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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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