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Author Topic: Deep brain stimulator - Shocking  (Read 82273 times)
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dennis100
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« on: November 05, 2013, 11:57:23 PM »

Model Number IPGNEURO
Device Problems Connection issue; Device operates differently than expected
Event Date 03/17/2011
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).
 
Event Description

Rec'd information the pt was in the intensive care unit at the hospital on a ventilator. The physician reports the pt is "jolting" as if being shocked by a defibrillator. The manufacturer's rep will go to the hospital and turn off the device. Additional information has been requested and if rec'd, a f/u report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2061837
« Last Edit: July 16, 2015, 12:09:15 AM by dennis100 » Logged
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« Reply #1 on: November 05, 2013, 11:57:44 PM »

Event Type  Malfunction  
Event Description

It was reported that the patient experienced a shocking sensation when laying on the side where the implantable neurostimulator was located. The patient was involved in a car accident in (b)(6) 2011 and began experiencing the shocking sensation following the accident. X-rays did not reveal anything remarkable and could not confirm breakage. There was no change in therapy and impedances were within normal limits. The physician offered to perform an investigational revision. The patient outcome was not known.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2507562


« Last Edit: February 03, 2014, 01:17:01 AM by dennis100 » Logged
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« Reply #2 on: November 05, 2013, 11:58:07 PM »

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, 01:18:10 AM by dennis100 » Logged
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« Reply #3 on: November 05, 2013, 11:59:00 PM »

Model Number IPGNEURO
Device Problem Inappropriate shock
Event Date 05/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

The patient no longer had effective stimulation. The patient experienced a shock. Leak breakage was suspected. The lead was replaced. There was reported to be no patient injury. The patient was "fine" following the lead replacement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1723620

« Last Edit: February 03, 2014, 01:18:35 AM by dennis100 » Logged
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« Reply #4 on: November 05, 2013, 11:59:22 PM »

Model Number IPGNEURO
Device Problem Inappropriate shock
Event Date 08/01/2010
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the pt experienced a shocking/jolting sensation. Additional information was requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1825513
« Last Edit: February 03, 2014, 01:18:50 AM by dennis100 » Logged
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« Reply #5 on: November 05, 2013, 11:59:49 PM »

Model Number IPGNEURO
Device Problem Inappropriate shock
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).
 
Event Description

The pt experienced a fairly severe shocking sensation when putting the time right on the clock and when checking impedances and therapy. Impedance measurements were good, reporting for problems. It was noted that he has fallen a number of times and probably hit his abdomen and not his head. He had an x-ray for pain over his ribs on the right side. The pt came in for an urgent care f/u. He had two swallow studies which showed he was aspirating. He was reprogrammed reducing the rate from 140 to 130 and was able to talk easier. He will have a f/u swallow study. The device was giving him therapy. He will be seen in two months or before hand if he has more problems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1913531
« Last Edit: February 03, 2014, 01:19:16 AM by dennis100 » Logged
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« Reply #6 on: November 09, 2013, 05:39:44 AM »

Device Problem Device remains activated
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative

See scanned pages.
 
Event Description

Literature: tringali g, broggi g. Reversible neurological symptoms caused by diathermy in a pt with deep brain stimulators: case report - commentary on article. Neurosurgery. 2008;62(1):e256. Reportable event: the authors of the article commentary discussed a male pt, implanted for chronic cluster headache who reported an electric shock from a home accident with sudden loss of consciousness. He had been immediately referred to their department. At the time of hospitalization, he had already recovered consciousness. An mri scan obtained after approx. 1 hour did not demonstrate any injures such as that repeated at 1 month. His immediate post implant mri scan did not show any signal alteration, so they supposed that edema can play a pivotal role in the spreading of the current.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161222

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« Reply #7 on: November 10, 2013, 03:55:30 AM »

Device Problems Device remains implanted; Inappropriate shock
Event Date 01/01/2009
Event Type  Malfunction 
Manufacturer Narrative

 
Event Description

It was reported that patient experienced a loss of therapeutic effect. The patient felt "electrocuted" by the system. It was reported that the patient also experienced a return of disease, falling, tremors, and the inability to get out of bed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1428933

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« Reply #8 on: November 10, 2013, 05:12:10 AM »

Model Number IPGNEURO
Device Problem Inappropriate shock
Event Date 02/11/2009
Event Type  Malfunction 
Manufacturer Narrative

 
Event Description

Approx one week after implant, when the pt programmer was placed over the implantable neurostimulator (ins) and "review" was pressed, the pt experienced a surging sensation. The pt also experienced a shock and tingling of the tongue. It was unk whether appropriate programming or softstart were present. The physician was certain that the pressed review and not the on button. 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=1386124


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« Reply #9 on: December 06, 2013, 01:19:10 PM »

Model Number 7426
Event Date 10/25/2013
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v606250, implanted: (b)(6) 2011, product type lead; product id 7426, serial # (b)(4), implanted: (b)(6) 2011, product type implantable neurostimulator; product id 3387s-40, lot # v606250, implanted: (b)(6) 2011, product type lead; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2011, product type extension; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2011, product type extension; product id 3387s-40, lot # v606250, implanted: (b)(6) 2011, product type lead. (b)(4).

 
Event Description
It was reported that a loss of efficacy occurred, the patient had a return of tremor. This occurred after the patient fell (date unknown). There were high impedances >2000 ohms and the return of symptoms affecting the left side, but the reporter was "unsure if it was left device side, or therapy side at this point. " it was also reported that the fall had occurred four days prior to the report when the patient hit left side of the head (the tremor was on the right side of the body). The patient had swelling on that part of head at the time of the report. When the voltage was increased from 3. 7 v to 4. 7 v, the patient did get "jaw tightening and hurt. " it was also noted, when the ins (implantable neurostimulator) was turned off, her tremor was not as bad as with stimulation on. It was stated that there were high impedances >2000 ohms on all of the unipolar pairs. It was also stated that the current except on the contacts c<(>&<)>2 was less than 7ua, c<(>&<)>2 was exactly at 7ua. When the impedance check was rerun while laying down at 3. 0 v, the patient was hurting in the pocket area. There was also burning / shocking and the patient started to cry. This was the first time the patient felt this while checking impedances. The patient was laying down during this time. It wasn't possible to palpate due to swelling. At the time of the report, the longevity parameter was 2. 2 years to eos (end of service). A "buzzing" or "zap" (like hitting a funny bone) when laying down had occurred a few times, and this had only happened for the past few months prior to the report. It was determined this was caused by the removal of telemetry head during the impedance test. 185 hz and 90 microseconds of pulse width were patient's normal settings. It was also reported that there was going to be a revision and the reporter was trying to determine if the ins replacement was needed, as well. The ins was reading 3. 71 v on the day of the report. Three days later it was reported that this patient would have to be taken to surgery to determine if lead or extension was broken. This hadn¿t been scheduled yet. The patient had an x-ray taken and this didn¿t show any visible fracture in lead/extension. The patient wasn¿t receiving therapeutic benefit at the time of the report.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3476202
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« Reply #10 on: December 06, 2013, 01:19:51 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the ¿wire was damaged, almost a short giving [the patient] a bit of a shock. ¿ the patient stated the device lasted only lasted 10-11 months and was replaced. The device was replaced due to issues with the wire and battery depletion.

 
Manufacturer Narrative
Concomitant medical products: product id 3387-40, lot# j0204763v, implanted: (b)(6) 2002, explanted: (b)(6) 2009, product type: lead; product id 3387-40, serial# (b)(4), implanted: (b)(6) 2002, explanted: (b)(6) 2009, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3486280
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« Reply #11 on: December 06, 2013, 01:20:20 PM »

Model Number 7426
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was initially reported that the patient had experienced a shocking or jolting sensation. She had a ct scan in 2005, and during the procedure she could feel electricity going through her body. It was also stated the technician performing the ct scan could see "arching" on the stimulators while he was doing the scan. The patient was terrified. It was stated the technician never stopped the ct scan. The patient went into hcp (health care professional) office for adjustments but they didn't seem to last. It was further reported that the patient had the ct scan in (b)(6) 2006. She had many ct scans and that had never happened to her before. Since ct scan, the patient had to frequently go in for adjustments and those didn't last. The patient and the physician decided to keep the device off. She had the device turned off from physician since (b)(6) 2007. It was later reported that she also had an mri (although the information reasonably suggested that the reporter meant to mention the ct scan, instead) and somehow the electricity went through the lead and she had a "mini-thalamotomy" which caused additional pain for 2 years. The stimulation was permanently turned off. Additional information has been requested but was not available as of the date of this report. When received, a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3446377
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« Reply #12 on: December 07, 2013, 06:12:25 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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« Reply #13 on: December 07, 2013, 06:13:46 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that there was a shocking/jolting sensation. It was stated that the implantable neurostimulator (ins) was explanted and replaced. It was noted that impedance testing, x-rays, and reprogramming were performed. The patient reportedly had pocket ¿zapping¿ and tightness in the neck along the extensions so the extensions were explanted and removed. It was noted that the patient experienced pain at the device pocket. The pocket zapping was described as a ¿bee sting¿ sensation in the pocket. It was stated that the patient was alive with no injury. It was later reported that the patient initially had patient discomfort from the pocket ¿zapping¿ and tightness in neck. It was noted that no short circuits had been detected and the patient recovered without sequela.

 
Manufacturer Narrative
Product id 3708660, serial# (b)(4), implanted: 2012 (b)(6), explanted: 2013 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2012 (b)(6), explanted: 2013 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40 lot# va01uj1; product type lead product id 3387s-40 lot# va03bqa; product type lead. (b)(4). Device has been returned but not evaluated at the time of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3476855
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« Reply #14 on: December 07, 2013, 06:15:26 AM »

Model Number 37602
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the patient experienced a shocking or jolting sensation. It was noted that the physician had been aware for a couple of months that the patient experienced shocking in the chest area. At the time of current report, it was reported the patient was in the operating room. It was later reported that after the patient experienced shocking at the site of her implantable neurostimulator (ins), she had a subsequent revision. Impedance testing was performed and found that electrode impedances were high, but therapy impedance was normal. It was reported that the surgeon removed the ins, disconnected the extensions and saw there was tissue in the ports of the ins. The surgeon cleaned up the ports, reconnected the ins, and once reconnected there were no problems found with the impedance. It was further noted that after the revision the product issue resolved. The patient¿s status at the time of current report was noted to be ¿alive-with injury. ¿ further, it was reported the patient experienced pain at the ins pocket site.

 
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot# v688048, implanted: (b)(6) 2011, product type: lead. Product id 3387s-40, lot# v688048, implanted: (b)(6) 2011, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3452312
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« Reply #15 on: December 07, 2013, 06:16:28 AM »

Model Number 37603
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that as of the friday prior to this report there was an open circuit. The patient was having an entire system explant and re-implant on (b)(6) 2013. It was later reported that the patient had had changes in stimulation therapy and a lead fracture. It was unknown when the patient had the change in therapy or if there were any falls or traumas involved. It was noted that the extension had migrated down to the neck area and ¿may be frayed or something. ¿ there were high impedances and they were unable to program around the issue. It was noted that the manufacturing representative was unsure if both devices were involved. It was further noted that the patient was scheduled to have the leads replaced on (b)(6) 2013. Additional information received reported that on (b)(6) 2013 the patient was coming for evaluation of shock sensations in his right side which resolved with turning his left implantable neurostimulator (ins) off. The deep brain stimulator was interrogated including battery status and impedances. The right deep brain stimulator battery status and impedances were good. The left deep brain stimulator impedances were elevated from 10000 to 40000 on contacts 1, 2 and 3. It was noted that contact 3 impedances was greater than 40000 revealing an open circuit. The left ins was turned off and the patient was not to use until fixed. X-rays were reviewed and patient appeared to have a narrow/frayed area in the wire about 30 mm below the left jaw line. It was noted that there would be a replacement of left side lead and possibly both leads on (b)(6) 2013 which would be followed by a device and extension on (b)(6) 2013. Additional information requested but had not been received as of the date of this report.

 
Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3387s-40, lot# v813689, implanted: (b)(4) 2012, product type: lead product id: 37085-60, ,serial# (b)(4), implanted: (b)(4) 2012, product type: extension. Product id: 3387s-40, lot# v801518, implanted: (b)(4) 2012, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(4) 2012, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(4) 2012, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(4) 2012, product type: extension. Product id: 3387s-40, lot# v801518, implanted: (b)(6) 2012, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3442105
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« Reply #16 on: December 07, 2013, 06:17:10 AM »

Model Number 37602
Event Type  Death   Patient Outcome  Death,Other
Event Description
It was reported the patient had suffered 2 seizures on monday following a device replacement. The patient could not talk or walk, and a stroke had been ruled out. The patient was at the hospital. Per the reporter, the patient looked like he was having an electrical shock in his upper body and it brought him to the ground. The reporter had seen the patient "shudder" during programming sessions in the past, and the reporter was concerned the device was related to the problem. The patient's health care professional did not think the devices were working, but this was not confirmed and the devices had not been turned off. Additional information has been requested, a follow-up report will be sent if additional information becomes available.

 
Manufacturer Narrative
Product id 748251, serial # (b)(4), implanted: (b)(6) 2006; product type extension, product id 748251, serial # (b)(4), implanted: (b)(6) 2006; product type extension, product id 37642, serial # (b)(4), product type programmer, product id 3387s-40, lot # v009321, implanted: (b)(6) 2006; product type lead, product id 3387-40, lot # v00200,5 implanted: (b)(6) 2006; product type lead.

 
Manufacturer Narrative
(b)(4).

 
Event Description
Additional information received reported that the patient was fine when he went into the hospital to get the neurostimulators replaced, and he walked out of the hospital fine after the replacement. The patient was completely fine for a week after the replacement, and event went dancing. His speech had been hard to understand before the replacement, and after the replacement it was stronger and the patient stated "he had never felt better". On (b)(6), the patient was walking from the living room to the bathroom to get ready to go to the hospital to get his stitches out, when his wife heard a fall. She found that he had slid down the bathroom door and was sitting on the floor up against the door, experiencing an electrical shock. The patient was completely awake and alert, and experienced another electrical shock. The patient stated that he didn't know what happened, but it felt funny. The patient went to the hospital to get checked out, where he was seen by his neurosurgeon and a manufacturer representative. It was reported that one side of his body was drastically weaker than the other side, and on one side his leg turned in funny. It was reported that on one neurostimulator the settings looked normal, but on the other one the settings looked really high. The reporter wasn't sure which neurostimulator had the high settings, but she thought it was the left, and the settings were lowered. By (b)(6), the patient was in a semi-coma. While in the hospital, he was violent, was like in a "twilight sleep" and would lash out, wasn't talking, was barely eating and couldn't open his eyes. He was given a cat scan that ruled out a stroke, and blood and urine tests came back normal. It was noted that the patient had a urinary tract infection, but it wasn't bad. (b)(6) days later, the patient went to rehab for four to five days, because he was so aggressive and his eyes couldn't open, like they were stuck shut. The patient got worse in rehab, but it was noted that the hcp never shut off the neurostimulators because he believed it would make the patient's shakes really bad. The patient was taken on his levodopa, and he shook a little. (b)(6) weeks later, he was put into the psych ward and put on psych drugs because he was so aggressive in his sleep. The patient fell on floor a couple times and was then weaned off the psych drugs to make sure he wasn't having a reaction. He was then transferred to a hospice with the plan to transfer him to a home health or nursing home setting once he got better, however the patient died in the hospice. The death certificate listed the cause of death as failure to thrive and advanced parkinson's. Refer to mfr. Rep. # 3004209178-2012-03327.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2575695
« Last Edit: February 03, 2014, 01:19:42 AM by dennis100 » Logged
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« Reply #17 on: December 29, 2013, 04:09:41 AM »

Model Number 7426
Device Problem Explanted
Event Date 11/08/2001
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
Hcp reported "malfunction of battery. Shocking sensation - right. " the device was explanted and returned to the the mfr for analysis. A f/u report will be sent when add'l info is rec'd.

 
Manufacturer Narrative
H6: preliminary device analysis was not available on the date of this report. A f/u report will be sent when device analysis is complete.

 
Manufacturer Narrative
B 1 product problem should be checked - no adverse event. B 5 follow up with hcp revealed patient was experiencing stocking sensations in the right chest area causing a problem for pt. Interrogation of the device revealed "readings on the 2 contact revealed greater than 200 and less than 7" during screening of the electrode the patient experienced strong paresthesia down the arm and shoulder. The ipg replaced and they could find no tissue or fluid problems with the device. Patient has had no further problems since replacement and can use 4-5 volts on the 2nd electrode now. G 9 mdr number verification/correction 600003220010865, not 60000322001865.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=366638
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« Reply #18 on: December 29, 2013, 04:10:44 AM »

Model Number 3387
Event Date 10/30/2001
Event Type  Malfunction   Patient Outcome  Other
Event Description
New deep brain stimulator lead implanted. Pt noted shock like sensations when stimulator was turned on this fall. X-rays of the neck were taken and sent to medtronic, x-rays indicated that there was a fracture of the wire above the connector in the right lateral neck. Broken lead removed and replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=360883
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« Reply #19 on: December 30, 2013, 06:47:09 AM »

Model Number 7428
Device Problem Explanted
Event Date 02/15/2005
Event Type  Other   Patient Outcome  Other
Event Description
Hcp reported patient infection and loss of efficacy on left side. Patient symptoms included redness, swelling,burning and shocking around ipg when device was on. X-rays were normal. Exploration showed fluid build up which tested gram positive. The device was explanted and returned to the manufacturer for analysis.

 
Manufacturer Narrative
Preliminary device analysis was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=594688
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dennis100
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« Reply #20 on: December 30, 2013, 06:48:05 AM »

Model Number 7426
Device Problem Explanted
Event Date 11/08/2001
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
Hcp reported "malfunction of battery, shocking sensation right. " the device was explanted and returned to the the mfr for analysis. A f/u report will be sent when add'l info is rec'd.

 
Manufacturer Narrative
H6- preliminary device analysis was not available on the date of this report. A f/u report will be sent when device analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=436737
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dennis100
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« Reply #21 on: December 30, 2013, 06:49:28 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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dennis100
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« Reply #22 on: January 01, 2014, 04:52:00 AM »

Model Number 7426
Device Problem Device remains implanted
Event Type  Other   Patient Outcome  Other
Event Description
3m company representative reports the patient received a sligh shock when walking through the security gates a the public library. The reported interaction was between the medtronic ins and a 3m model 3802 library dectection system. No additional information on patient symptoms or outcome at the time of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=719643
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dennis100
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« Reply #23 on: January 01, 2014, 04:53:42 AM »

Model Number 3389
Device Problems Shock, electrical; Device remains implanted
Event Date 10/13/2006
Event Type  Injury   Patient Outcome  Other
Event Description
Patient reports an increase in pain, shocking sensations, and tingling in their face and tongue that goes down into fingers since being reprogrammed. The patient was experiencing a slight increase in tremor so underwent reprogramming. The patient reports a painful increase in stimulation during this reprogramming so the values were decreased back to the original settings. Since that date the patient is experiencing tingling pain in their face and tongue and the tingling goes down into the fingers. The patient reports turning the device off at night and receiving a jolt when turning the device on in the morning. When the device is turned on the tingling starts and continues until the device is off. No additional information on patient outcome or treatments were available at the time of this report. The manufacturer has contacted the hcp without a response to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=786262
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dennis100
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« Reply #24 on: January 01, 2014, 04:55:07 AM »

Model Number 7426
Device Problems Device remains implanted; Inappropriate shock
Event Date 09/01/2005
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Info provided by the pt to the hcp shows that since november 2005 they experienced shocks on the left and right sides when the ins is adjusted. Pt reported symptoms of increased numbness on the left side of the face and mouth, and difficulty talking and eating. The hcp indicated the date of onset of the reported event was october 2005. The physician indicated a diagnosis of essential tremor and pt symptoms of tremor with action and posture. The physician reported changing product electrode settings and using different amplitudes for the pt. No report has been received by the mfr of device explant and the product has not been received for analysis. The pt has reportedly recovered without sequela. The hcp also stated the pt has not been seen for several months and currently symptoms are unk.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=786422
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dennis100
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« Reply #25 on: January 03, 2014, 06:56:34 PM »

Model Number 74.8.2
Event Date 02/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Patient reported shock/tingling feeling from deep brain stimulator lead at right neck. Surgeon replaced lead in 2007. Original placement of lead was 2005.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=813545
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dennis100
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« Reply #26 on: January 03, 2014, 06:57:39 PM »

Model Number 7426
Device Problem Device remains implanted
Event Type  Malfunction   Patient Outcome  Other
Event Description
The patient reported having problems with coordination and balance and has been falling more often. The patient also indicated that she began experiencing shocking on the left side of her body three months ago. At follow-up, the hcp inactivated that side of the dbs system to investigate for possible breaks. After x-ray control, the physician determined there was no break visible and the system was reactivated with lowered settings. Subsequently, the incidents of shocking have stopped; however, the patient reports loss of symptom control on the left side of her body. Additional information has been requested from the physician. A follow-up report will be sent if additional information is obtained.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=835133
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dennis100
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« Reply #27 on: January 03, 2014, 06:58:39 PM »

Model Number 7426
Device Problem Device remains implanted
Event Type  Other   Patient Outcome  Other
Event Description
The pt reported that when the device amplitude is high enough to control the tremor, the pt has a "tingling, electrical sensation" in their tongue. No report of device explantation. An additional neurostimulator has been implanted since the date the event was reported to the manufacturer. 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=861582
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dennis100
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« Reply #28 on: January 05, 2014, 02:00:14 PM »

Model Number 7426
Device Problems Shock, electrical; Magnetic interference; Device remains implanted
Event Date 07/31/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient experienced shocking during an mri of the brain on 07/2007. A manufacturer representative turned the neurostimulator down to zero volts and off. The manufacturer representative checked the devices after they were turned back on and the devices were fine. The patient reported nausea and increased pulse rate approximately 30 minutes after the mri. An ekg was done and the results were slightly abnormal; blood tests were normal. Another ekg was performed and the results were normal. 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=906906
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dennis100
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« Reply #29 on: January 05, 2014, 02:01:30 PM »

Model Number 3387
Device Problems Shock, electrical; Explanted; Replace
Event Date 01/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The pt's spouse reported the pt has been experiencing an electrical discharge whether the neurostimulator is on or off. The pt is in extreme pain. The spouse stated the device was off at the time and the pt's settings were very high. Additional info was requested by medtronic from the health care professional regarding the reported event. The hcp reported the right lead had fractured. The pt's symptoms included no stimulation, discomfort or pain and shocking. The device was replaced and normal function was restored. No pt injury was noted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=966362
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