was improved, but they were never able to get complete control of the right-sided tremor without inducing uncomfortable tingling on that side. The pt is left-handed, so right-sided symptom control was less important to him. He also would not inactivate right-sided therapy due to feeling uncomfortable stimulus any time that side was turned on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=915030
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« Reply #19 on: January 08, 2014, 05:14:43 PM »

Model Number 3387
Device Problem Device remains implanted
Event Date 06/10/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient reports, she felt a "clicking in her shoulder" and thought it was pinched nerve which she had experienced previously. The pain progressed to sharp shooting pain down the neck, shoulder, and into the arm affecting her hands. The patient is now experiencing numbness in her arm. The area impacted is the same area being treated by the implanted device. The patient reports x-rays show "things appear to be in place. " the patient has had two epidural blocks along with medication which have not helped. The patient turned off the dbs system to see if the symptoms would go away. The symptoms have not changed even with the device off. Additional information has been requested form the hcp, but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=916737
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« Reply #20 on: January 09, 2014, 10:47:33 AM »

Model Number 3387
Device Problems Device remains implanted; Unit inactivated; Implant, reprogramming of
Event Date 01/01/2005
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt reported, since implant in 2004, they have not had good therapeutic effect. The pt was implanted with a dbs system to treat essential tremor in their right hand. In 2005, the pt reported tingling in the tongue and arm. Reprogramming occurred once or twice but it was unclear if there was any effect. In eleven months later, the pt was feeling tingling in the hands and toes and then in 2006, the pt reported they became unable to walk. The pt indicated she was taking medications but did not provide any further info. The pt reported following several programming sessions in 2006, she turned the stimulator off. With the stimulator off, the pt reported the tingling is "very bad" and "very painful" and that she is using a wheelchair and can't walk. The pt reported mri scans had been performed but nothing was found to be the cause of her symptoms. Additional info has been requested from the pt's hcp but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=996516
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« Reply #21 on: January 09, 2014, 10:48:10 AM »

Model Number 3387S
Device Problem Device remains implanted
Event Date 01/03/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt reported that she felt buzzing in her brain and a mild electrical charge on the left side of her brain extending down to her left arm and side; her left arm was frozen. The symptoms started at 4:00 that morning and occurred when the stimulation was on. She reported that the symptoms are at the lead-extension connection and her paresthesia area; changes in her neck produced the sensations intermittently. The pt had no trauma. The pt reported her status as good and that she was at home. She reported that her therapy 'has been and still is excellent'. She planned on seeing her hcp in 2008.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=998306
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« Reply #22 on: January 09, 2014, 10:49:01 AM »

Model Number 3387
Device Problems Device remains implanted; Implant, reprogramming of
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient reported intermittent tingling from their left hand to left shoulder for the last week. The patient also reported a loss of efficacy occurs. The patient noted a blinking light on their programmer. Follow up with the hcp indicated the tingling was most noted in the evening. The hcp felt it may be related to increased baseline parkinson's symptoms and the blinking light was indicating the batteries in the programmer need replacement. The patient was seen about three weeks later for reprogramming of the dbs device. The amplitude was increased which resulted in improved tremor control to the right hand. The impedances were checked and were normal. The patient's parkinson's medications were also adjusted by the neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1000064
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« Reply #23 on: January 09, 2014, 10:49:42 AM »

Model Number 3387
Device Problems Implant, repositioning of; Implant, reprogramming of
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Journal ref: handforth et al. "deep brain stimulation of the subthalamic nucleus as adjunct treatment for refractory epilepsy. "epilepsia 2006; 47(7): 1239-41. This article describes two case reports of bilateral subthalamic deep brain stimulation (dbs) for refractory partial-onset epilepsy. Reportable event: a female with seizures since encephalitis at age six months was treated with bilateral subthalamic deep brain stimulation. At surgery, distortion by atrophy and prior craniotomy led to a left-lead assignment more dorsal than that of the right. After a second surgery, an mri indicated the left lead was now intra-stn. Adverse events of left arm and leg dyskinesia, diplopia, and disequilibrium resolved with reprogramming.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1000104
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« Reply #24 on: January 09, 2014, 10:50:48 AM »

Model Number 3387S
Device Problem Device remains implanted
Event Date 01/03/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient reported that she felt buzzing in her brain and a mild electrical charge on the left side of her brain extending down to her left arm and side; her left arm was frozen. The symptoms started at 04:00 that morning and occurred when the stimulation was on. She reported that the symptoms are at the lead-extension connection and her paresthesia area; changes in her neck produced the sensations intermittently. The patient had no trauma. The patient reported her status as good and that she was at home. She reported that her therapy 'has been and still is excellent'. She planned on seeing her hcp in 2008. A follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=990536
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« Reply #25 on: January 09, 2014, 10:52:48 AM »

Model Number 7426
Device Problems Electro-magnetic interference (EMI); Explanted; High impedance; Loss of power; Implant, reprogramming of
Event Date 11/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient had reported a loss of therapeutic effect; her symptoms began in 2007, around the thanksgiving timeframe. She had not gone "through any theft or security gates that were different than normal. " when the patient walks through security gates, "she walks quickly through the center of the doorway. " the patient had experienced symptoms of dyskinesia and had felt tingling in her left ear, left hand and left foot. The hcp had checked the device and no problem was detected, the patient was told the device was acceptable. Impedance values were given to the patient who subsequently contacted the implanting surgeon to review impedances (not provided to the company); the product had "defaulted to factory settings," only one ipg had reset to por. At follow-up (date unknown), the device had been reprogrammed; the patient returned "to the clinic where she was implanted and they reset her device. " the patient's status was good; the patient was redirected to report symptoms to the hcp. Information provided by the representative with returned product shows the patient had experienced tingling in her arm adn face. Telemetry results indicated the battery status as 'okay' (voltage 3. 74 v); electrode impedances were elevated on all electrode pairs except electrodes 0, 1 and 2. The event had been device related; the left-sided ipg and left-sided extension product was explanted and were returned for analysis. The patient has recovered without sequela. Additional information has been requested from the physician. Refer to mfr report #6000153200800269.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=980786
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« Reply #26 on: January 09, 2014, 02:23:20 PM »

Model Number 3387
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
Event Description
Journal reference: zesiewicz ta, sullivan kl, hoffman m, et al. Delayed thalamic intracranial hemorrhage in essential tremor pt following deep brain stimulation. Eur neurol 2008;59(3-4):187-189. We report the case of a man with et and a history of controlled hypertension who developed a delayed thalamic intracerebral hemorrhage (ich) almost 9 weeks following dbs surgery. Reportable event: the day after his nine week eval, which was normal, the pt woke up from an afternoon nap with right-sided arm and leg weakness, slurred speech, and a right facial droop. Neurologically, the pt was lethargic, oriented to his name and disoriented to place and time. Cranial nerve examination was significant for a right facial paresis. Motor examination demonstrated right upper and lower extremity weakness. Sensory examination demonstrated right hemi-hypoesthesia, and the pt had an extensor plantar reflex on the right. Ct and mri of the brain without contrast showed a left-sided thalamic ich adjoining the distal portion of the deep brain stimulator electrode. His dsb unit was turned off. His blood pressures remained stable, and he improved clinically having normal mmse, mild dysarthria, mild right facial weakness, and right upper and lower extremity weakness in the ensuing 6 weeks. He was able to ambulate with the use of a walker.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053631
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« Reply #27 on: January 09, 2014, 04:32:54 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 05/15/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported, the pt experienced a loss of therapeutic effect. The pt's tremor returned in the pt's left arm. The pt was admitted to the emergency room. The pt's status was undetermined at the time of the report. The batteries were changed in the pt programmer. There was no change in the pt's symptoms. Add'l info has been requested from the hcp, but was not available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1061693
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« Reply #28 on: January 09, 2014, 04:33:36 PM »

Model Number 7428
Device Problems Shock, electrical; Inappropriate shock
Event Date 01/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the pt experienced a shocking or jolting sensation in the fall of 2007. Recently, the shocking sensation has gotten worse. The pt feels the shocking sensation as the amplitude is increased to control his tremors. The shocking sensation affects the right arm and face. Add'l info has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1062273
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« Reply #29 on: January 09, 2014, 04:34:06 PM »

Model Number 7428
Device Problems Replace; Inappropriate shock
Event Date 12/17/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Final device analysis revealed no anomaly found; the implantable neurostimulator is functionally okay.

 
Event Description
Following implant, the pt reported a decrease in tremor control and some jolts in his right upper extremity and chest. No irregular impedance values were detected. In 2008, the right extension was replaced; the extension was not returned for analysis. The following month, he had his neurostimulator replaced; the device analysis determined the neurostimulator was functioning normally. There was no pt injury. The pt recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1064334
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« Reply #30 on: January 09, 2014, 04:35:52 PM »

Model Number 7428
Device Problems Device remains implanted; Inappropriate shock
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt experienced a fall or some other form of trauma. Since that time, he had a loss of therapeutic effect; the tremor in his left arm was returning and his speech was getting worse. The pt also experienced shocking/jolting sensation. Additional info has been requested from the hcp, a follow-up report will be sent if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1064799
« Last Edit: January 17, 2014, 10:24:28 PM by dennis100 » Logged
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« Reply #31 on: January 09, 2014, 04:36:21 PM »

Model Number 7428
Device Problems Device remains implanted; Inappropriate shock
Event Date 03/27/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Following battery replacement, the pt experienced a shocking/jolting sensation in his left arm. Following battery replacement and a fall or some other form of trauma ( date not reported), the pt experienced a loss of therapeutic effect, loss of balance, and dyskinesia. The pt was at home and was encouraged to contact his hcp. Additional info has been requested from the hcp, a follow-up report will be sent if additional info becomes available.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1064784
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« Reply #32 on: January 09, 2014, 04:37:41 PM »

Model Number 7428
Device Problem Replace
Event Date 10/31/2006
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
It was reported the pt underwent removal of the bilateral gpi dbs leads and implantation of stn placed leads. The pt had the dbs sys placed in 2005. The pt did not receive benefit. The pt became progressively more disabled despite implantation of dbs. The pt was evaluated prior to the revision. The pt's only new complaint was that he noted some difficulty urinating while standing although he felt he was able to fully empty his bladder while in a sitting position. He had no dysuria or other urinary tract complaints. The pt had been started on lasix 20 mg/day for peripheral edema in 2008. It had been somewhat effective in improving the edema in his hands and ankles. The pt had no shortness of breath, chest pain, or other cardiopulmonary complaints. The pt was admitted to the hosp in 2006. The pt's physical exam revealed blood pressure 112/64, heart rate 76, respirations 16, pt's weight which was decreased by two pounds since the month before. Exam was otherwise unchanged from previous exams. It was notable for an irregular cardiac rhythm, dyskinesias of the arms and legs, slow shuffling gait, and abnormal posture with the upper body held in a forward, flexed, position. There was trace to 1+ pedal edema noted. The leads were replaced. The new leads were connected to the previously implanted extensions and the generators were tested. The impedances were found to be normal. The procedure was well tolerated. The pt was discharged on two days later. Prognosis for improvement of pd motor symptoms was good.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1066633
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« Reply #33 on: January 09, 2014, 04:39:24 PM »

Model Number 7426
Device Problems Loss of power; Program, failure to
Event Date 04/02/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt woke up feeling fine. Forty five minutes later, the pt knew something was 'not quite right'. He started having more left-sided tremor and fell backwards, but was caught by a family member before he fell. It was also reported that the pt was unable to feel stimulation after a fall down the steps or some other trauma. The pt was unable to adjust stimulation. The pt was seen by his primary hcp the day of the incident. He had a neurology consultation approx 7 days after the original incident. There he had a pronounced increase in left arm tremor. It was harder for him to walk and he had been dragging his left leg more. Voice quality was originally alright, but later the pt noticed that he was stuttering more. He was having some drooling, greater on the right side. Facies were somewhat flat, although he could smile and laugh during the exam. He had micrographia. His last deep brain stimulator programming was four months prior to the exam. Physical exam also revealed left arm rigidity. He had +3 left arm rigidity and a 2-3 tremor, although at times it did quiet down. He had +1 increased tone and rigidity of his right hand. He was unable to do finger taps at all with his left hand and was able to do taps with his right, although he did demonstrate some bradykinesia. Hand pronation and supination again demonstrated bradykinesia bilaterally, left greater than right. He had strong hand grasp bilaterally. He did not drift with eyes closed and arms extended. He had a fine tremor, left greater than right when his arms were extended at rest. He had bilaterally increased tone and rigidity of the lower extremities. He was +2 on his right leg and +4 on his left. There was no tremor of his lower extremities at exam. Foot taps demonstrated decreased amplitude in his right more than left; both demonstrated bradykinesia. He arose independently from a chair using both arms to push up with multiple attempts. While up walking with his walker, he had some bradykinesia, but was able to pick up both of his feet and did not demonstrate any real shuffling at exam. He took a slow turn. No interrogation was possible with the device stimulating his right brain/left side of his body. Left brain neurostimulator settings and impedances were within normal limits. The hcp increased the stalevo 50 mg from 4 to 5 times a day. The pt and his wife were instructed how to increase his medications if needed to control his oral symptoms. The device had been or will be replaced.

 
Manufacturer Narrative
The report was submitted late by the mfr's rep, retraining has been conducted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1068140
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« Reply #34 on: January 13, 2014, 01:28:18 AM »

Model Number 3387
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 06/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that in 2007 while the stimulation was on, the patient experienced a headache and numbness in her legs and arms. There was no known accident or incident related to the symptoms. The patient was currently at home and had an appointment with her hcp. Additional information has been requested from the hcp, 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=1045939
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« Reply #35 on: January 13, 2014, 01:32:15 AM »

Model Number 7495-66
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 03/19/2008
Event Type  Malfunction   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
It was reported the pt began experiencing a loss of therapeutic tremor control on one side. The symptoms began shortly after the pt's left ipg was replaced. The pt reported receiving a shock down his arm and into his hand while taking a picture. Attempts to interrogate the pt's ipg were unsuccessful with the clinic programmer. The pt's programmer was tried and also resulted in a telemetry error. An attempt to interrogate the pt's other ipg (right side) was successful; however, ruling out a programmer error. The pt has very mild tremor on the right side, so it can be hard to tell if the pt is getting therapy from the left device, but it appeared the pt had more pronounced tremor. An x-ray was taken, but no results were reported. Based on the x-ray, the hcp scheduled the pt for surgery. The plan was to disconnect the extension, clean the area and reconnect the wire as well as open the ipg pocket and check the device for orientation. Follow up info indicated the left ipg pocket was opened and the battery checked. The device was not inverted, but was implanted deeper than the typical 1/2 inch (1-1. 5 inches). The ipg was interrogated and the battery was found to be fully charged; therefore, ruling out a depleted battery or short circuit. The same battery was placed superficial to the original pocket. Interrogation revealed normal impedance values and device settings. The extension pocket was then opened at the lead extension junction. The boot was removed form the extension, the contacts cleaned, extension head suctioned, and re-assembled with a new boot. The right ipg was changed out at this time as well and programmed to the last known settings. In recovery the devices were interrogated, found to be normal, and were programmed. The pt remained groppy and did not have his programmer, so the devices were left off until later time. The right battery was programmed for a slightly lower voltage to compensate for a fresh battery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1025678
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« Reply #36 on: January 13, 2014, 03:16:44 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: hyam; post-deep brain stimulation - gradual non-stimulation dependent decrease in strength with attenuation of multiple sclerosis tremor 2007/254/7/854-60. We describe five patients with multiple sclerosis in whom upper limb tremor severity gradually decreased over a period of several years after deep brain stimulation. In every case this attenuation of tremor was accompanied by increasing pyramidal weakness in the relevant upper limb. In two patients this attenuation of tremor remained after stimulation was permanently switched off. In one other patient, where upper limb strength remained normal, tremor severity gradually worsened in spite of continuing stimulation. The manufacturer was not identified.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1026791
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« Reply #37 on: January 13, 2014, 03:17:24 AM »

Model Number 3387
Device Problems Device remains implanted; Inappropriate shock
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported that the patient had suffered several falls, subsequent to dbs system placement. The patient had swelling between the shoulder and elbow at the area of paresthesia in the patient's upper right arm. A tingling sensation had been detected in the right arm, which became worse with increased movement. The patient visited her physician (date of follow-up was not provided). The device was not reprogrammed and surgery was not anticipated. The patient indicated that product issues were on-going. She also reported she had experienced light shocks that happened infrequently and were attributed to the implanted system. The patient's status was reported as fair. Additional information has been requested from the physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1026786
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« Reply #38 on: January 13, 2014, 08:59:06 AM »

Model Number 3389
Device Problems Device remains implanted; Unit inactivated; Implant, reprogramming of
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The spouse had reported on 11/07, there had never been therapeutic effect when stimulation therapy was turned on, the pt's symptoms had improved (he was better), with stimulation turned off. The hcp provided summary notes for pt follow-up between 2 months in 2007, timeframe. All impedance checks in 2007, has been normal (exact values were not provided), the unilateral dbs system had been reprogrammed several times without improvement. Symptoms of neurological deficit was described as "freezing. " the pt was seen in 2007, for initial reprogramming after dbs placement. Initial settings were 1-, case +, 2. 0 v, 90 unsec. When the voltage was turned up to 2. 5 v the pt had "slight skewed diploia. " subsequent settings were 2-, case +, 2. 0 v, 90 unsec, which caused a "dramatic reduction in dyskinesia. " a follow-up 3 days later, the pt had improved and his medications lasted 2. 5 to 3 hrs, versus 2 hrs. It was noted when medications wore off the pt had difficulty walking; he would freeze and would either hop from place to place, to break the freeze, or he would lean into furniture and drag his legs behind him. When the medications worked, he had dyskinesia. The pt omitted levodopa prior to exam; he had no dyskinesia, his speech was clear and he had not seemed distractible or inattentive. There was mild upper extremity and mild to moderate lower extremity rigidity; he had obvious freezing upon initiating and maintaining gait. The pt could not walk effectively for more than a few feet. During reprogramming, setting were 2-, case +, and the voltage was increased from 2. 0 to 3. 0 v, initially keeping the pulse width at 90 usec with no change seen in tone, bradykinesia, or freezing. When the pulse width was widened to 120 usec, the pt's speech became muffled; he had appeared less attentive while conversing and the pulse width was returned to 90 usec. The pt took his medications, which then showed mild right-sided and moderate to severe left-sided dyskinesia, his gait had been normal with good stride length and balance, with stimulation on. At follow-up on 09/21/07, the pt had suffered a fall that required sutures (no details were provided). Settings at 2-, case +, 3. 0 v, showed some on freezing, his gait became worse when off. Settings of 2-, case +, 3. 5 v, still showed on freezing with improvement. Additional settings of 1+,2-, 2. 0 v, 90 usec, and 185 hz showed no obvious on freezing, there was some residual freezing but his medications appeared to be effective for a longer period of time. The pt would discontinue comtan. Approx 2 weeks later, the pt was seen for "further dbs titration"; symptoms of moderate left-sided and mild right-side dyskinesia were noted. Upon initiating gait, there was slowness to move the right-foot and slight freezing in the right lower extremity (rle). When settings changed from 2. 0 to 2. 5 v, the pt showed significant freezing of the rle upon walking. The voltage was increased to 3. 0 v, and the freezing became worse; subsequently the voltage was decreased to zero and freezing appeared to improve. The anode and cathodes were reversed to (1-, 2+), at a setting of 2. 0 v, and 90 usec, which showed improved gait. The pt was discharged at 2. 0 v, and was referred to physical therapy. A follow-up about 2 weeks later, the pt continued to have difficult freezing, which occurred prominently between doses of levodopa, but had also occurred while on levodopa medication. The symptoms were deemed to be a "side effect of dbs off freezing," which had been less prominent pre-operatively, the on freezing was new. On exam he had moderately severe left-sided and mild right-side dyskinesia; freezing was noted upon gait initiation. His speech was normal. Dbs therapy was inactivated; voltage was set to 0 v and the device was turned off. The pt anticipated travel in the following month. Refer to mr report #3004209178200704569.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1006019
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« Reply #39 on: January 13, 2014, 11:19:14 AM »

Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Disability,Required Intervention
Manufacturer Narrative
 
Event Description
Samii a. "spinal accessory neuropathy after deep brain stimulation for parkinson's disease. " stereotactic and functional neurosurgery 2007, 85(6):296-298. It was reported that the pt underwent staged bilateral subthalamic nucleus deep brain stimulation electrode implantation of a medtronic deep brain stimulation system; the first electrode (model number unk), was implanted in the right subthalamic nucleus. Bleeding occurred from a superficial neck vein just above the right clavical when the tunneler passing device was removed. The bleeding was controlled when the extension was removed and pressure applied. A new subcutaneous tract was created and the extension was implanted. Postoperatively, the pt had right shoulder pain, ecchymosis lateral to the implantable pulse generator, and difficulty raising his right arm (weakness). He was subsequently diagnosed with right spinal accessory nerve injury (palsy), that had been confirmed by neuromuscular electrodiagnostic studies (electromyography and nerve conduction), possibly caused by a stretch injury to the nerve when the subcutaneous tunnel was created for placement of the extension device. Nerve conduction studies conducted six weeks after implant had revealed markedly reduced amplitude of the compound muscle action potential (cmap), from the right trapezius (0. 6mv), compared to the left trapezius (7. 4mv), with similar distal latencies. Needle electromyography had depicted positive sharp waves and fibrillation potentials and acute denervation in the upper, middle, and lower right trapezius was suspected. One month after the procedure, the pt had 2/5 strength in his right shoulder elevation/abduction and atrophy of the right upper trapezius. Six weeks after the procedure, findings from nerve conduction and electromyography studies had suggested a poor prognosis. The pt had electrode implantation in the left subthalamic nucleus 8 months after the first surgery, without complication. Nine months after the procedure, the pt had significantly improved pain, minimal atrophy of the right upper trapezius, and nearly symmetric shoulder strength. Within 1 yr and after extensive rehabilitation during recovery, the pain, shoulder weakness, and trapezius muscle atrophy had nearly completely resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1014500
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« Reply #40 on: January 14, 2014, 12:24:07 PM »

Model Number 7426
Device Problems Replace; Inappropriate shock
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
When the pt turned his stimulation on he experienced a shocking sensation in the right side of his body which lasted 5-7 seconds. It started in his right arm, traveled through his body to right leg and toes, and then disappeared. The symptoms coincided with the car crash. The pt did not feel the shocking after switching to a different pt programmer. The pt also experienced shocking on his left side (see mfg report # 3004209178200805581). The bilateral pulse generators and left sided extension were replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1178930
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« Reply #41 on: January 14, 2014, 12:25:26 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Death   Patient Outcome  Death
Event Description
Journal reference: guehl d, vital a, cuny e, et al. Postmortem proof of effectiveness of zona incerta stimulation in parkinson disease. Neurology. 2008;70(16, pt. 2): 1489-1490. In this study, we report the first pathologically proven case of direct bilateral zi stimulation which dramatically improved the cardinal symptoms of pd in a pt implanted for severe pd 6 years previously and who suddenly died. A man was proposed deep brain stimulation (dbs) because he had severe pd for 13 years that had reached the stage of motor fluctuations with incapacitating levodopa-induced dyskinesia. He was operated on with proven effectiveness during 5 years of follow-up. Reportable event: six years after surgery, the pt was admitted to the hosp for generalized dyskinesia associated with lower leg dystonia, for which the daily dosage of l-dopa was slightly reduced from 700 to 500 mg/day. Thereafter, he exhibited severe incapacitating dystonia of the lower legs that was resistant to apomorphine. Two days later, his dystonia was more diffuse and affected the upper limbs and the trunk. The pt fell into a coma with malignant hyperthermia, suggesting the diagnosis of rhabdomyolysis related to severe incapacitating dystonia. Screening for bacterial infections was negative. The clinical picture was complicated by the occurrence of liver insufficiency and he died from hemorrhage after 2 wks of intensive resuscitation. Our histologic data showed that none of the contacts was located within the stn, probable because we were not able to perform peroperative electrophysiologic recordings to guide the targeting in this subject. The electrodes passed just above the stn and were located within the zi. Therefore, the dramatic improvement in rigidity, akinesia, and tremor appears to be closely associated with zi stimulation. (see scanned pages).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069224
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« Reply #42 on: January 14, 2014, 12:26:16 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 06/20/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the pt experienced a burning sensation in the tongue and forearms. The pt "turned down the system" and the symptoms were reduced. The symptoms returned the following day. The pt also had attempted to turn the device off with his programmer with no improvement. Add'l info has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1077018
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« Reply #43 on: January 14, 2014, 12:26:43 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 06/11/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the patient experienced a loss of therapeutic effect and intermittent tingling in the lips and down the arm. The health professional told the patient they could not find "anything wrong with the device". No outcome was reported. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1078572
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« Reply #44 on: January 14, 2014, 08:22:51 PM »

Model Number 7426
Device Problems Inappropriate shock; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 01/01/2008
Event Type  Injury 
Event Description
When the deep brain stimulator was on, the patient experienced a jolting sensation in his left arm. The patient had used a magnet the size of a license plate to pick up other magnets. The patient was in the clinic at the time of the report. The hcp reported the patient status as 'undetermined'. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1216586
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« Reply #45 on: January 14, 2014, 10:12:32 PM »

Model Number 7428
Device Problems Device remains activated; Inappropriate shock
Event Date 08/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt experienced a quick, minor shock in his arm and hand when therapy was turned on. The deep brain stimulator was in 'soft start' mode. The amplitude had been increased from 0. 5 volts to 1. 9 volts at the last clinic visit. A follow-up report will be submitted if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1176145
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« Reply #46 on: January 14, 2014, 10:12:59 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 09/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the patient was experiencing pain in his arms at extremely low voltage settings on his dbs device. The patient used to get good therapy at 3 volts. Now, the patient can not tolerate the device being set at 0. 1 volts. It was unknown if the patient had recently suffered a fall or trauma. Impedance measurements had not been performed. Troubleshooting was being considered. Additional information has been requested, but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1193446
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« Reply #47 on: January 14, 2014, 10:14:12 PM »

Model Number 7424
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: schuurman pr, bosch da, merkus mp, speelman ld. Long-term follow-up of thalamic stimulation versus thalamotomy for tremor suppression. Mov disord, 2008;23(8 );1146-1153. Thalamic stimulation and thalamotomy for treatment of tremor due to parkinson's disease, essential tremor, and multiple sclerosis were compared in a randomized trial. The symptomatic and functional outcome was studied after 5 years of follow-up. Sixty-eight patients were treated (45 pd, 13 et, 10 ms) by thalamotomy (n = 34) or thalamic stimulation (n = 34). After 5 years, 48 patients were available for follow-up. Reportable event: three stimulation patients experienced arm ataxia. See mfg report 2182207-2008-05826.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1162683
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« Reply #48 on: January 14, 2014, 11:38:19 PM »

Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: bailine s, kremen n, kohen i, et al. Bitemporal electroconvulsive therapy for depression in a parkinson disease pt with deep-brain stimulator. J ect 2008;24(2):171-172. We report the successful treatment of an episode of major depression with psychotic features with electroconvulsive therapy (ect) in a woman with advanced parkinson's disease who had a left subthalamic nucleus deep-brain stimulator (dbs) in place. Electroconvulsive therapy effectively and safely treated the pt's depression without harming the pt or damaging the dbs hardware. We offer additional evidence about the safety and efficacy of electroconvulsive therapy in pts with dbs. Reportable event: after the dbs procedure, she had some improvement in her dyskinesias on the side contralateral to stimulation but continued to experience motor fluctuations, depression and anxiety. She also complained of poor sleep, panic attacks, sob, chest pain, and shaking. She attempted suicide and was admitted to the hospital. On admission, she had bilateral upper extremity dyskinesia and was paranoid. After informed consent for ect was obtained, she received 7 treatments for 3 weeks. A bitemporal electrode placement was chosen to maximize the distance between the dbs electrode, and the ect electrodes. Before the first ect treatment, the dbs currents were turned off, with the voltage set to 0. They remained off for the duration of her hospital stay and were not turned back on. There was no worsening of her parkinsonian symptoms during the acute ect course. She was discharged with psychotropic medications. Post-ect computerized tomography scan revealed no shift in dbs electrode position.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161209
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« Reply #49 on: January 16, 2014, 12:15:15 AM »

Model Number 7428
Device Problem Pocket stimulation
Event Date 10/01/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported the pt experienced a loss of therapeutic effect from their deep brain stimulator. The symptoms were noticed about ten days prior. There was no known incident related to the onset of the symptoms. The physician has had to increase the pt's medications. The pt was seen in the clinic. Movement did not cause changes in the stimulation but palpating the device did cause changes in the stimulation. Palpation of the device pocket and lead extension area caused a sensation down the arm and leg. Add'l info has been requested but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1257496
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« Reply #50 on: January 16, 2014, 12:16:34 AM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient experienced a shocking or jolting sensation down her arm when she reached for something. There was no known incident or accident related to the complaint. The patient had a few falls 'quite some time' before the shocking symptoms appeared. The patient status was reported as 'fair' at the time of the complaint. The patient was seen twice by her hcp since the initial complaint; details of the visits were not available at the time of this report. Additional information has been requested. A follow-up report will be submitted if additional information becomes available. Please see mfr. Report # 3004209178-2008-05453.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1150401
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« Reply #51 on: January 16, 2014, 12:17:35 AM »


Model Number 7426
Device Problems High impedance; Inappropriate shock
Event Date 08/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt fell and a week later experienced a tingling stimulation sensation down the entire right side of her body. The tingling wasn't painful. The sensation occurred 30-40 times in one weekend. The pt also experienced a shocking sensation down her right arm. The pt initially had good therapeutic effects, unaffected by the tingling. Three weeks later it was reported that therapy efficacy was questionable. The hcp was able to replicate the tingling sensation by palpating behind the pt's ear at the lead/extension connection. X-rays were negative. Impedances were greater than 2000 ohms and current was less than 7 microamperes in all possible bipolar electrode and electrode-case combinations of the left deep brain stimulator. The hcp planned to do surgery. Additional info has been requested. A follow-up report will be submitted if additional info becomes available. Please see mfr. Report # 3004209178200805657.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1159115
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« Reply #52 on: January 17, 2014, 08:13:34 AM »

Model Number 7426
Device Problems Pocket stimulation; Implant, reprogramming of
Event Date 12/01/2008
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
The patient had a deep brain stimulator for tremor due to unknown cause (not parkinsons or essential tremor). In late 2008, the patient experienced a loss of efficacy. Symptoms included extreme cramping and tightness in his arm. Two weeks later, the patient experienced a 'stroke-like' episode where he could not speak or move. The patient was hospitalized. Test results did not show a stroke or seizure. The patient regained speech and movement 3 days later. The device was interrogated and reprogrammed. The system was fine, but reprogramming did not improve tremor control. The patient also recently experienced a ;'pinching' sensation in the pocket. The patient was in contact with his hcp. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1299103
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« Reply #53 on: January 17, 2014, 12:27:26 PM »

Model Number 7426
Device Problems High impedance; Device remains activated; Inappropriate shock
Event Date 01/19/2006
Event Type  Injury 
Manufacturer Narrative
 
Event Description
The patient experienced uncomfortable shocking sensation in his jaw and down the side of his face, arm, or leg (it was unclear which body side). The impedances of electrode 0 on right lead was greater than 2000 ohms; the current was 11 microamperes, suggesting an open circuit. The impedance on electrode 0 of the left lead was also greater than 2000 ohms; the current was 7 microamperes, suggesting an open circuit. The hcp palpated all of the implanted components but was not able to reproduce any shocking sensation to the patient. X rays were performed and did not reveal any obvious wire fractures or disruptions. The right-sided deep brain stimulator had a battery voltage of 3. 6 volts and was replaced. The extension was replaced at the same surgery. Additional surgery was being considered if the shocking continued. Please see mfr. Report # 3004209178200900214.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1287236
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« Reply #54 on: January 17, 2014, 12:28:52 PM »

Model Number 7426
Device Problems Inappropriate shock; Implant, reprogramming of
Event Date 05/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that beginning in 2007, the pt experienced a range of "surges" from "mild to one that goes though me that makes me lurch/jump a little bit". The shocking was "not so bad" but as the pt began to keep track, he noticed the shocking/jolting "happening a dozen times a day". The pt had periodic shocks and feelings of electricity in the chest and down the left arm 'emanating from a wire". When the pt used the programmer to check the battery, he "felt a surge of electricity go through me". After experiencing a powerful jolt, the pt feels lightheaded for 10-20 seconds. The pt reported an increase in tremors in the right hand and shaking worse than prior to the implant. The pt stated he had, "reasonable handwriting and now barely able to sign my own name - big scribble". The pt had an appointment with the hcp, although the hcp felt there was no issue with the shocking and, the tremors were a progression of the disease. The pt additionally reported falling and fracturing his right hip, but did not feel it was due to the device, as he was having issues prior to the fall. Impedance readings were done with all monopolar readings within normal limits. Bipolar readings between 0 and 3 were >2000 ohms. X-rays showed no sign of a lead fracture. The battery was found to be at 3. 57 volts. The device was reprogrammed around the 0 contact. The pt had changed his hcp and was scheduled to replacement surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1286581
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« Reply #55 on: January 17, 2014, 01:16:22 PM »

Model Number UNKNOWN
Device Problems Inappropriate shock; Other (for use when an appropriate device code cannot be identified)
Event Date 10/16/2008
Event Type  Death   Patient Outcome  Death
Event Description
It was reported that the day after the neurostimulator was replaced due to low battery the patient experienced a metallic taste in his mouth and tingling in his head, and bilateral upper extremities (left greater than right). The patient also experienced pain. Touching the neurostimulator elicited shocks. The sensations were experienced even when the voltage was turned to zero. An x-ray (2008) was performed. No evidence of discontinuity was noted. A mri (2 days later) noted the leads were in the subthalamic region. The patient outcome was noted as a non-serious injury/illness and death. No date of cause of death was reported. The relationship of the patient's death to the device/therapy or the events reported was not reported. 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=1328112
« Last Edit: February 03, 2014, 01:32:30 AM by dennis100 » Logged
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« Reply #56 on: January 17, 2014, 07:20:02 PM »

Model Number 7426
Device Problems Replace; Inappropriate shock; Unit inactivated
Event Date 01/07/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the pt experienced a shocking sensation while the stimulator was turned on. The surge of stimulation was felt when the hcp pressed the telemetry head of the physician programmer over the ins site. No telemetry had been done when this occurred. The pt denied any recent falls or trauma. The surge went down the pt's arm and the side of the body. No other incidents or changes in stimulation were noted prior to, or since, the event. The pt was seen in the clinic and was in good condition. Additional information received indicated the hcp sent the pt for an x-ray to rule out any fractures in the lead or extension. The x-ray did not show any fractures. Impedances were done and showed no abnormalities. The pt's device was turned off pending further investigation. A battery change was scheduled for 2009. The extension was also replaced. The pt has bilateral systems. The manufacture's device tracking system indicated it was the left side ins and extension which were replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1304662
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« Reply #57 on: January 17, 2014, 10:25:18 PM »

Model Number 7428
Device Problem Electro-magnetic interference (EMI)
Event Type  Malfunction 
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
It was reported the patient experienced a loss of therapeutic effect following exposure to ultrasonic treatment at the dentist. The symptoms were at the neck and arms. The patient was at home and the status was reportedly good. The indication lights were reviewed with the patient and it was determined the stim was turned off. The manufacturer technical agent had the patient turn their stim on and reviewed patient on / off options until the stimulator could be checked by the physician or manufacturer representative.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1354652
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« Reply #58 on: January 17, 2014, 10:25:48 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Type  Malfunction 
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
The patient reporte feeling a surge of electricity down his arm. The stimulator was turning on and off intermittently. The manufacturer representative referred the patient to his physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1354654
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« Reply #59 on: January 17, 2014, 10:27:00 PM »

Model Number 7428
Device Problem Replace
Event Date 02/03/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the stimulator was replaced due to pt reports of change in speech, contraction of right arm and hand, tingling and drawing of the right side of the face and mouth when head turned toward right. When the system is on, a shocking sensation is felt at first then it levels off the symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1325826
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« Reply #60 on: January 17, 2014, 10:28:36 PM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 02/01/2009
Event Type  Injury 
Event Description
The pt was shutting the back window of her car when she received a shock that traveled from her right hand, down her arm, across her chest, to her left arm. The pt was seen by her hcp. Impedances were normal. There was no power on reset. Therapeutic results were fine. Please see mfr. Report# 3004209178200901805. Additional info has been requested. A follow-up report will be submitted if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1344064
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« Reply #61 on: January 17, 2014, 10:29:46 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/01/2009
Event Type  Malfunction 
Event Description
It was reported the patient fell and hit her head a couple of days prior and since then has felt "tingles" in her right arm. Described as a "buzzing. " additional information was requested.

 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1395022
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« Reply #62 on: January 18, 2014, 04:02:52 AM »

Model Number 7428
Device Problems Extraneous radiofrequency wave transmission; Replace; Inappropriate shock; Implant, reprogramming of
Event Date 12/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient experienced worsened tremor. The deep brain stimulator was replaced due to battery depletion. At the clinic visit 1 week after device replacement, the pt experienced improved gait and slightly improved tremor control. The pulse width was increased resulting in complete tremor control to the left side of body. Mild to moderate tremor persisted in the right upper limb and occasionally right leg. The patient experienced right shoulder pain. The patient was treated with ropinirole xl and sinemet. At a clinic visit approximately 1 month later, the patient felt shocking when the device was turned on at an amplitude of 4. 0 volts. Impedances were greater than 4000 ohms on electrode combinations involving electrode #3. The tremor was well controlled at 4. 8 volts, but the patient had deteriorated, slurred speech. Therapy amplitude of 5. 7 volts controlled tremor, but caused right-sided tingling and increased slurring of speech. The pt experienced slight right-sided tingling at 4. 7 volts. At 5. 2 volts, the patient felt slight numbness to the left leg. The ropinirole caused facial dyskinesias. The device was reprogrammed to previous settings (as they were prior to generator replacement). The patient had better tremor control on the right body side on lower settings. The patient's postural stability was similar to that before increasing the settings. The patient's speech was less slurred, but slow at times. The patient ambulated with slow, small steps. The patient's condition was not able to be stabilized with reprogramming. The deep brain stimulator was replaced (b)(6) 2009. The patient was doing well with the new stimulator at the original settings. The nurse mentioned that there was.

 
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1370871
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« Reply #63 on: January 18, 2014, 04:09:09 AM »

Model Number 7426
Device Problems Device remains implanted; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 01/01/2009
Event Type  Malfunction 
Event Description
It was reported that the patient experienced "tingling down his right arm" when cautery used on the left side of the patient's face. Additional information has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1428959
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« Reply #64 on: January 18, 2014, 04:10:25 AM »

Model Number 7426
Device Problems Lead(s), breakage of; Migration of device or device component; Implant, reprogramming of
Event Date 11/01/2008
Event Type  Malfunction 
Event Description
It was reported that the patient experienced chest pain in the middle and right side of the chest while the stimulation was turned, when the physician increased the pulse rate from 4. 5 to 4. 8. The pain subsided when the stimulation was turned off. The voltage was decreased on the left side. The patient was seen a week later, and reported pain in the right side of the back in the thoracic area. No changes to programming were noted. A week later, the patient had a botox injection, which resulted in less pain. The patient reported no "seizure-like episodes". No changes were made. Two weeks later, the patient noted painful contractions in the left forearm and left foot. No changes were made to programming. The patient was going into swimming courses. Several months later, it was reported that the entire system was scheduled to be replaced. X-rays revealed that the connector had been pulled down approximately 3 inches from behind the ear into the next region, and the lead was fractured and there were problems with the impedances. No patient outcome was reported. Reference manufacturer's report #3004209178200903788.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1458863
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« Reply #65 on: January 18, 2014, 01:51:45 PM »

Model Number 7426
Device Problem Replace
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient experienced a loss of therapeutic effect with return of symptoms (tremor of the right hand and arm). The patient was unable to adjust stimulation with their patient programmer or with one sent by loaner/repair. Patient commented on end of life of their implantable neurostimulator. Additional information received reported that the patient underwent a surgical revision of their implantable neurostimulator and was no longer experiencing stimulation problems.

 Manufacturer Narrative
The patient programmer was returned for analysis/repair. The device tested according to specifications. There was no anomaly found. The implantable neurostimulator was not returned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1387040
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« Reply #66 on: January 18, 2014, 01:53:17 PM »

Model Number 7426
Device Problems Intermittent continuity; Implant, reprogramming of
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 Event Description
See mfr# 3004209178200903254. It was originally reported that the pt thought her device was not working and that she was feeling horrible. She does not have a pt programmer. Every time her device was reprogrammed her hips hurt, arms get stiff and she shakes. These symptoms last for several days. The pt felt that her device has never really helped her. It was later reported that her right hand "turns inside out" and it gives her hip problems. She does not know if this was the case of prior to turning stimulation, due to her shaking so much without stimulation. She does have some symptom relief. Her device has been reprogrammed. The pt's device kept turning off. She still does not have a pt programmer. She was still having issues with her device system. Further info is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1458573
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« Reply #67 on: January 19, 2014, 12:11:14 AM »

Model Number IPGNEURO
Device Problem Implant, reprogramming of
Event Date 12/01/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
The pt fell off a bike and injured his right shoulder. Following the fall, the pt experienced a loss of therapeutic effect. The pt's tremor symptoms in his right arm seemed to have worsened and were not getting better with adjustments. The pt also experienced increased pain; the pt had torn his left rotator cup before and the pain after the fall felt like that. The physician wanted to do an mri, but the pt advised him that he couldn't have an mri. After the most recent reprogramming session, it was reported that the pt was getting good relief. The pt was at home. The pt planned to have the device checked by a healthcare professional. Additional info has been requested, a follow-up report will be sent if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1427974
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« Reply #68 on: January 19, 2014, 12:11:51 AM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 03/01/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
The pt fell about a month ago and fractured his hip; the pt was going through medical treatment for the fracture. Following the fall, the pt experienced a loss of therapeutic effect. The pt had more tremors since 2009, especially in his right arm. His left arm normally didn't tremor as much, but was shaking more than usual. The pt was at home. Additional info has been requested, a follow-up report will be sent if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1427975
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« Reply #69 on: January 19, 2014, 12:12:21 AM »

Model Number 7426
Device Problems Loss of power; Suspect EMI
Event Date 04/12/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4). This report is being filed following an internal audit.

 
Event Description
It was reported that while the patient was on the cordless phone, the right side device turned off. The patient also experienced spasms in her right arm. The patient stated the device was not working. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1475687
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« Reply #70 on: January 19, 2014, 12:39:50 AM »

Model Number 7426
Device Problems Inappropriate shock; Implant, reprogramming of
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a lack of therapeutic effect since the time of the implant and felt the symptoms had gotten worse over the past month. The patient symptoms were; dizziness, balance issues, trouble with speech, walking, has stiffness/rigidity, double vision, freezing constantly, weakness, and fatigue. The patient did note that he had been dizzy for the past two years. The patient stated the tremors in the right arm were worse now than before implant. The patient reported a shocking or jolting sensation every time he turned on his "lower: ipg. This resulted in a headache and "racing of heart". The device was turned off and the symptoms were gone about 2 hours later, but the patient's tremors in his right hand returned. Multiple attempts at reprogramming had been unsuccessful and the patient was requesting the leads to be explanted. Please see mfr. Report# 3004209178200904365. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1407420
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« Reply #71 on: January 19, 2014, 04:35:16 PM »

Model Number 7426
Device Problems Lead(s), breakage of; Replace
Event Date 05/18/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported, the patient experienced right sided tingling down the neck and arm. The extension was revised. Upon inspection during the revision, the distal end of the brain lead looked damaged with compromised insulation. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1403241
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« Reply #72 on: January 19, 2014, 04:35:57 PM »

Model Number 7428
Device Problem Inappropriate shock
Event Date 07/01/2009
Event Type  Injury 
Manufacturer Narrative
 
Event Description
It was reported the patient experienced a shocking or jolting sensation randomly in her arm and leg. She additionally reported some pulling sensations that lasted for a few seconds and then goes away. The symptoms have occurred in the bathroom, at the dining table and in a restaurant. There was no correlation between the patient's positions and the symptoms. No further outcome was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1463139
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« Reply #73 on: January 19, 2014, 04:36:44 PM »

Model Number 37612
Device Problem No Information
Event Type  Malfunction 
Event Description
It was reported that the pt's leg went out on them and they fell and hit their head while throwing something over a chair. This was followed by a drawer falling on them. It was also reported that the pt experienced cramping in their torso, arm, hands, and knees to toes. The cramps were alleviated with walking around. The pt had a history of blood clots. Additional info has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1494706
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« Reply #74 on: January 19, 2014, 04:37:48 PM »

Model Number 7428
Device Problem Inappropriate shock
Event Date 07/01/2009
Event Type  Malfunction 
Event Description
The pt experienced a shocking or jolting sensation over the neck area and down his arm. The pt turned the device off until he could be seen by a physician to determine what was going on. Additional info has been requested, a follow-up report will be sent if additional info becomes available.

 
Manufacturer Narrative
(b) (4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1492124
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« Reply #75 on: January 19, 2014, 04:39:09 PM »

Model Number 7428
Device Problem Loss of power
Event Date 07/06/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that the pt woke up feeling "funny". The implantable neurostimulator was found to be off. The implantable neurostimulator was turned back on, however, the symptoms worsened. When stimulation was on, the pt reported a "stronger sensation" than usual. The symptoms began in the pt's arm. There was no known incident related to the event. Additional info has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1485136
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« Reply #76 on: January 20, 2014, 01:04:41 AM »

Model Number 7426
Device Problems High impedance; Inappropriate shock; Low impedance
Event Type  Malfunction 
Event Description
It was reported that the pt experienced a shocking sensation on the left side of their face which travels into hand and arm. The symptoms appeared following a tooth extraction on the right side of the pt's mouth. High and low impedances were reported. Impedances: c/0 >2000 8ua, c/1>2000 9ua, c/2 669 19, c/3 678 19 all bipolar pairs <50 and 223. Programmed c+1-, 2. 6v, 60 185.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1463155
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« Reply #77 on: January 22, 2014, 07:10:30 AM »

Model Number IPGNEURO
Device Problem No Information
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient wished she never had the implant. She had an "air bubble" and "the skin separated from the bones". She had pain in the radial nerve of her left arm and the device made it, so her eyes could not open. The device has since been explanted. Further info is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1590191
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« Reply #78 on: January 25, 2014, 03:41:26 PM »

Model Number 7426
Device Problem No Information
Event Date 08/01/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that while pt was having a biopsy on the left temple (same side as lead -- left stn), the pt felt a tingling down the right arm. Once the cautery stopped, the tingling subsided. The biopsy indicated that further treatment was necessary. It was recommend that radiation would be a better choice and the radiation beam should be directed away from the device. 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=1834607
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« Reply #79 on: January 25, 2014, 03:41:53 PM »

Model Number 7426
Device Problem High impedance
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).

 
Event Description
The impedance measurements were greater than 2000 ohms on all of the unipolar pairs. The patient experienced a tingle sensation in opposite hand/arm when the neurostimulator was on. Further information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1831835
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« Reply #80 on: January 26, 2014, 01:51:30 AM »

Model Number 7428
Device Problem Inappropriate shock
Event Date 06/01/2010
Event Type  Malfunction 
Event Description
It was reported, the patient experienced a shocking or jolting sensation down the left arm. It was stated, the impedances on the patient's device "changed when the doctor reran the impedance test. " the possibility of a fluid short was discussed. The patient's information was not 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=1885252
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« Reply #81 on: January 27, 2014, 08:44:32 AM »

Model Number 7426
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that after replacement the symptom was not improved. It was noted that now the patient was in the hospital. Additional information received reported that the patient did not clarify the device. It was noted that the patient was in the hospital for further observation and they would discuss with the hospital for programming. It was noted that the patient¿s limb and tongue stiffness was aggravated. It was noted that the left body tremble was aggravated.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528574
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« Reply #82 on: January 27, 2014, 08:45:35 AM »

Model Number 7426
Event Date 01/24/2007
Event Type  Injury   Patient Outcome  Other,Required Intervention,Hospitalization
Manufacturer Narrative
Product id 3389s-40 lot# v013803, implanted: 2007 (b)(6); product type lead product id 3389s-40 lot# v014891, implanted: 2007 (b)(6); product type lead product id 7482a51 lot# serial# (b)(4); product type extension product id 7482a51, serial# (b)(4); product type extension product id 7426, serial# (b)(4); product type implantable neurostimulator. (b)(4).

 
Event Description
It was reported that the patient had left basal ganglia infarct during implant surgery. Post-operatively, the patient had mild right arm and facial weakness, and the follow-up ct scan of the brain noted a left basal ganglia lacunar infarct. During the patient¿s time in the hospital, he had post-operative confusion which slowly resolved. His facial weakness and arm weakness completely resolved without sequelae. ¿other¿ intervention occurred. It was resolved as of (b)(6) 2007. See mfr report numbers 2182207-2007-00690 and 2182207-2007-00689 for previously reported information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3531162
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« Reply #83 on: January 27, 2014, 08:46:54 AM »

Model Number 37601
Event Date 07/08/2013
Event Type  Injury   Patient Outcome  Disability
Manufacturer Narrative
Product id 3389s-40 lot# va07vdx, implanted: 2013 (b)(6); product type lead product id 3389s-40 lot# va07vdx, implanted: 2013 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension. (b)(4).

 
Event Description
It was reported, the patient was regressing and their symptoms returned the night prior to this report. It was noted, the patient had an appointment with their healthcare professional on the day of this report. The reporter stated, the patient was adjusted yesterday afternoon and was okay for an hour and then they started to decline until they were completely disabled. It was noted the patient was complaining of symptoms behind their right ear and their arm. It was further noted the patient felt tightening that had improved in their arm, but not behind the ear. The reporter stated the patient had anxiety about their symptoms and they could not move. It was noted the patient was not able to adjust stimulation. It was noted the patient programmer showed a synchronize patient programmer and implantable neurostimulator warning screen. It was further noted the patient placed the antenna over the implant, pressed the sync key, and the warning screen went away. Additional information was requested, but was not available as of the date of this report.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528240
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« Reply #84 on: January 28, 2014, 09:51:23 AM »

Model Number 7428
Device Problem Break
Event Date 10/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: cacciola f, farah jo, eldridge pr, byrne p, varma tk. Bilateral deep brain stimulation for cervical dystonia: long-term outcome in a series of 10 pts. Neurosurgery. Oct 2010;67(4):957-963. Summary: the authors reported on the long-term outcome of their pts with bilateral gpi deep brain stimulation in cervical dystonia. Ten consecutive pts from february 2002 to august 2008 were followed; their mean age was 52. 2 years. On the total twstrs score, an overall improvement was seen; three pts had excellent improvement, 4 were good and 3 were moderate. On the severity subscale score, all pts were classified as responders with a mean improvement of 66. 6%. Three had excellent, 5 good, and 2 moderate improvements. On the pain subscale score, all but 1 pt responded to treatment, with a mean improvement of 58. 3%. Five had excellent, 1 good, and 3 moderate improvement, whereas 1 pt failed to respond. On the disability subscale score, all pts responded with a mean improvement of 80. 7%. Seven had excellent, 2 good, and 1 moderate improvement. Three complications were reported. Reportable event: this report is for one pt who experienced a lead breakage. The lead breakage occurred 1 year after initial placement, resulting in a partial return of the torticollis and mainly the sensation of electrical surges, as reported by the pt from the neck down into the right arm. The electrode was subsequently replaced.

 
Manufacturer Narrative
(b)(4) (no code): torticollis (yes). 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=1913949
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« Reply #85 on: February 07, 2014, 08:31:15 AM »


Model Number NEU_INS_STIMULATOR
Event Date 09/04/2012
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization,Disability
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, lot# unknown product type: lead. Product id: neu_unknown_ext, lot# unknown product type: extension. (b)(4).

 
Event Description
It was reported there was a concomitant left basal ganglia intracerebral hemorrhage (1 x 2cm) that surrounded the left deep brain stimulation (dbs) lead. It was noted intervention included medical or non-surgical therapy. It was stated there was a ct scan without contrast. It was noted the results were expected post-operative pneumocephalus and no new hemorrhage was identified on (b)(6) 2012. It was noted on (b)(6) 2012 another ct scan without contrast was performed and the hemorrhage around the tip of the left dbs was unchanged. It was stated an eeg was performed and the results were independent right and left frontotemporal irregular delta slowing, frontal intermittent rhythmic delta activity which was suggestive of a mild to moderate non-specific cerebral dysfunction on (b)(6) 2012. It was noted an eeg with video suggested dysfunction in the left hemisphere. It was stated on (b)(6) 2012 a ct scan without contrast was performed and the results showed the pneumocephalus had resolved and there was a continued evolution of intraparenchymal hemorrhage that was centered around the left dbs lead and no hemorrhage was seen. Etiology consisted of surgery and anesthesia. It was noted it was not related to the device or therapy but it was possibly related to the implant procedure. It was noted the patient had weakness on right upper extremity and aphasia with a decline in respiratory rate and it was severe. It was noted the event resulted in in-patient hospitalization and prolonged existing hospitalization and persistent or significant disability/incapacity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3591800
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« Reply #86 on: March 29, 2014, 12:04:41 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the patient was extremely uncomfortable with the implantable neurostimulator (ins). The ins did not seem very suitable for her. It was very large and she was very skinny. She had pain in the muscles of the left side of chest right above the breast and she could not use her arm properly. She had a lot of pain in her chest. It was ¿kind of like¿ contracting her muscles when she moved her arm in certain positions. Eating and ¿stuff¿ would cause the muscle to contract and pain. The patient did not feel this uncomfortable with the last ins. It was very difficult for her and she could not eat. The patient was going to talk to her health care professional on (b)(6) 2012. Additional information received reported there was ¿very little¿ the health care professional could do to make the patient more comfortable. It was later reported that the patient¿s first operation was in (b)(6) 2012 and she had had a single ¿big battery¿ implanted but it was too big and coming out of her chest. The patient was slender. Patient had her second operation in (b)(6) 2013 and that was when 2 smaller batteries were put in her chest. It was noted that after this surgery everything was fine. Patient had devices check in (b)(6) 2013 and everything was fine then too.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3640480
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« Reply #87 on: March 29, 2014, 12:05:27 AM »

Model Number 7428
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient was implanted on (b)(6) 2008 due to dystonia. In (b)(6) 2013, the patient had gone to the hospital for programming. It was noted that the patient was told that the product could remain for only 4-6 months. In (b)(6) 2014, the patient had experienced arm numbness and difficulty opening eyes. Additional information received reported the reason for the patient symptoms was unknown and it was unobtainable whether they were related to a device malfunction. It was unobtainable whether this was expected/normal or premature battery depletion. Patient¿s family was considering replacing the product. It was unobtainable whether patient would have replacement of their system. Additional information received reported that the patient was planning to have a replacement operation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3649772
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« Reply #88 on: April 10, 2014, 08:20:05 AM »

Model Number 37603
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
It was originally reported on (b)(6) 2014 that the patient had a hematoma and a patient injury. It was noted a week prior to report the patient had woken up with a neck ache and they went ¿downhill from that point. ¿ it was stated the patient had an injury and they had gone to see their doctor about one month prior to report because of headaches on the side of their head where the leads were. It was stated the patient had a concussion at that time. It was noted the concussion was caused by a fall in their bedroom where the patient had hit their head. It was stated the patient had 3 concussions in their life because they were ¿sort of a klutz¿ and they had fallen recently. It was noted the patient had been hospitalized ¿on a couple of occasions because when they would hit their head their forehead would swell and it was insane. ¿ it was noted the patient might have had a bit of blood there and that¿s why they had headaches. It was stated they may have had a little subdural hematoma that would have created the pain from the leads. Two days later it was reported that the patient was staying at the clinic¿s hotel for the outpatient program at the time of the report. The reporter stated that after implant everything was fantastic and all of her symptoms went away, maybe 95% of them, but then all of a sudden last week they all came back in a 24 hour period and got progressively worse. The patient went to the doctor to reprogram the device ¿on friday and today. ¿ the reporter noted that at previous reprogramming sessions the patient could always feel the doctor reprogramming, such as her arm jerking if it got too high or feeling it in her tongue which would go away, but this time she felt nothing. The doctor tried twice to reprogram it. The reporter noted that the patient had to go in for reprogramming every two months to ¿tweek¿ it a little bit. The reporter stated that they seemed to believe the device was working, they had no reason to believe otherwise, except none of them had seen it come back so fast in such a short time. The reporter stated that ¿something was odd when something stopped working immediately. ¿ the reporter stated that ¿after seven months of absolute perfect to have it all go to hell in one day, something was not right there. ¿ the reporter was assuming that something went wrong or the battery went out or it got turned off. The doctor reportedly told the reporter that the device was working. The patient still had ¿full symptoms going. ¿ the reporter was not sure if they had tested system integrity or not and did not know if they were getting any messages on the patient programmer. The reporter stated that the patient was also in excruciating pain, all within 24 hours. The patient had a concussion two weeks prior to the report. The patient hit her head against the wall, but had no symptoms at that time. The reporter stated that the implantable neurostimulator (ins) was ¿way off to the side, so they could not really set it and it was bugging the hell out of the patient. ¿ the patient was playing with the ins all of the time and trying to make it feel better. The patient pushed the ins from side to side because it ¿kind of rubs against the bone. ¿ the reporter stated that the doctor said the only way to change it was when the ins was changed out the next time. The doctor had not done any x-rays or anything. The reporter was going to talk to the doctor the day after the report. Additional information was requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3677018
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« Reply #89 on: April 10, 2014, 08:21:37 AM »

Model Number 37612
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient had increased stimulation and ¿side effects¿ after going through a theft detector at a drug store. The following day, it was reported that the patient didn¿t have any problem with therapy until (b)(6) 2013, when the patient went through the theft detector. The patient started to feel shocks in his left arm and had blurred vision the day after. Additionally, the battery was checked with the patient programmer which showed a call-your-doctor icon. After recharging the battery to 100%, the shocks ceased. The following morning, the battery had completely run down. It was recharged again and reset by the healthcare provider (hcp) but the shocks continued. Since then, ¿satisfactory results in the treatment was no longer obtained¿. On (b)(6) 2014, after several attempts, it was possible to set the device to obtain the therapeutic results prior to the theft detector incident. Five days after that however, a call-your-doctor icon was displayed again. The patient also started to feel shocks in his left arm and the battery started to run down quickly. The device was reprogrammed twice after that but that did not ultimately remedy the situation. Stimulation was subsequently turned off. The reporter believed that ¿the device was not supporting amplitude pulses greater than 3v since there was discharge and the need to turn the device off and reduce the amplitude¿. Four days later, it was reported that the patient was charging more than expected. The message that accompanied the call-your-doctor icon could not be recalled. It was further reported that the patient also started feeling tingling in his arm after going through the theft detector. It was unknown if it was a power-on-reset (por) that was displayed along with the call-your-doctor icon. The device reportedly discharged within a day and the patient believed there was a ¿failure¿ with it. Diagnostic testing performed on (b)(6) 2014 showed the typical recharge duration was 0. 5 hours and the typical recharge interval was 0 days and the implantable neurostimulator (ins) status was ok. Similar testing done approximately a week later indicated that the typical recharge duration was 0. 4 hours and the typical recharge interval was 0. 2 days. It was also noted that stimulation was off. Cycling had been off in both cases and the patient had been programmed to 0+,1+,2-,3+ and 8+,9-,10-,11+ on the left and right globus pallidus (gpi) respectively. No information on coupling was provided for both tests. There were no out-of-range impedances found. The charge percentage at the end of recharge sessions varied, but were not always 100%. Approximately two weeks later, it was reported that a ¿malfunction¿ was observed but the cause of the issue was not determined. Telemetry was performed and information pertaining to that diagnostic testing was pending. Surgery was going to be performed, details related to this of which were unknown at the time. The patient was not receiving effective therapy. If additional information becomes available, a follow-up report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3702814
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« Reply #90 on: April 10, 2014, 09:29:38 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
(b)(4).

Event Description
It was reported that after a replacement the patient had hallucinations, line of sight blurring, and limb stiffness during the night. The patient went for programming in (b)(6) 2013, but the effect did not improve. The patient called into consult how to deal with it. The following day it was reported that the patient still had hallucinations and limb stiffness.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3662942
« Last Edit: February 07, 2015, 08:58:32 AM by dennis100 » Logged
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« Reply #91 on: May 11, 2014, 08:44:53 PM »

Model Number 37602
Event Type Injury Patient Outcome Other
Event Description
It was reported there was a shocking or jolting sensation. It was noted the patient felt ¿paralyzed in their leg¿ the day prior to report. It was noted they felt ¿paralyzed in their arm and shocking¿ since the implant. It was noted the patient had fallen on (b)(6) 2013. It was stated they had fallen and broken their hip. It was noted the patient had not done well since the fall. It was noted the paralyzed feeling in their leg had not gone away. It was stated their arm would go paralyzed for 8 seconds and then it would stop. It was noted the patient had seen their doctor the week prior to report and no adjustments or changes were made to the dbs settings. It was noted they had requested to not have the dbs raised because it would cause a shocking sensation and it would paralyze them.

Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387-40, lot# l54554, implanted: (b)(6) 1998, product type: lead. Product id: 7495-25, serial# (b)(4), implanted: (b)(6) 1998, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3734588
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« Reply #92 on: May 11, 2014, 10:11:47 PM »

Model Number 37601
Event Type Injury
Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

Event Description
It was reported the patient¿s deep brain stimulation (dbs) device was implanted (b)(6) of 2012 and they could never program it. The leads were implanted and ten days later they put the battery pack in and they waited another ten days before they turned it on to program it. The patient¿s healthcare provider (hcp) could not figure out why on the lowest setting the patient could not talk, his left arm would come up to his chest when he would walk and his right shoulder kept twitching or spasming. From the time it was implanted the device did not really function for the patient; every time they turned it on and gave him medications to try to control the dyskinesia it did not work and this was after a year of oral medication. It was noted the patient was dyskinetic the entire time the device was implanted. It stayed in for about a year until they could not figure out why or what was going on. Every time the patient turned it on ¿patient shoulder would, he was falling three times a day. ¿ the patient fell in his house and broke his ribs the last saturday in (b)(6) 2012. The patient¿s dbs device was turned off and he was better but he still had some of the dyskinesia and had tremendous headaches. In (b)(6) of 2013, the patient had his device removed as he could not handle it anymore. The patient was sure there was a short circuit or something like that which caused the dyskinesia. It was reported the patient thought the leads down in the globus thalamus would not do that, he understood it may affect his speech, but not the rest of it. It was reported the device was leading to such headaches and such problems; he had a big bony growth behind his ear in his skull which was occurring during the entire time the device was implanted. After the device was removed those symptoms went away. Additional information received two weeks later reported somewhere around the second week of (b)(6) 2012 the patient was in severe dyskinesia one night and he could not turn it off. He did not know what was going on and he finally got in touch with a manufacturer representative from (b)(4) who walked his wife through turning his device off. It was also reported the patient¿s unit did not come out easily, the leads and all that stuff did not come out easily. Additional information has been requested but was not available as of the date of this report; a follow-up report will be sent if information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3745721
« Last Edit: February 07, 2015, 09:00:16 AM by dennis100 » Logged
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« Reply #93 on: June 07, 2014, 09:23:29 AM »

Model Number 37603
Event Type Injury
Patient Outcome Required Intervention,Hospitalization
Event Description
It was reported that the patient presented in the last two weeks with enormous edema around one of his two leads. The patient also had some hemorrhage around the contact zone. The working diagnosis was an indolent infection, but the neuro radiologist felt the case looked more like a reaction to the lead, possibly ¿thermal¿ injury. The physician thought the lead may have possibly contributed to the infection. The lead was explanted and would be replaced in the future. Three days later it was reported that the patient was in the hospital because the infection was thought to be a concern. The infection was thought to be down the length of the lead and it was being cultured. The patient reported that last week he went through a metal detector at a courthouse with his system on and since then had been having trouble with his right side system. The patient¿s left arm was shaking badly. The implantable neurostimulator (ins) was not interrogated after the patient went through the metal detector because the lead was removed before they were aware of the issue. It was noted that no shock was mentioned when going through the system. The patient was told by the courthouse employee that the system was totally fine for him to go through after a bypass was requested because it was a ¿new¿ system. The issues occurred on (b)(6) 2014 and the patient went to the hospital the day after. The reporter noted that the therapy had been a huge improvement for the patient. Two days later it was reported that the doctor was concerned a new type of metal detector could possibly create adverse events with patients. The doctor was not sure if the patient¿s problems were caused by the metal detector, but wanted to consider all possible explanations. The patient reported feeling ¿different¿ a couple of days after (b)(6) 2014. A scan showed unilateral edema and fluid accumulation around the lead. The lead culture came back negative for an infection. The doctor was thus seeking alternate explanations and a ¿neuroradiologist¿ told him that it may be a thermal lesion. The doctor speculated and wondered if passing through a security metal detector could cause lesions. The patient was doing very well after explant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3835878
« Last Edit: February 07, 2015, 09:00:49 AM by dennis100 » Logged
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« Reply #94 on: June 07, 2014, 09:24:34 AM »

Model Number 37612
Event Date 05/05/2014
Event Type Injury Patient Outcome Other
Event Description
It was reported there was high impedance of >40,000. It was noted it was unknown what caused the high impedance. It was stated the patient was reprogrammed as a result of the event. It was noted the issue was not resolved. It was stated the patient status at the time of report was alive with no injury. It was noted the patient had seizures. It was noted they tried to reprogram around a lead electrode with high impedance and during the reprogramming the patient had experienced a seizure. It was noted the devices were implanted in an off label manner and use. It was noted the location of the issue was at the left side implant. It was further reported the high impedance did not resolve. It was clarified that this was not a deep brain stimulator (dbs) patient and it was a research patient who had paddle leads placed on their brain to provide epidural cortical stimulation to help treat depression. It was noted it was an off-label research. It was stated the patient was doing fine at the time of report and they left the hospital a short time after the seizure occurred. It was noted they returned to the hospital the next day and the doctor had turned their devices back on. Additional information received reported the patient¿s amplitude on (b)(6) 2014 was increased for a therapeutic delivery of approximately 13 uamps. It was stated the day prior to report the patient¿s mood was 85% of goal. It was noted they had no plans to change anything as the patient¿s mood particularly had turned around for the previous 2 days. It was stated that was until the doctor had seen 1 contact (11) in the right lateral paddle that consistently showed >40,000 for resistance which suggested an open contact. It was noted contact 11 was turned off. It was noted the configuration was changed in the paddle and the therapeutic delivery dropped from approximately 13 to 6. It was noted within minutes the patient began to have facial twitching and clonic movements in their upper extremities. It was noted the patient appeared to have a partial seizure in the doctor¿s office that had stopped within seconds of turning off the right system. It was stated both ins¿ were turned off and they had the patient transported to the emergency department. It was noted they appeared to have partial weakness in their left upper extremity and a facial droop postictal (todd¿s paralysis) that had resolved completely within minutes. It was stated by the time the patient was at the emergency department, they were completely asymptomatic. It was noted the head computed tomography scan (ct) was negative and their basic metabolic panel was within normal limits. It was stated the patient was discharged home. It was noted the patient was seen on the day of report and their mood was pretty good and they didn¿t have the lethargy that the patient had dealt with in the mornings for the past few months prior to report. It was noted the patient seemed to tolerate the current settings. It was stated the patient would be seen one week following report. It was noted the patient had arrived on the day of report without any sequelae.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3835894
« Last Edit: February 07, 2015, 09:01:19 AM by dennis100 » Logged
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« Reply #95 on: July 04, 2014, 09:07:36 PM »

Model Number 37601
Event Date 04/29/2014
Event Type Injury Patient Outcome Required Intervention
Event Description
T was reported there were low impedances of 33 ohms on electrodes 0 and 1. The patient complained of tingling sensation down their right arm at different times. The tingling occurred sporadically and could be reproduced by palpating their chest where the stimulator was implanted. The stimulator was replaced. During the procedure it was clear there was fluid in the head portion of the stimulator. Additional information reported the patient was receiving therapy and had not reported any tingling sensation. It was reported the stimulator had been nearing end of life. It was also noted there was fluid around the pocket of the stimulator. The patient had been experiencing a shocking sensation when touching around the stimulator. The event was noted as resolved without sequelae and not related to the device or therapy and unlikely related to the implant procedure.

Manufacturer Narrative
Concomitant products: product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 3387s-40, lot # va0buyn, implanted: (b)(6) 2013, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3387s-40, lot # v553425, implanted: (b)(6) 2010, product type lead. (b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3869958
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« Reply #96 on: July 04, 2014, 11:51:55 PM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3855294
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« Reply #97 on: August 10, 2014, 06:13:16 AM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# v157349, implanted: 2008 (b)(6); product type lead product id 7482a66, serial# (b)(4), implanted: 2008 (b)(6); product type extension (b)(4).

Event Description
It was reported a few days following the patient¿s replacement surgery, they noticed a tingling on their chest as well as up and down their right arm. It was noted, the lead was in the left ventral intermediate nucleus (vim). The patient¿s right hand and arm would kind of go into a ¿flailing mode¿ and it would affect their motor coordination. It was described as intermittent shocking symptoms. The old implantable neurostimulator (ins) was at the exact settings but at a lower amplitude. An electrode impedance test was performed and c0 showed high at 2360 ohms. It was noted the intermittent shocking occurred a few times a day and they could reproduce it if the patient pushed on the ins. When the patient pressed on the ins the impedance test was redone and c0 showed 1217 and the tingling sensation faded. It was noted the issue appeared with 0. It was further reported on the day of report in the operating room they tried to re-enact the impedances but it showed normal the entire time. It was noted the doctor went ahead and replaced the ins on the day of report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3922599
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« Reply #98 on: September 06, 2014, 12:40:01 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Patient Outcome Required Intervention
Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Concomitant medical products: product id: 3387, lot# unknown, product type: lead. (b)(4).

Event Description
Sriram, a. , foote, k. D. , oyama, g. , kwak, j. , zeilman, p. R. , okun, m. S. Brittle dyskinesia following stn but not gpi deep brain stimulation. Tremor and other hyperkinetic movements (new york, n. Y. ). 2014;4:242. Doi: 10. 7916/d8ks6ppr summary: the aim was to describe the prevalence and characteristics of difficult to manage dyskinesia associated with subthalamic nucleus (stn) deep brain stimulation (dbs). A small subset of stn dbs patients experience troublesome dyskinesia despite optimal programming and medication adjustments. This group of patients has been referred to by some practitioners as brittle stn dbs-induced dyskinesia, drawing on comparisons with brittle diabetics experiencing severe blood sugar regulation issues and on a single description by mclellan in 1982. We sought to describe, and also to investigate how often the ¿¿brittle¿¿ phenomenon occurs in a relatively large dbs practice. An institutional review board-approved patient database was reviewed, and all stn and globus pallidus internus (gpi) dbs patients who had surgery at the university of florida from july 2002 to july 2012 were extracted for analysis. There were 179 total stn dbs patients and, of those, four stn dbs (2. 2%) cases were identified as having dyskinesia that could not be managed without the induction of an ¿¿off state,¿¿ or by the precipitation of a severe dyskinesia despite vigorous stimulation and medication adjustments. Of 75 gpi dbs cases reviewed, none (0%) was identified as having brittle dyskinesia. One stn dbs patient was successfully rescued by bilateral gpi dbs. Understanding the potential risk factors for postoperative troublesome and brittle dyskinesia may have an impact on the initial surgical target selection (stn vs. Gpi) in dbs therapy. Rescue gpi dbs therapy may be a viable treatment option, though more cases will be required to verify this observation. Reported event: one (b)(6) male patient experienced right upper extremity and right lower extremity dyskinesia at both the 1 and the 2 contacts on the deep brain stimulation (dbs) lead following left-sided subthalamic nucleus (stn) dbs implant. It was noted that the 1 and 2 dbs lead contacts corresponded to the best therapeutic benefit during programming sessions. The reporter stated that multiple programming strategies were employed, including attempts at slow stimulation titrations, and the use of a more dorsal dbs contact site. Reportedly, the dyskinesia only abated when the dbs was turned off. It was noted that attempts were made to commensurately decrease carbidopa/levodopa dosage in combination with stimulation changes, but this reportedly worsened the patient¿s off state, though at low medication dosages dyskinesia abated. The reporter stated that the patient experienced a similar clinical scenario when the right stn dbs was added. Reportedly, at settings that improved his freezing of gait, the patient had bothersome left lower extremity dyskinesia. It was noted that many other attempted settings failed to capture his gait freezing and the off symptoms. The reporter stated that the patient underwent rescue bilateral staged globus pallidus internus (gpi) dbs in a single operative sitting, and following programming, the dyskinesia completely abated, and the patient was able to maintain a smooth on medication state. The source literature included the following device specifics: lead model 3387 further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3976613
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« Reply #99 on: September 06, 2014, 12:40:43 AM »

Model Number 7426
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported a couple of months prior to report the patient started to have a shocking sensation down their right side and right arm. The patient had high impedances and they could not isolate it to anything. Both of the patient¿s batteries were near depletion so they replaced both devices in may and everything cleared up, including impedances.

Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 3387-40, lot# v004947, implanted: (b)(6) 2006, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 3387-40, lot# v004947, implanted: (b)(6) 2006, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3999542
« Last Edit: February 07, 2015, 09:03:23 AM by dennis100 » Logged
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« Reply #100 on: September 06, 2014, 12:41:30 AM »

Model Number NEU_UNKNOWN_LEAD
Event Date 06/04/2014
Event Type Injury
Patient Outcome Hospitalization,Life Threatening,Required Intervention
Manufacturer Narrative
Product id: neu_unknown_ext, serial# unknown, implanted: (b)(6) 2014, product type: extension. (b)(4).

Event Description
It was reported that the adverse event was right corona radiate infarct. It was noted that at the time of report it was unknown if the patient planned to complete deep brain stimulation (dbs) procedure. It was noted that the outcome was resolved without sequelae on (b)(6) 2014. It was noted that interventions included medical or non-surgical intervention including warfarin and phenylephrine infusion on (b)(6) 2014. It was noted that diagnostic methods included a nih stroke scale evaluation with a score of 5 and an mri without contrast showing no indications of stroke or hemorrhage on (b)(6) 2014. It was noted that and mri with contrast showed right corona radiate infarct a day later. It was noted that the etiology included surgery/anesthesia. It was noted that the event was not related to the device or therapy and was related to the implant procedure. It was noted that during lead placement the patient became sleepy, dysarthric with left facial droop and left upper extremity weakness. It was noted that the severity was severe. It was noted that the event resulted in in-patient hospitalization. It was noted that the event was a life threatening situation. Additional information was requested but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3976485
« Last Edit: February 07, 2015, 09:03:45 AM by dennis100 » Logged
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« Reply #101 on: September 06, 2014, 01:43:00 AM »

Model Number 7426
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported a couple of months prior to report the patient started to have a shocking sensation down their right side and right arm. The patient had high impedances and they could not isolate it to anything. Both of the patient¿s batteries were near depletion so they replaced both devices in may and everything cleared up, including impedances.

Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 3387-40, lot# v004947, implanted: (b)(6) 2006, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 3387-40, lot# v004947, implanted: (b)(6) 2006, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3999542
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« Reply #102 on: September 06, 2014, 01:43:41 AM »

Model Number 37601
Event Type Injury
Patient Outcome Hospitalization
Event Description
Additional information received reported that there was a 50% or greater symptom reduction. The cause of the event was not determined, but it was not device related and did not require reprogramming. The patient was hospitalized due to disorientation and confusion. The patient was in a group home setting as well. No interventions or action were taken and the patient outcome was unknown.

Manufacturer Narrative
Concomitant medical products: product id 37601, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3389s-40, lot# v333543, implanted: (b)(6) 2009, product type: lead; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389-40, lot# l75963, implanted: (b)(6) 2000, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 7495-25, serial# (b)(4), implanted: (b)(6) 2000, product type: extension. (b)(4).

Event Description
An emergency room (er) doctor reported that the patient had a sudden loss of therapeutic effect as it happened within the past one or two days. The patient presented to the er on the day of the report with decreased alertness and tonic-clonic tremors in his arms and legs. The symptoms were worse on the left side than the right. The patient¿s wife felt like this was a return to baseline symptoms for him. It was requested that a manufacturer representative come check the patient¿s system as there was no patient programmer available. No patient intervention or outcome was reported, so additional information was requested. If additional information is received a supplemental report will be sent.
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3999664
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« Reply #103 on: September 06, 2014, 06:15:17 AM »

Model Number 37612
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37092, lot# 337540001, implanted: (b)(6) 2012, product type: accessory; product id 3 708695, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387s-40, lot# va01mbs, implanted: (b)(6) 2012, product type: lead; product id 3708695, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387s-40, lot# v992702, implanted: (b)(6) 2012, product type: lead; product id 37651, serial# (b)(4), product type: recharger; product id 3387s-40, lot# va01mbs, implanted: (b)(6) 2012, product type: lead; product id 3387s-40, lot# v992702, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
It was reported the patient recently had battery replacement surgery and the first implantable neurostimulator (ins) had lasted 23 months. The patient had been implanted now with a rechargeable ins and they experienced some problems. The new device was ¿cross-wired¿ when it was implanted but it was ¿not that big of a deal. ¿ the battery was implanted backwards. It was stated the battery was flipped and the problem was resolved with programming. The patient felt like the ins was going on and off and they felt an electrical charge down their right side fairly often and they were not talking as well or doing as well as with the previous deep brain stimulator (dbs). The patient was never able to charge up passed 75%. They suspected there was a problem with the battery. When the patient charged the day prior to report their ins battery level started at 50% and they had all 8 coupling bars. The patient tried to recharge the ins for ¿half a day¿ and they never got passed 75%. The patient did monitor while they recharged and would reposition the antenna to get 8 coupling bars. There was nothing ¿medically wrong¿ with the patient. It was further reported it ¿sounded¿ like the surgeon switched the left brain extension and the right brain extension during the battery exchange so the patient was doing poorly because the settings for the left were in their right brain and vice versa. The patient¿s doctor had switched it back during reprogramming and they felt much better. The patient was scheduled to go back to see their neurologist soon. Additional information received reported since the change out they had times when they would get an overstimulation feeling that was not associated with movement. They would also get it when they recharged, typically 20 minutes in. However, it was noted to have happened immediately on the day of report when they were in the office with the manufacturer representative and it gave them a dyskinetic feeling. They would get the same overstimulation feeling with telemetry. The impedance measurements were normal. The patient was too sore for palpation. It was further reported the patient was a high energy user. They had recharged the implant for 8 hours and could not get to 100%. It was further reported the patient tried to charge the ins the night prior to report and it overstimulated her. It was noted the ¿whole right side was jumping. ¿ they felt like the stimulation was going on and off by itself. The current would go down their right side and it was the same feeling as when their doctor would program her. They were reprogrammed the week prior to report by their doctor and it worked for a little while. It was stated the non-rechargeable device had worked good but the rechargeable one had not worked well since the implant. It was not a programming issue but the battery did not work correctly. The device would overstimulate the patient and their arm would jump. Additional information received reported the patient had dyskinesia when they would recharge. The patient was given an expanded ability to reduce their stimulation while they recharged so they could charge without major dyskinesia. This allowed the patient to finally reach 100%. There was also a complaint about the patient¿s voice but it seemed the same on and off so they guessed it might be just the progression of the disease. The patient agreed that they were doing very well with their therapy and they were charging fine at the time of report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4030799
« Last Edit: February 07, 2015, 09:04:58 AM by dennis100 » Logged
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« Reply #104 on: October 12, 2014, 04:17:17 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that the patient experienced a shocking or jolting sensation. After an upgrade to a rechargeable implantable neurostimulator (ins), the patient experienced shocking and jolting down their right arm. Impedance testing was performed and all measurements were within normal ranges. It was noted that the patient required fairly high amplitudes to control essential tremor. Amplitude was decreased, which resulted in a ¿less extreme¿ shock. The patient was programmed in bipolar mode in both hemispheres. The ins was implanted in the left pectoral region. The patient reported the shocking sensation was similar to what was felt when stimulation was being switched from off to on. Postural changes did not seem to cause or alleviate the shocking. The patient was admitted to the hospital. Stimulation to the left brain was decreased from 5. 4 v to 4. 0 v, after which the patient no longer experienced the shocking sensation, but the patient then experienced compromised therapy to their right side. Impedances were checked again and were still within normal ranges. Impedances were as follows: c<(>&<)>0 868, c<(>&<)>1 820, c<(>&<)>2 883, c<(>&<)>3 498, 0 <(>&<)>1 1168, 0<(>&<)>2 1353, 0<(>&<)>3 1097, 1<(>&<)>2 1168, 1<(>&<)>3 1016, 2<(>&<)>3 1022, c<(>&<)>4 846, c<(>&<)>5 698, c <(>&<)>6 692, c<(>&<)>7 736, 4<(>&<)>5 907, 4<(>&<)>6 1068, 4<(>&<)>7 1168, 5<(>&<)>6 768, 5<(>&<)>7 968, 6<(>&<)>7 816. Therapy impedances were also measured and within normal ranges. Exploratory surgery was performed on (b)(6) 2014. Impedances were again tested on the left brain lead and both extensions and all impedances were within normal range. The ins and pocket adaptor were explanted and replaced. Since the replacement, the patient had not experienced any further shocks. The patient recovered fully.

Manufacturer Narrative
Concomitant products: product id 64002, product type adapter. (b)(4). Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4103211
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« Reply #105 on: October 13, 2014, 12:22:35 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v230715, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. (b)(4).

Event Description
It was reported that the patient had a stimulator in her chest for essential tremors with parkinson¿s. There was a loss of therapeutic effect. There was a sudden onset of symptoms. Onset was following the patient¿s neighbor had started up a lawn mower while the patient was sitting outside reading a paper and it was so loud and the patient had not known until it was too late, the damage had already been done. The patient had not gone anywhere when this had occurred on the day prior to the date of this report, she had not even left the house. Patient symptoms included tingles down her arm, legs and face, a dull ache in her left ear that she had after surgery and it was back the time of this report and hearing issues. The patient was right handed and the implant was in her left chest. The patient¿s right hand was usually very steady, but was shaking at the time of this report. The patient was unable to hold a toothbrush, fork, a pen or anything. The patient checked her device and it said on with a black triangle and the patient checked again and it said on and ok. The patient had checked her device twice on the day prior to the date of this report to make sure she was on and it was. There had been no problems with the patient¿s previous stimulator, which the patient had for 5 years before having it replaced and the current stimulator had been nothing, but problems/issues. The patient had issues with it since (b)(6) 2014 when it was implanted. The patient looked as though she had a pack of cigarettes sticking out of her chest and the wires looked like they were sticking out of her neck and had not before. The incision was healed and there was no tenderness or redness over the scar. Prior to (b)(6) 2014, the patient had been getting control of her symptoms, but it had been sending her into circles, which meant she was dizzy and had shakes in her right and left hand and pin pricks all over her legs and arms. A healthcare professional had instructed her to turn stimulation on and leave it on and not to turn stimulation off at night in order to prevent side effect. The patient would experience the ¿circles¿ when she had the device off and turned it back on. No interventions or outcome were provided regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4078338
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« Reply #106 on: October 13, 2014, 02:06:17 AM »

Model Number 7426
Event Type Malfunction
Event Description
It was reported that the patient was complaining of the device spontaneously turning off. The device was turned back on at the healthcare providers (hcp) office. Testing was completed including battery voltage and impedances and both were normal and within range. Reprogramming was also completed. Before the patient left the office, the device had turned off again. Then it was then turned on, as well before the patient left. When the patient was home, the device powered of again, and then the patient turned in back on with his hand held patient programmer. The patient status at the time of report was alive with no injury. It was later reported that the patient was having trouble with holding silverware to have breakfast the morning of the report due to his hand shaking. The patient noted that (b)(6) his hands were shaking more and then got relief in the right hand by adjustment. It was then reported that a battery was purchased for the patient programmer, the ins was off, and then the patient turned stimulation back on. The patient felt a shock in his arm, which was noted to be normal when the implant was turned back on. Then, the patient was getting control of his hand again and was receiving effective therapy.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v354660, implanted: (b)(6) 2009, product type: lead. Product id: 7438, serial# (b)(4), product type: programmer, patient. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4078222
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« Reply #107 on: October 13, 2014, 02:07:04 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient was in a car accident 5-6 weeks prior to report. For the following 2 weeks after the accident, the patient felt tingles in their body, but the therapy was still good. Then after the 2 weeks, the patient had a shock in their right arm and on the right side of their body and the therapy was lost. The programming neurologist had scheduled an exploratory surgery on the day of report because of lowered impedances and the implantable neurostimulator (ins) went dead. Their tremor came back everywhere. The left therapy impedance was 82 ohms with a ¿high current¿ and the right therapy impedance was 1,984 ohms. It was noted there could still be an issue with the left lead after they closed up just based on the patterning of impedances. Additional information reported impedances were taken at default and the patient was feeling stimulation when they did so they did not increase to 1. 5v. An ins longevity calculation was performed and it showed 15 months. The patient was getting better therapy than ever, even before the accident. Further follow-up is being conducted to obtain more information. Left lead electrode impedance: c0 2922, c1 1402, c2 922, c3 844, 01 2899, 02 3194, 03 3112, 12 1548, 13 1517, 23 210; right lead electrode impedance: c8 2879, c9 3943, c10 2320, c11 1425, 89 5835, 810 4857, 811 3849, 910 5441 911 4593, 10 11 2883.

Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v407602, implanted: (b)(6) 2010, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4072456
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« Reply #108 on: November 07, 2014, 11:07:06 PM »

Model Number 7426
Event Type Injury
Event Description
It was reported that the patient was seen last in (b)(6) 2013 and they would be seen by their clinician 2 days following report. The electrode impedances were measured and they were all fine and normal. The ins that was implanted on their right chest had a slight tingling sensation to their arm. Additional information received reported the patient still had concerns with their device or therapy, but they were working with their manufacturer representative or doctor. It was stated they had an appointment scheduled for (b)(6) 2014. Additional information received reported there was a 50% or greater symptom reduction. It was later reported that the patient was scheduled to have both of the implantable neurostimulators (inss) replaced on (b)(6) 2014. The patient was seen on (b)(6) 2014 for adjustment and reprogramming. The right stimulator was interrogated and the patient had mild paresthesia in the left arm. Right side settings were at 4. 1v, 90usec, 185hz, and 3+2- with minimal tremor in the left arm. The patient was seen on (b)(6) 2014 and there was no evidence of discontinuity of the leads of extensions. The patient¿s was also seen on (b)(6) 2014 for a device adjustment, weakness and gait difficulty. The weakness onset had been gradual and occurring in a persistent pattern for 4 months prior to the appointment, but had first occurred more than 40 years of age. Weakness had been characterized as difficulty arising from a chair, climbing stairs, walking, and increased weakness following exertion and at the end of the day. Weakness was located in the legs and on the right side only. It was associated with numbness. Patient had falls, difficulty ambulating and a gait disturbance. Onset for gait issues had been gradual starting about 8 months prior to the appointment, but was worsening. The patient had slow speech, romberg sign positive, impaired toes, and was tandem walking impaired which were noted during a physical exam. The patient was still experiencing frequent shocks with the battery with fluctuating responses of the battery. The patient was going to be scheduled for a neurosurgery appointment for a battery change. For numbness and tingling, low back pain and right leg weakness an electromyography (emg) and computerized tomography (ct) were going to be performed. Reference manufacturer¿s report number: 3004209178-2014-12463 for the patient¿s other implanted system and the shocking issues that were isolated to that system.

Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 3387s-40, lot# v368056, implanted: (b)(6) 2009, product type: lead. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210587
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« Reply #109 on: November 07, 2014, 11:33:18 PM »

Model Number 37601
Event Date 10/14/2014
Event Type Injury
Event Description
It was reported that the patient experienced weakness in their arm while waiting to be discharged after an implantable neurostimulator (ins) replacement surgery. The patient was admitted to the hospital for further testing and was to be examined for a potential stroke. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

Manufacturer Narrative
Product id 37085-60, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v383702, implanted: 2010 (b)(6); product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4215823
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« Reply #110 on: November 07, 2014, 11:34:38 PM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the patient had the second surgery for deep brain stimulator. The left side neck was hurting but this was due to head resting on neck before having the implantable neurostimulator (ins) put in. Patient¿s left side head was leaning on his neck and was going down. It was noted that the right side was bended. The ins would be turned on friday following the date of this report to see if the patient would be able to sit up straight and walk upright. The ins was not on yet. It was later reported that the patient¿s neck was still tipping to the side when he walked. Patient was implanted with deep brain stimulator first on the right and then on the left. Patient was still in pain and had numbness in his fingers and had since right after the implant surgery. Neck was still tipping to the side and it causes the patient depression. Patient leaned to the left. Inquired when the patient would begin to see results regarding his neck and ribs. Since implant the patient¿s neck had gone down and he was in a lot of pain. Patient had a follow-up appointment scheduled for the day following (b)(6) 2014. Since patient¿s last surgery on (b)(6) 2014 he had terrible neck pain. The patient¿s neck was hanging to the left and pain was going from the back of the neck down his back. It was noted that prior to this implant the patient was getting botox shots in his neck every 3 months which helped with the pain and he was able to keep his head up. Patient had two devices implanted on (b)(6) 2013 and (b)(6) 2014, the issues with the neck had been since the (b)(6) 2014 implant. Since implant the patient¿s symptoms had shown no improvement. Patient¿s body was not agreeing with the implantable neurostimulators (inss) and patient wanted to receive the operation to cut some of the muscle so it had expansion. It was noted that at the time of this report and before implant the patient¿s head touched his shoulder and when he lifted it up it pulled back down and he had bad pain in his shoulder blades. The patient walked a little slanted and half of his ribs were like round. Prior to implant the patient had had issues with his neck and that was the reason for getting the deep brain stimulator. It was noted that ¿all this time¿ his head was still the same. The deep brain stimulator was bothering him, he did not go outside or do anything. On (b)(6) 2014 the patient had an appointment with a healthcare professional who cuts muscles to give the head an opportunity to be straight. Patient wanted the device taken out but was told it was not going to be taken out. It was noted that every 4 years they had to cut him to change the battery and the patient had two devices and the patient did not understand why they would not do it. Patient felt the lead coming up from his neck to his skull. The patient still walked lopsided and head was still down and the patient still experienced the same symptoms he had prior to the implant. It was noted that the left side was real hard when he touched it coming down his neck and into his skull, it hurt a lot. The left side arm, shoulder and all the way down to his fingers was painful and went to sleep and the patient had to rub icy hot on it. This had been occurring for a couple of months prior to the date of this report. It felt tight and like blood was not flowing the way it should. The patient¿s whole arm went to sleep on him and when he was sleeping and it happened he would have to use his right arm to move his left arm. Arm was painful. The healthcare professional did not want to interfere with the lead the patient had implanted. Additional information received reported that the patient had the device for dystonia. The patient had numbness in the fingers, pain in the neck and their neck tipping was a part of their dystonia and was not device related. The patient also had comorbidity of depression and anxiety. The device had been implanted to try and help the patient and had been prescribed prior to patient being able to be considered for a surgery to remove a nerve in his neck. The deep brain stimulator did not seem to be working for the patient¿s issues. There was nothing wrong with the system, no impedance issues and it worked as designed. The patient wanted the device removed, it had not been decided what to do. The patient had some mental issues so he did not understand the therapy. The patient had thought that with the device he would have no more pain. The patient had not event gotten a little straightness in his neck and was not walking straighter, the patient was very upset and wanted to get better. It felt funny under where the device was which had started 2 months after implant. The pain was waking the patient up. The pain would be in his right arm and then a couple of days later it would in his left arm and the patient would have to use his opposite arm to move his arms. It was noted that the patient had gotten a second opinion and was told the pain was from the device and that something had been done wrong. The patient was told that ¿they had gone from 1 to 1000 instead of 1,2,3,4. ¿ the patient had not felt like himself and was very uncomfortable with the device. The patient¿s healthcare professional was going to remove the device during the month of this report but the patient was just told they would wait till after the other operation instead. Reference manufacturer¿s report number: 3004209178-2014-20672.

Manufacturer Narrative
Product id 37603, serial# (b)(4), implanted: 2014 (b)(6); product type implantable neurostimulator product id 3387s-40, lot# va0ery5, implanted: 2014 (b)(6); product type lead product id 37603, serial# (b)(4), implanted: 2014 (b)(6); product type implantable neurostimulator product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3387s-40, lot# va0ccdl, implanted: 2013 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension. (b)(4). It was unclear whether the device was indicated for use with dystonia or parkinson¿s.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4214508
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« Reply #111 on: November 08, 2014, 12:36:15 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported that the pediatric patient was implanted without the mother¿s consent after he was born in 2010. The mother claimed it was implanted for a study and ¿she was threatened if she did not have the procedure done for her son. ¿ she originally stated that all she wanted to know was what the device was and how to get it out of her son because she did not agree to have it implanted. The mother stated that she could not leave her son around any routers, computers, 4g cellphones, or gps systems because if he got near them ¿he stood straight up like he was being electrocuted, his face began to change to a purple-red coloration, and his arm began twisting and contorting. ¿ he could not be taken to doctor¿s or lawyer¿s offices because the electronics there could cause the symptoms. The mother also claimed that the device was being controlled remotely and that radio waves had been used on it. Her son could walk and talk when the device was off, but ¿when you turn the stimulator on he could not do anything. ¿ the mother also mentioned that the implanted device was ¿expired¿ and had ¿(b)(6) gel in it or on it. ¿ she had taken her son to many neurosurgeons and neurologists, even though the primary doctor refused to seek a second opinion, but no one wanted to him because he was involved in the study. The mother provided x-rays of the implanted device. She stated that her son ¿was going to die because of this¿ and had a ¿class four brain bleed, hydrocephalus,¿ and another disorder that could not be understood. She would not comment on what her son was diagnosed with that could lead to death. The mother was very difficult to follow and it was unclear what was factual or not.

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_ext, serial# unknown, product type: extension. Product id: neu_unknown_lead, serial# unknown, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4185990
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« Reply #112 on: November 08, 2014, 01:58:26 AM »

Model Number 7428
Event Type Injury
Event Description
It was reported that the patient experienced infection due to skin breakdown at the lead site in (b)(6) 2013, three years after implant. There were no other signs or symptoms of infection. The right lead was cut and explanted. The hcp ¿got the lead stopped working¿ and ¿wrapped it in the plastic tube. ¿ the infection resolved. On (b)(6), the patient¿s limbs became rigid and the patient suspected the left lead had stopped working. It was found that the implantable neurostimulator (ins) was off. The ins was turned on and reprogramming was performed. The patient was ¿good¿ after reprogramming.

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, serial# unknown, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4182435
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« Reply #113 on: November 08, 2014, 08:45:42 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant product: product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator. (b)(4).

Event Description
It was reported that around (b)(6) 2013, the patient¿s symptoms had gotten worse, they had tremor on their right side, and their limbs were distorted. After the implantable neurostimulator (ins) was implanted on the right side the patient¿s symptoms on their left side were controlled well. The patient was then implanted with an ins on their left side to control the symptoms on the patient¿s right side. On the same day the patient¿s healthcare professional adjusted the target position of the right ins. Following surgery the patient felt the left ins was heavier than the right ins, but the symptoms were controlled well. On (b)(6) 2014, the patient¿s limbs were trembling, their joints were distorted and their symptoms had gotten worse. The patient was reprogrammed on (b)(6) 2014, but their symptoms did not improve. Follow up with a manufacturing representative indicated that the cause of the event was not determined and it was unknown if intervention was done or if the patient was receiving effective therapy. No interventions or outcome were reported regarding this event. Additional information could not be obtained. Should additional information be received the event will be updated. Refer to manufacturer report #3004209178-2014-18342.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4144132
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« Reply #114 on: November 08, 2014, 08:46:23 AM »

Model Number 37602
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3389-40, lot# j0340291v, implanted: (b)(6) 2003, product type: lead; product id 748295, serial# (b)(4), implanted: (b)(6) 2005, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389-40, lot# j0337392v, implanted: (b)(6) 2003, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. (b)(4). F.

Event Description
It was reported that the patient was having spasms in her hands and arms on the night prior to the date of this report. The patient had used her medic alert necklace on the day prior to the date of this report. The necklace was taken off on the morning of the date of this report and the patient had not had spasms in her hands and arms. The patient was going to try and put the necklace back on to see what would happen. No outcome was provided regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted. Reference manufacturer¿s report number: 3004209178-2014-18142.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4134805
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« Reply #115 on: December 05, 2014, 08:53:52 AM »

Model Number NEU_UNKNOWN_LEAD
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2014, product type: lead. (b)(4).

Event Description
It was reported that the patient had experienced deficits just prior to placing the left side lead during a stage 1 procedure for a deep brain stimulator. The right lead had already been successfully placed just prior to the left lead. The patient had been opened up to place the lead into the left globus pallidus (gpi) when the healthcare professional had noticed deficits which included a weak right arm and the patient was not coherent. Surgery was stopped and the left side was capped with a burr hole cap without placing the lead and patient was closed up. The right lead was kept in. The healthcare professional suspected an intra-operative stroke. The patient had a computerized tomography (ct) scan and the ct was negative and the patient¿s deficits were rebounding, the patient knew what city they were in, was able to identify his wife and was able to squeeze hand more. They planned on doing an mri. Follow up information was received from the manufacturing representative two days after report and no mri had been done. It was unknown if any further troubleshooting was done or if the cause of the event was determined. It was also unknown how the patient was doing and at this time there were no further places to attempt to place the left side lead again. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received, a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4276892
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« Reply #116 on: January 10, 2015, 12:40:53 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4366231
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« Reply #117 on: January 10, 2015, 03:13:03 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the patient had unilateral lead placement to control tremor with good response initially. It had been observed that after 4 to 6 weeks, the patient experienced ¿rapid habituation¿ of the current, and their tremor returned within 4 days and it was ¿to the same extent that it was prior to the device¿ but ¿not as bad as the refractory tremor. ¿ this had reportedly been a ¿constant cycle¿ and became a concern as the patient reached 6v in bipolar mode and "bordered on" the patient experiencing a ¿capsular effect. ¿ this ¿capsular effect¿ was clarified to mean ¿voice, speech, double vision as well as a hot and cold sensation. ¿ other experiences that had increased since having the device included tremor, inbalance, headache, arm aching, ¿clammy hands¿, contracture of the hand, exhaustion from tremor and inability to hold cutlery. It was also noted that when the patient¿s device was turned off, he had a ¿severe¿ refractory tremor, far worse than it was prior to the device. This was ¿so violent¿ that it could only be turned off for a minute. There had been no falls or trauma prior to noticing this. The physician feared that it could be morphology of the disease. The reporter indicated that initial thresholding was done but electrode configuration had remained the same at a setting of 90's, 130 hz on electrode pair 0-,1+. The amplitude had been increased from 2. 2v to 6. 4 in several increments. Threshold testing had been performed again, but to no avail. All electrode and therapy impedances were normal for all testing done with the patient in a rested position, arms up and head to the side. Additionally, no error messages had been observed on either the clinician or patient programmers. The patient was admitted to the hospital for further tests and was placed on constant current mode at 4. 6a under observation. A ct scan was performed which showed ¿perfect lead placement within the proposed target. ¿ the patient had also undergone ¿some more testing¿, details of which were not available at the time of the report. The patient had however not had any ¿positive change¿ yet. Discussions about the possibility of creating a "lesion effect" with the lead were underway. The reporter stated that the implantable neurostimulator (ins) was going to be replaced. If additional information becomes available, a follow-up report will be submitted.

Manufacturer Narrative
Concomitant products: product id 37085-40, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3387-40, lot # 0208456401, implanted: (b)(6) 2014, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334699
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« Reply #118 on: January 10, 2015, 05:42:10 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient¿s ¿effect was stable¿ and their ¿programmer could work normally¿ following the replacement of their implantable neurostimulator (ins) on 2014-(b)(6). However, in 2014-(b)(6) the patient¿s programmer reportedly ¿couldn¿t work. ¿ furthermore, ¿the patient¿s limbs were trembling when the device was turned on. ¿ the patient¿s physician reportedly ¿judged the cause as lead disconnection. ¿ the patient¿s lead was replaced as a result. Following the lead replacement, ¿the patient¿s symptom got better and the programmer could work. ¿ it was noted the ¿patient didn¿t fall down¿ at that time. A supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant: product id 3389-40, lot# 0204990374, implanted: 2011-(b)(6), product type lead. (b)(4). Device evaluation: analysis of the lead found ¿all four conductors were broken 3. 3 cm from the proximal end of the lead. There was also breached esc (environmental stress cracking) 8. 8 and 9. 6 cm from the distal end of the lead. ¿ it was also noted that ¿all circuits were open¿ during functional testing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4325534
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« Reply #119 on: February 07, 2015, 07:12:30 AM »

Model Number 37602
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator; product id 3387s-40, lot# v802373, implanted: (b)(6) 2012, product type: lead; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387s-40, lot# v688050, implanted: (b)(6) 2011, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2011, product type: extension; product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. (b)(4).

Event Description
It was reported that the patient was experiencing a shocking/jolting sensation. Electrode and therapy impedance testing was done, no issues were found. There was intermittent tingling down the patient¿s right arm but it had not happened every day. The patient noticed an occasional shock sensation down the right arm. The patient was going to keep a log of events for the future. The patient had not had this sensation until after the battery change on (b)(6) 2014. It was unknown when the first time that this had occurred was. It was noted that this was an initial patient visit. The patient was alive with no injury. There was also a burning sensation down the right arm. No outcome or intervention was reported. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4402985
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« Reply #120 on: February 07, 2015, 09:06:41 AM »

Model Number 37602
Event Type Malfunction
Event Description
It was reported the patient had a shocking or jolting sensation. Since the patient¿s implantable neurostimulator (ins) was replaced in (b)(6) 2013 the patient had experienced significant shocks every time the ins was turned off with the patient programmer or during reprogramming. The healthcare professional (hcp) observed the shocks the day prior to this report when they were reprogramming the patient. The hcp stated the shocks were severe and lasted less than a couple seconds. The shocks were more severe when the ins was turned on. The patient felt the shocks on the left side of their face, arm, and leg. The hdp did not decrease stimulation before turn the ins off because it happened during reprogramming when they were changing the electrode configuration and the amplitude automatically dropped down to zero. The patient felt the shocks when the stimulation was at 0. 0v. The hcp stated that impedances may have been a little on the low side around 700-800 ohms, but nothing out of range. The patient was programmed at c+, 1- at 3. 5v, pulse width of 90, and a rate of 130 hz. The patient had previously been programmed at 4. 0v and a pulse width of 90. The ins was not programmed using interleaving and the ins was in voltage mode. Bipolar programming had not been tried. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id 3387s-40, lot# v311441, implanted: (b)(6) 2010, product type: lead; product id 37642, serial# (b)(4), implanted: (b)(6) 2011, product type: programmer, patient; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4393408
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« Reply #121 on: February 07, 2015, 11:09:57 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the patient was experiencing paresthesia and difficulty walking. The symptoms had occurred following implant. The patient had had problems with her arms since the device was implanted in (b)(6) 2012. Both arms had problems, arms were swollen at night time and some nights it was more than others. The patient kept twisting and turning at night because of her arms. After discussing with her healthcare professional the patient was told she was fine. The healthcare professional was seen a long time ago and had not been seen since. The patient had had a problem with their device since surgery and had gone through a 2nd surgery on one side, they had to open up the patient¿s head and do a wiring thing. The patient¿s wires were crooked and the patient had had surgery but they were still the same, the patient had not seen any change. The patient was unsure what was wrong with it because they were having problems with their head but now was having trouble with their neck. Every time the patient saw their healthcare professional they got numb on one side which had never happened before, they had had it before but it had gone away. The patient had had it in both legs prior to surgery. After her legs were fine and her arms, but she could not sleep at night. The patient had a funny feeling in her arms. The healthcare professional told the patient that it had nothing to do with surgery. It was noted that it might be an iron deficiency, but the patient wondered why their legs were not affected since they believed an iron deficiency would not impact just their arms. The patient¿s walking was very bad, she fell on her face when she walked and one time she fell and broke her hand but was told by her healthcare professional that this was not from parkinson¿s. The patient had an appointment scheduled for (b)(6) 2014. The patient had had a computerized tomography (ct) scan and found out there was a problem with the wiring in the brain that they had never told her about. The ct had been taken at the second surgery in (b)(6) 2012. The patient also had an appointment scheduled for (b)(6). No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted. Reference manufacturer¿s report number: 3004209178-2015-00143.

Manufacturer Narrative
Concomitant products: product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387-40, lot # va00fze, implanted: (b)(6) 2012, product type lead; product id 3387s-40, lot # va005vq, implanted: (b)(6) 2012, product type lead; product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387-40, lot # va00fze, implanted: (b)(6) 2012, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3387s-40, lot # va005vq, implanted: (b)(6) 2012, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4384377
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« Reply #122 on: February 07, 2015, 11:10:40 AM »

Model Number 37603
Event Date 12/10/2014
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # va08kln, implanted: (b)(6) 2013, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 3387s-40, lot # v233444, implanted: (b)(6) 2010, product type lead; product id 7438, serial # (b)(4), product type programmer, patient; product id 3387s-40, lot # v233444, implanted: (b)(6) 2010, product type lead. (b)(4).

Event Description
It was reported the patient had a loss of therapeutic effect. The patient had the implantable neurostimulator (ins) in their upper left chest for the right side of their body. For the last couple of days the patient¿s right arm had been shaking. The reporter stated the implant near the right collar bone did not work because it was in the wrong spot in the patient¿s brain so it did not work. It had not worked for a while so it was not on. The reporter stated they put it in the wrong spot in the brain. The ins was on and there was no known accident or incident related to this complaint. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, the event will be updated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377933
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« Reply #123 on: March 07, 2015, 04:12:08 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that a day after the patient¿s device was implanted, she used an electromagnetic therapy device close to her chest for wound treatment for 4 days. Two day¿s after she started using the device, she experienced a burning sensation in her abdomen. Approximately a month later, the patient had a tingling sensation in her arm, which got worse about a week later. Reprogramming was performed several times but the cause of the event was unknown. The patient was hospitalized for treatment. As of (b)(6) 2014, the patient still experienced tingling sensations and felt weak. It was unknown if the patient was receiving effective therapy. If additional information becomes available, a supplemental report will be submitted.

Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4553593
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« Reply #124 on: March 07, 2015, 04:49:39 AM »

Model Number NEU_INS_STIMULATOR
Event Type Death
Manufacturer Narrative
Date of death: please note the patient's date of death was unavailable at the time of report. The date reported reflects the date the attached literature article was published online. Other: psychosis. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead. (b)(4).

Event Description
Thavanesan, n. , gillies, m. , farrell, m. , green, a. L. , aziz, t. Deep brain stimulation in multiple system atrophy mimicking idiopathic parkinson's disease. Case reports in neurology. 2014;6(3):232-237. Doi: 10. 1159/000368571. Summary: deep brain stimulation (dbs) is approved for idiopathic parkinson¿s disease (ipd) but has a poor evidence base in parkinson-plus syndromes such as multiple system atrophy (msa). We describe the clinical and neuropathological findings in a man who was initially diagnosed with ipd, in whom dbs was unsuccessful, and in whom msa was unexpectedly diagnosed at a subsequent autopsy. This case report highlights that dbs is often unsuccessful in msa and also demonstrates that msa can masquerade as ipd, which may explain treatment failure in a small group of patients apparently suffering from parkinson¿s disease. Additionally, it also presents a case with an unusually long duration of disease prior to death, comparable only to a handful of other cases in the literature. Reported event: one (b)(6) male patient underwent 2-stage bilateral deep brain stimulation (dbs) implant for parkinson¿s disease in (b)(6) 2008. Stage 1 initially gave positive results barring an episode of confusion, hypotension and reduced glasgow coma scale (gcs) score attributed to overstimulation. Titration was effective, and the patient was switched from regular madopar to prn. Stage 2 was complication free aside from transient calibration paresthesia. Medications were stopped two days postoperatively with good gait, no tremor, no freezing and improved left arm mobility. A health care provider (hcp) and the patient specifically reported improvement in rigidity and gait. The patient was discharged three days later. The patient subsequently deteriorated after two weeks, returning to pre-operative medication doses, with his symptoms worse than preoperatively. The patient experienced confusion, short-term memory impairment and hypertonia in the left arm. Subsequent titration helped minimally. In the subsequent four years until time of death, the patient developed episodes of psychosis, dopamine dysregulation syndrome, iga nephropathy, chronic renal failure and ultimately terminal clostridium difficile colitis. Neuropathological examination, performed six years after surgery during the patient¿s autopsy, confirmed the placement of dbs electrodes in the subthalamic nucleus (stn). The neuropathological findings were those of multiple system atrophy (msa). The pathological diagnosis was based on extensive striatal and subcortical white matter accumulation of ¿-synuclein coupled with profound depletion of the neurons from the striatum and substantia nigra with atrophy and gliosis. Oligodendroglial ¿-synuclein inclusions were also very extensive in cerebral and cerebellar white matter, and the middle cerebellar peduncle also showed prominent ¿-synuclein-positive glial inclusions indicating elements of both a striatonigral and olivopontocerebellar pattern of distribution. Noteworthy was the finding of prominent ¿-synuclein-positive glial inclusions adjacent to the dbs insertion site in the stn. It was noted that incorrect preoperative idiopathic parkinson¿s disease diagnose showed positive initial response to surgery followed by rapid decline secondary to progression of msa and subsequent death. The source literature did not include any specific device information. Further information has been requested; a supplemental report will be submitted if additional information is received.

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« Reply #125 on: April 19, 2015, 02:28:11 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3389s-40, lot# va090aq, implanted: (b)(6) 2013, product type: lead; product id 3389s-40, lot# va08ytx, implanted: (b)(6) 2013, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension; product id 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).

Event Description
It was reported that there was a left lead fracture adjacent to the stimloc. The action required as a result of the event was a replacement. Diagnostic testing and troubleshooting included impedance testing and x-rays. The issue was not resolved and the cause was not determined. Patient symptoms associated with the event were increasing dysphagia and rigidity in the left upper extremity. The location of the symptom was the lead location. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4565375
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« Reply #126 on: May 09, 2015, 02:42:05 AM »

Model Number 37601
Event Date 10/01/2014
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3387, lot# unknown, product type: lead; product id 3387, lot# unknown, product type: lead; product id neu_unknown_ext, serial# unknown, product type: extension; product id neu_unknown_ext, serial# unknown, product type: extension. (b)(4).

Event Description
It was reported that the patient experienced myoclonic jerks of arms and legs. Corrective actions included medication added, discontinued or dose changed. Depakote was started after lab work was reviewed on (b)(6) 2014. The event was not resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4662492
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« Reply #127 on: June 08, 2015, 05:59:15 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported the patient had chest pain, a loss of effect, and a lack of symptom control since the replacement of their implantable neurostimulators (ins). The patient had been having slurred speech and issues with controlling their tongue. On the day prior to this report, the patient had bit their tongue bad, which had made their speech even worse. The patient¿s jaw was tight and they almost broke a tooth. Every time the patient had their ins replaced, it took them three months to get the ins properly adjusted and for them to receive any benefit. The patient also had an increase in rigidity and dystonia in their neck and extremities with their left being worse than the right. The patient met with their healthcare professional (hcp) a day prior to this report because their pain was so bad they thought they were having a heart attack. The pain was located in the patient¿s chest near the ins and in their armpits. An x-ray was done and the patient was going to follow up with their cardiologist. The patient was evaluated by their cardiologist and cardiac etiology was ruled out. Impedances were checked and one of the contacts was not being used. Impedances of electrode zero were measured to be greater than 40,000 ohms on the left side. The left ins was programmed to 2-, 3+ at 4. 7v, 90 usec, and 145 hz. Impedances of electrode three were measured to be greater than 40 ,000 ohms on the right side. The right ins was programmed to 1+, 2- at 4. 2v, 90 usec, and 145 hz. Therapy impedances were measured to be within normal limits on both sides. The patient¿s hcp planned on reprogramming the ins to get efficacy. The cause of the event was not determined. A troubleshooting revision had been scheduled for (b)(6) 2015 due to the high impedances. During the revision, the hcp opened the right incision and noticed the bottom two screws on the ins were not tightened. The hcp loosened all four screws, dried off the extension, and retightened everything. The right side bottom connector for the ins and extension still seemed not tight and there was a small gap, but everything was tightened down. Impedances were then tested and all impedances were within normal limits. The same issue occurred when the left side incision was opened. After the revision, all impedances were within normal limits on both sides and no further troubleshooting was done. Refer to manufacturer report #3004209178-2015-09832.

Manufacturer Narrative
Concomitant products: product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v475868, implanted: (b)(6) 2010, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2015, product type implantable neurostimulator; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v443426, implanted: (b)(6) 2010, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4802318
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« Reply #128 on: June 08, 2015, 06:00:13 AM »

Model Number 37601
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # va0apc0, implanted: (b)(6) 2013, product type lead; product id 3389s-40, lot # va0apc0, implanted: (b)(6) 2013, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension. (b)(4).

Event Description
It was reported the patient had a shocking or jolting sensation when they turned their head a certain way or sometimes when they turned their head left. The patient felt a shock like sensation in their chest and arm area that only occurred when the implantable neurostimulator (ins) was on. The patient¿s grandson had stepped on the ins at some point and the patient thought the issue started soon after. The patient had thought they had neck issues that created the sensation. When the patient met with their healthcare professional (hcp), they were more convinced the issue was related to their ins. Impedances had been checked and some electrodes were out of range. The following high impedances were measured on the right side at 3v: c-8 = 2521, c-9 = 2293, 8-9 = 4381, 8-11 = 4647 and 9-11 = 4194 ohms. The ins was turned off for three hours and the patient did not feel the sensation. X-rays were normal and everything else read normal. The patient had no obvious loss of benefit, but they were not doing as well as they once were. The patient was under a tremendous amount of stress and they had stopped exercising. The patient did have a reduction in symptoms control, but they also had a urinary tract infection that had caused some decline in the past. The cause of the event had not been determined and the patient had not recovered. The symptoms/issue were ongoing and the hcp was trying to figure out the problem. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4801009
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« Reply #129 on: June 08, 2015, 07:06:46 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the essential tremor patient experienced ¿shocking sensations and paresthesias¿ in his left arm, torso, and leg with the sensations ¿not limited to a specific location. ¿ the patient reportedly ¿could induce the sensation when pressing onto the implantable neurostimulator (ins),¿ however sometimes the shocking sensations would also occur ¿without any external influence. ¿ the patient additionally experienced ¿intermittent stimulation,¿ whereby the patient¿s tremors ¿reoccurred regularly, as if the ins was turned off. ¿ it was stated the patient experienced ¿less than 50% therapy relief¿ on his left side. These tremors would occur ¿sometimes for several hours. ¿ the tremor would then ¿disappear on its own later, as if the stimulation was turned back on. ¿ it was noted the patient lost his paresthesia and therapy within 24 hours of having his ins interrogated with a physician programmer at the time of report. Impedance testing was performed and found ¿fine¿ impedance values. X-ray imaging ¿didn¿t show any anomalies in the extensions/leads. ¿ the patient¿s stimulation was reprogrammed to a bipolar stimulation setting in an attempt at troubleshooting the situation; however, it was noted that ¿even with the bipolar stimulation there was a shocking sensation when touching the ins. ¿ the patient¿s ¿stimulation was still intermittent¿ and a revision surgery was planned for the patient as of 16 days after initial report. Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4743368
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« Reply #130 on: July 15, 2015, 11:16:31 PM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 7482a51, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# va00dcw, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
It was reported that the patient¿s lead extension started to slide down his skull soon after implant. Eventually it slid off of his skull. Skin erosion was also reported. This was followed by decreased benefit. It was also reported that when the patient was on vacation he felt his device turning on and off. He felt tingling in his arm and leg like when the device was turned on/ off. The patient¿s implant was revised and replaced in 2013. The extension was removed but the lead remained implanted. No outcomes were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4813073
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« Reply #131 on: July 15, 2015, 11:17:44 PM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the essential tremor patient experienced reduced therapy post-operatively with ¿less than 50% therapy relief. ¿ the patient also experienced a shocking sensation down their arm and spasms. These issues were reported to have occurred after the patient had a large fall. Prior to the fall it was noted he patient ¿had good tremor suppression. ¿ a revision procedure was performed whereby the patient¿s scalp was opened and it was observed the lead was ¿visibly fractured. ¿ the lead was ¿fractured slightly distal from where bone cement secured the lead. ¿ it was noted the ¿damage was detected capping the lead. ¿ impedance testing was performed with an external neurostimulator (ens) at that time and found that contact 0 was ¿open. ¿ as a result, the bone cement present with the lead was drilled and the lead was removed and replaced with a new lead. The patient was to have their therapy switched on 17 days aft er initial report. Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant medical products: product id 3387-28, lot# unknown, implanted: (b)(6) 2002, explanted: (b)(6) 2015, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4841423
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« Reply #132 on: July 15, 2015, 11:30:01 PM »

Model Number 37601
Event Type Injury
Event Description
It was reported that stimulation was turning off on its own and the patient did not know what was causing it. The patient was not feeling confident with the patient programmer and inquired if he was reading the programmer right. The patient had had programming done in (b)(6) 2015 and programming was not helping with symptoms. The patient had called their healthcare professional about this. On (b)(6) 2015, the implantable neurostimulator (ins) was turned off and he was seeing stimulation at 2. 5v on one side and 3. 5v on the other side and it said off on the top. The ins was turned back on. The ins had turned off on saturday prior to the date of this report and it was a normal day. It was off on monday and the left arm was paralyzed, he could not lift his arm or move his elbow over his shoulder. The patient takes 9 doses of sinemet and had stated he had ¿worst days and bad days and the bad days are not good. ¿ the patient was in a wheel chair. Further follow-up is being conducted. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v939343, implanted: (b)(6) 2012, product type lead; product id 3389s-40, lot # v939343, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4865984
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« Reply #133 on: August 08, 2015, 09:38:05 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that there was a tingling following a battery replacement. The patient started having numbness on one side of his face including the lips 2 weeks prior to the report. The symptoms were worse in the morning but would subside if the patient pressed on the implant with his hand. Imaging was performed and impedances were checked and nothing abnormal was found. Additional information received one month later reported there was a shocking sensation at the implantable neurostimulator (ins) pocket site and a stroke symptom at the right arm. It was a gradual change in therapy/symptoms. Towards the end of the device in (b)(6) 2015, the patient felt stroke symptoms at the right side of the arm. They turned the stimulation off. When the patient received their last implant in (b)(6) 2014, that is when he noticed a strange feeling initially (not shocking) and he had reprogramming sessions; however, it kept getting worse. When the patient would turn the stimulation on in the mornings, his lips would go numb for about a minute and then it would subside. He had the same experience with the first implant. The month prior to report whenever he reached he felt shocking on the whole right side of his body. There were intermittent impedances. Impedances would change with positional changes. The patient had a replacement done in (b)(6) 2015 for normal battery replacement. When they replaced the ins and extension, they both tested well. The new ins was working with no issues. The ins replacement resolved the shocking issue. No trauma or falls were reported and there were no unrelated medical procedures. The patient recovered completely.

Manufacturer Narrative
Concomitant products: product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 3387s-40, lot# v140982, implanted: (b)(6) 2008, product type: lead. Product id: 3387s-40, lot# v134483, implanted: (b)(6) 2008, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4919122
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« Reply #134 on: August 08, 2015, 09:39:07 AM »

Model Number 37601
Event Date 06/12/2015
Event Type Malfunction
Event Description
Additional information reported that the patient did not have concerns with their device or therapy now. The patient received assistance from their healthcare professional or manufacturer representative on 2015 (b)(6) and their concerns were resolved.
Manufacturer Narrative
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0gvdy, implanted:(b)(6) 2014, product type: lead. Product id: 3387s-40, lot# va0gvdy, implanted: (b)(6) 2014, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708695, serial# (b)(4), implanted:(b)(6) 2014, product type: extension. Product id: 3708695, serial# (b)(4), implanted:(b)(6) 2014, product type: extension. (b)(4).

Event Description
It was reported the night prior to this report, the patient started feeling a vibration in their right arm at the inside of their elbow every ten seconds. The patient¿s pain level was a three on a scale of 1-10. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4882932
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« Reply #135 on: August 08, 2015, 09:39:51 AM »

Model Number 37612
Event Date 06/10/2015
Event Type Malfunction
Event Description
It was reported the patient programmer was not powering on and the recharger displayed a ¿call your doctor¿ icon and a 375 antenna failure error code. New batteries were tried in the programmer, but the issue was not resolved. The new batteries were brand new and the patient confirmed they were positioned correctly. The patient was not able to recharge the implantable neurostimulator (ins). When the patient tried to recharge the ins, they saw the ¿call your doctor¿ icon. Normally, the patient recharged just about every day. The patient was having a return of symptoms and their arm was shaking terribly since the day prior to this report. Upon device return, analysis of the patient programmer found the antenna jack was resoldered as a preventative measure. Upon device return, analysis of the recharger found the recharge antenna failed. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v181305, implanted: (b)(6) 2009, product type: lead. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: neu_unknown, serial# unknown, product type: unknown. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4882203
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« Reply #136 on: August 08, 2015, 09:40:41 AM »

Model Number 37602
Event Type Malfunction
Event Description
It was reported the patient had a shocking sensation and shooting painful stimulation in their chest, arm, and hand. The patient was fine until about two weeks prior to this report. Over the weekend prior to this report, the patient went to the emergency room due to pain in their chest and a change in their issue. Stimulation was turned off in the emergency room and the pain went away. During the visit, an elective replacement indicator (eri) message was displayed. The implantable neurostimulator (ins) was at 2. 56v. A manufacturing representative met with the patient on the day of this report and the ins was turned off. Impedances were measured and there was nothing out of the ordinary. During the impedance measurement, the patient felt shooting pain. The ins was programmed to 1+, 2- at 4v, 90 usec, and 185 hz. No recent car accidents or falls were noted. The patient did not experience symptoms when the ins was turned off. The manufacturing representative attempted to turn stimulation on and they got to 1. 4v when the patient felt stimulation in their arm and hand. The patient had an appointment scheduled with a surgeon on (b)(6) 2015 to discuss replacement of the ins since the ins was at eri. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent. Refer to manufacturer report #3004209178-2015-13638.

Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 37642, serial# (b)(4), implanted: (b)(6) 2012, product type: programmer, patient; product id 3387s-40, lot# va02nm4, implanted: (b)(6) 2012, product type: lead; product id 7482a95, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387-40, lot# j0401949v, implanted: (b)(6) 2004, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension; product id 7438, serial# (b)(4), implanted: (b)(6) 2004, product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4924887
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« Reply #137 on: September 07, 2015, 07:36:05 AM »

Model Number 37612
Device Problems Failure to deliver energy; Communication or transmission issue
Event Type Malfunction
Manufacturer Narrative
Product id 37651, serial# (b)(4); product type recharger product id 3387-40, lot# v000198, implanted: 2005 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2004 (b)(6); product type extension product id 37651, serial# (b)(4); product type recharger. (b)(4).

Event Description
A consumer reported that they did not think their recharger was working to charge the implantable neurostimulator (ins) because their tremor came back suddenly and was very bad. The patient had poor telemetry or no telemetry when recharging and they were having difficulty recharging. The patient was told to charge for 20 minutes a day and they had been doing that. After positioning the antenna over the ins, the patient was able to get 6-8 coupling bars and the ins was charging up to about a quarter full. The recharger was working normally and the patient was able to charge successfully. The ins was confirmed to be off at the time of this report, but the patient was able to turn the ins back on. Initially the patient felt an uncomfortable tingling sensation down their arm, but the sensation dissipated during the call. The patient's tremor had also gone away. The patient's indication for use is parkinson's dual and movement disorders. Troubleshooting had resolved the issue and the patient was going to follow up with their health care provider if they continued to have symptoms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5031373
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« Reply #138 on: September 07, 2015, 07:36:49 AM »

Model Number 37602
Event Date 07/11/2015
Event Type Injury
Event Description
It was reported the patient was admitted to the emergency room due to a loss of therapeutic benefit. The patient first noticed the loss of deep brain stimulation (dbs) benefit last night and today, the patient¿s arms and legs were moving wildly. The patient was brought to the emergency room by ambulance. Both of the patient¿s implantable neurostimulators (ins) were checked using the patient programmer and they were both on and at 3. 4v. Impedances were not checked. The patient indicated that prior to being taken to the emergency room, a nurse at their assisted living center may have made changes to their therapy, but they did not know what changes were made. The last reprogramming session was 3-4 months ago. The patient had no falls or trauma and had not been had any recent medical tests or environmental exposure. The reporter wanted to know if a manufacturing representative could check the inss. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3389-40, lot# v000631, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 37642, serial# (b)(4), implanted: (b)(6) 2012, product type: programmer, patient. Product id: 3389-40, lot# j0537580v, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4961817
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« Reply #139 on: September 07, 2015, 07:37:37 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3387s-40, lot# va09evkv02, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va09evkv02, implanted: 2014 (b)(6). Product type lead. (b)(4).

Event Description
The health care professional (hcp) reported via a manufacturer representative (rep) that there was troubleshooting needed for an imp edance issue. The patient related to the event had severe intractable bilateral essential tremor of the upper extremities, head, trunk, and voice tremor. The indication for use was essential tremor. The patient had a bilateral ventrointermediate nucleus deep brain stimulation (dbs) implanted in (b)(6) 2014. The consumer reported improvement of her symptoms since the dbs had been instituted, however, she did recall that ever since the very first programming session she was noted to have a high sensitivity and low side effect threshold. Over the last month, the patient had worsening head tremor and also had an electrical shock painful sensation when she tapped her scalp over the parietal connectors on the left side. This seemed to indicate a break in the insulation that was experienced when the lead was stressed. They would probably need to replace this lead to resolve the issue. X-rays were done to see if there was a disconnection or obvious circuitry probable over the left connector. Even if the x-rays were normal, they may benefit to revising the connection leads to insulate them better to see if this can avoid the electrical phenomenon. This would not be like ly to effect her tremor control or side effect stimulation thresholds. There was a skull x-ray showing the area that the surgeon was concerned about. It was on the left side, which matched where the patient felt the shocks, but it was a more frontal location than the surgeon was expecting. Coiling could be seen very faintly if zoomed in on the lead pictures. When they ran impedances initially on the left at the default 0. 7 volts, they had out of range impedances. Then they re-ran the impedances at 1. 5 volts and the impedances were in range. This made the hcp think that there was either an intermittent issue or the impedances were greater than 10000 ohms. Impedance testing did not reveal any major abnormalities. There were two contacts with a high impedance on the left that returned to normal impedance when tested at a 1. 5 volt testing threshold, which would indicate a normal impedance profile. The patient's scalp incision sites were clean, dry, and intact. She appeared to have a duel extension lead tunnel to the left. There was an implantable pulse generator (ipg) in the left intraclavicular position with a small amount of swelling with no erythema or tenderness. However, she had tenderness and a pulse-like shock sensation when tapped over the connector sites. This sensation disappeared when the device was turned off and it was present when the right or the left side was activated. The right side case was positive, 9 negative, pulse width 60, frequency of 150, amplitude of 1. 7 volts. The left side case was positive, 3 negative, pulse width 60, frequency of 150, amplitude of 1. 7 volts. There was some testing of the 0, 1, and 2 contacts on the left side, all of which produced unacceptable paresthesia and/or motor drive thresholds. It was experimented with a pulse width increased to 90 but were only able to achieve 1. 5 volts at this pulse width without developing unacceptable motor drive side effects. This side was returned to pulse width of 60, amplitude to 1. 7 volts, and monopolar stimulation to the number 9 electrode. There were two problems being experienced by the patient. She had very low side effect thresholds with stimulation. This was not a new phenomenon and was present since the initial program ing. It was possible that she was developing some tolerance and tremor breakthrough, and since higher voltages are being required she was unable to tolerate these due to the low thresholds. This was most likely due to initial lead placement and cannot be easily co rrected. The second problems was a shock-like painful sensation. After follow-up with the rep, the patient had worsening of tremor and would have a revision. The date of the revision was not yet scheduled. No outcome or intervention was reported regarding this event. If additional information is received, a follow-up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4976727
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« Reply #140 on: September 07, 2015, 07:38:52 AM »

Model Number 37603
Device Problems Failure to interrogate; Device displays error message; Communication or transmission issue; Electromagnetic compatibility issue
Event Type Injury

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_ext, product type: extension. Product id: 3389, product type: lead. (b)(4).

Event Description
The patient reported that symptom returned. The patient was implanted for essential tremors on the right side. The patient had good reduction in symptoms right after first programming on (b)(6), then 24 hours later the patient started having problems. It was also noted that the programming has gone well and the patient received good benefit. The programmer reads the setting was being in service, however, tremor has returned and no relief of symptoms. The patient was driving and then his tremors returned. When the patient returned home, he turned the device off then turned device on, no changes. "they have changes setting not change in symptoms". It was confirmed that the patient has not fallen or accidentally hit his device, no trauma. The patient did contact his clinic. Two days later the patient was seen at his doctor's office and the ins was checked with the clinician programmer. The ins was working as planned. The patient came back for reprogramming. Less than a week later the patient's health care provider (hcp) reported a loss of therapy. It has happened twice now, where all of a sudden, the patient's tremor was no longer controlled by the ins. The patient went to his doctor for a final adjustment. The device was working for only 24 hours. The programmer indicated the ins was on and working. The patient has an insulin pump that he clips to his shirt collar on the opposite side of his chest from the implantable neurostimulator (ins). When the clip is close to the ins, the patient programmer (pp) will not read the ins nor will the pp work. The patient knows the device is on as he feels tingling in his right arm when the stimulation is on. The patient was not feeling any tingling in his hand when device comes on like he used to. When the insulin pump was clipped to the patient's belt, it does not affect the ins and the pp from communicating. The hcp was told that the ins was on but the patient verified that he has been playing with the settings via the pp. It was further stated that the tremor came back, even with the program running but the patient had shut the system off, as nothing they did seemed to work. The hcp turned it on and the patient felt the program start once again. The patient drove all the way home and it happened again; program on and tremor back. The system was interrogated; no codes and no impedance issue. Emi compatibility guidelines were requested. The following is the patient's diary information for (b)(6) 2015: 5:40 pm - on at 2. 00 then up to 2. 80 -nothing then up to 3. 40 - big buzz up arm then down to 2. 8 - cue test worked 5:45 - down to 2. 00 -seems to work but not with cue then up to 2. 60 - buzz - 90% with cue then up to 2. 80 - buzz - 90% with cue 5:50 - down to 2. 00 - turned off and out of regulation error message 00r with phone to doctor shown on page 106 appeared 7:05 - turned on at 2. 00 - buzz then up to 2. 80 - felt no difference - no help with cue then down to 2. 00 - seemed to be working then up to 3. 40 - buzz then down to 2. 80 - no help with cue then down to 2. 00 - not sure its working 8:30 - using my left hand, i pulled my head toward my left shoulder and felt a buzz in my right hand 9:55 -changed from 2. 00 to 2. 80 - felt a buzz and worked with cue back to 2. 00 from 2. 80 - hand writing feels better turned off note: between 8:30 and 9:55 i sometimes got a buzz when yawning. Cue was referring to the patient's pool cue when he checks to see if he can play "snooker. " the next day the hcp reported again a change in the patient's therapy. The change was considered sudden but also reported as gradual. The patient continues to have intermittent therapy/tremor, tremor comes and goes; and intermittent return of symptoms and tingling in right hand. The hcp has tried different scenarios and was not able to replicate the problem the patient had. The device was off when the patient arrived at the clinic. The hcp turned the device on with the remote and the ins was interrogated, no codes were present. The patient felt a sensation in his right arm, and noticed a reduction of tremor. The patient's wife is confident with the navigation of the pp. The hcp asked the patient's wife to leave the pp on over the next several weeks, and just push the orange button when they need to check the status of the program, or to turn the device off at night; they can push the off switch. Impedances were tested at 1. 5v and c-0 were >10k; when turning head to the right contacts 1-2 were 195ohms and when turning to left no problem. Telemetry strips showed c<(>&<)>0 were >20,000 ohms and 1<(>&<)>2 were 196 ohms. Change in therapy was related to positional movement. The patient sometimes feels tingling in his right hand. The hcp will try palpating the ins and extension connection to determine location of the problem. After doing some further diagnostic testing with the patient, putting strain on the lead/extension connection, a short circuit with 1 <(>&<)>2 and open with c<(>&<)>0. The implanting hcp will be taking the patient to the or and open up the lead/extension site to see if fluid got in the connection. The hcp will most likely replace the extension. Further information was requested but the hcp returns to the office on 08/05/2015. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4988000
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dennis100
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« Reply #141 on: September 07, 2015, 07:39:40 AM »

Model Number 37601
Device Problem High impedance
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 748251, serial# (b)(4), product type: extension. Product id 3708660, serial# (b)(4), product type: extension. Product id 3708660, serial# (b)(4), product type: extension. Product id 748251, serial# (b)(4), product type: extension. Product id 64002, product type: adapter. Product id 3550-29, product type: accessory. (b)(4). Device evaluation: analysis of extension (b)(4) found ¿the extension was fine electrically but conductor #3 was exposed at a breached depression on the outer insulation at 23. 2 cm from the distal end. ¿ analysis of extension (b)(4) found ¿the extension was fine electrically but conductor #3 was exposed at a breached depression on the outer insulation at 47. 0 cm from the distal end. ¿ analysis of extensions (b)(4) and (b)(4) and the pocket adapter found no anomalies.

Event Description
The patient's physician reported the patient "felt electrifying pain near the implantable neurostimulator (ins) and toward poor in the right side. " it was noted this had occurred following an ins replacement with an ins and pocket adapter, though initially following the replacement "everything was ok. " the patient reported they felt increasing electrical pain in the area of the ins with the pain radiating into their arm following the replacement. Initial impedance testing performed after the implant of the ins and adapter found "normal" impedances. Impedance testing performed at the time of report found the impedances were "too high" to be measured. The patient's physician performed troubleshooting through a revision procedure as a result. First, the physician changed the patient's pocket adapter, with "no improvement of the impedances. " the physician then changed the patient's extensions ((b)(4) and (b)(4)), "but with the new extensions the impedances were not measureable, so the physician changed the new extensions ((b)(4) and (b)(4)) again with two new extensions. " the impedances for contacts 0 and 8 reportedly remained not measurable at that time. It was reported the second pair of replacement extensions remained implanted at the time of report and the patient was "well" and "got an effective therapy" from their device. The physician was to be followed-up with a week after initial report. A supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5004520
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dennis100
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« Reply #142 on: September 07, 2015, 07:40:24 AM »

Model Number 37603
Event Date 07/29/2015
Event Type Injury
Event Description
The healthcare professional reported that patient experienced a sudden upper extremity weakness bilaterally and was being admitted to the hospital. This event occurred during product use and the indication for use was movement disorders. No outcome regarding this event was reported. Further follow- up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent. Please see manufacturer report #3004209178-2015-16134 for information on the patient's concomitant system.

Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3387s-40, lot# va05cbr, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va04smb, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5008038
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dennis100
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« Reply #143 on: September 19, 2015, 02:42:19 AM »

Model Number 7428
Event Date 08/11/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
The consumer via a manufacturer representative reported that the patient was implanted on (b)(6) 2013 due to parkinson's disease. On (b)(6) 2015, the patient's limbs felt rigid and it was difficult for them to walk. The patient suspected that the implantable neurostimulator (ins) was shut down. The patient requested a reprogramming on (b)(6) 2015. No troubleshooting was done and the event cause was not determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5043176
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dennis100
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« Reply #144 on: September 19, 2015, 02:43:09 AM »

Model Number 37601
Event Date 07/01/2015
Event Type Malfunction
Event Description
The friends/family of the patient reported that the patient had felt shocking/jolting in the arm, left shoulder and head since implant ((b)(6) 2015). The indications for use (ifus) were essential tremor and movement disorders. Further follow-up is being conducted to obtain information. If additional information is received, a follow-up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 64002, lot# n434139 , implanted: (b)(6) 2015, product type: adapter. Product id: 3387s-40, lot# v120700, implanted: (b)(6) 2008, product type: lead. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5027535
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