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Author Topic: Deep brain stimulator - Short Circuit  (Read 49253 times)
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dennis100
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« Reply #60 on: June 07, 2014, 10:07:35 AM »

Model Number 37612
Event Date 02/20/2014
Event Type Injury Patient Outcome Hospitalization
Manufacturer Narrative
(b)(4).
Event Description
It was reported that there were 1-2 bad electrodes isolated to one side of a bilateral deep brain stimulation (dbs) system. The patient was recharging often and there was high current drain with low impedance. The manufacturer¿s representative had met with the patient the day prior to report to perform impedance testing. Electrode impedances were as follows: c/0 745, c/1 734, c/2 952, c/3 1080, 0/1 44, 0/2 844, 0/3 1125, 1/2 844, 1/3 1125, 2/3 1035. The patient was currently in the hospital for bad gait and speech problems. The patient had been hospitalized for 10 weeks. Extensive reprogramming had been performed by the neurologist and only programming electrodes 0 and 1 seemed to help the patient. The patient was programmed on the shorted contact. It was stated that the patient¿s system was fine prior to hospitalization.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3830617
« Last Edit: January 10, 2015, 02:31:58 AM by dennis100 » Logged
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« Reply #61 on: June 07, 2014, 10:09:35 AM »

Model Number 37601
Event Date 05/03/2014
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported the patient had observed an elective replacement indicator (eri) message two days prior to report. It was stated that while the implantable neurostimulator (ins) was turned off it was indicated there was an eri message and the battery was at 2. 73 volts. It was noted that from impedance testing there appeared to be a short on the left side. It was further noted that the impedances between electrode 0 and electrodes 1 and 2 were 65 and 66 ohms respectively and the impedance between electrodes 1 and 2 was 67 ohms. It was stated the patient¿s right side impedance readings looked ¿fine¿ at the time of report. It was reported the patient¿s ins was 52% used at the time of report and the left side¿s therapy impedance was 65 ohms and the right side at 1361 ohms. It was noted that a longevity estimate of the ins with the current settings at the time of report and a therapy impedance of 100 ohms on the left side returned an estimated longevity of 21 months. It was reported the patient¿s ins was ¿only¿ implanted for approximately one year. Additional information reported the patient underwent an exploratory procedure ¿to test the integrity of the system. ¿ it was stated the operating physician opened the lead-extension site and checked the impedance of the lead using an external neurostimulator (ens). It was further stated the physician then reconnected the extension and checked the impedances using the patient¿s ins. It was noted ¿the short was resolved¿ at that time. It was reported the patient was ¿receiving normal therapy and all [impedance] measurements were within range¿ 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=3833619
« Last Edit: January 10, 2015, 02:32:27 AM by dennis100 » Logged
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« Reply #62 on: July 04, 2014, 09:18:43 PM »

Model Number 37603
Event Type Injury Patient Outcome Hospitalization,Other
Manufacturer Narrative
Concomitant products: product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator; product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator; product id 748251, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3387, serial # (b)(4), implanted: (b)(6) 2007, product type lead; product id 7438, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v805902, 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. (b)(4).

Event Description
It was reported that the patient had blacked out on monday prior to the date of this report. It was noted that the patient had episodes of dystonic seizures that lasted 45-50 seconds. It was further noted that the patient had blacked out a few times since monday prior to the date of this report. It was noted that someone at the hospital thought the right implant had a short. The patient would not get the device reset or checked for 2 weeks. The patient fell 2 months prior to the date of this report but they did not think this was related to the current incident. Patient¿s status was unknown. The patient was admitted to the hospital. It was later reported that the patient was ¿having seizures because of a faulty unit. ¿ this had started (b)(6) 2014. Therapy was not working as expected. There was a loss of therapeutic effect. Additional information received reported the patient was still having concerns with their device or therapy but was working with their doctor or manufacturing representative. The patient had an appointment on (b)(6) 2014.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3843992
« Last Edit: January 10, 2015, 02:33:05 AM by dennis100 » Logged
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« Reply #63 on: July 05, 2014, 01:59:36 AM »

Model Number 7428
Event Date 02/27/2014
Event Type Injury Patient Outcome Required Intervention,Hospitalization
Event Description
It was reported the patient had a short circuit which was causing battery depletion. It was also noted that the patient had been doing worse for three weeks prior to their visit. The patient had been having more symptoms then previously. The intervention involved replacing the stimulator. The event was considered resolved without sequelae and noted as related to the device and not related to the implant procedure. It was noted the event resulted in in-patient hospitalization. Additional information updated the patient as doing worse to the patient was having more obsessive compulsive symptoms and depressive symptoms. The etiology was noted as the stimulator.

Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3843159
« Last Edit: January 10, 2015, 02:33:29 AM by dennis100 » Logged
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« Reply #64 on: August 10, 2014, 06:26:58 AM »

Model Number 37603
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported that there was a there was a possible problem with the implantable neurostimulator (ins). It was noted that the patient was implanted in early may with bilateral devices. One device was able to be interrogated and turn on/off but the other device shows the on/off button on the clinician programmer greyed out. It was unknown why this was. The patient¿s stimulation had turned off on its own sometime between the week prior to the date of this report and the date of this report. Therapy impedance was 80ohms and battery voltage was 2. 935. The healthcare professional had originally tried to interrogate with the clinician programmer but still on/off was greyed out. No messages were seen when interrogating. Programming was switched to 1-2+ and nothing changed. The device was re-interrogated and there was an end of service (eos) indicated. Electrode impedance readings were c/0-1366, c/1-1366, c/2-2206, c/3-2376, 0/1-33, 0/2-3031, 0/3-3409, 1/2-3044, 1/3-3409 and 2/3-3862. Historical impedances were not available. It was later reported they were getting ready for surgery and the ins battery voltage was measured at 2. 95v. It was unknown if the healthcare professional had programmer about the short circuit electrode. It was later reported that there was low impedance of 32 on electrodes 0 and 1. Action required as a result of the event was reprogramming. Impedance testing was done. The cause of the issue was not determined and it was unknown if the issue had resolved. There was premature battery depletion and the action required as a result was a replacement. The issue was not resolved. There were no patient symptoms reported. Additional information was requested but had not been received as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3929816
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« Reply #65 on: August 10, 2014, 06:27:38 AM »

Model Number 37601
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 3387s, lot # v663227, implanted: (b)(6) 2011, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2011, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2011, product type extension; product id 3387s-40, lot # v674524 , implanted: (b)(6) 2011, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2011, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2011, product type extension. (b)(4).

Event Description
It was reported that there were low out of range impedances. An implantable neurostimulator (ins) replacement was done on tuesday prior to the date of this report. The replacement was due to the device being at its elective replacement indicator (eri). The patient had seen the healthcare professional on monday prior to the date of this report and had scheduled a quick replacement for the next day, tuesday. It was noted that when the doctor was closing they had checked impedances and contacts 1 and 2 were 27 ohms. Therapy was programmed for c+1- and the patient was getting some symptom relief. Therapy impedance was unknown. Impedance readings were c/0-842, c/1-512, c/2-512, c/3-769, 0/1-907, 0/2-909, 0/3-1284, 1/2-27, 1/3-809 and 2/3-809. Settings were pulse width of 60, rate of 145, amplitude of 2. 0, 1-c+ and 8-c+, pulse width 60, rate of 145 and amplitude was 3. 2 before implant but was set at 2. 8. The patient had had capsule side effect at 3. 2. Additional information received reported the cause of the issues was not determined however the values had indicated that the short was probably in the extension. Low impedances had not resolved, the healthcare professional had disengaged the extensions, wiped them off and reinserted but the impedance readings had remained the same. Values had indicated that the short was in the extension on channel 1 and the patient was not prepped for an extension replacement at the time of this report. The patient was programmer to the previous settings and was doing well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3927184

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« Reply #66 on: August 11, 2014, 01:15:38 AM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant products: product id neu_unknown_ext, serial # unknown, implanted: (b)(6) 2012, product type extension; product id 3389s-40, lot # v838904, implanted: (b)(6) 2011, product type lead; product id 7482a66, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3389s-40, lot # v838904, implanted: (b)(6) 2012, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator. (b)(4).

Event Description
It was reported that there were impedance readings of greater than 2000 ohms. There was a loss of therapeutic effect. It was noted that they were calling from the operating room. The patient had been taken in for a revision due to the loss of therapy. It was noted that there was no good medical history at the time of this report. Impedances were c/0-6473, c/1-6776, c/2-7193, c/3-7874, 1/3 and 0/3 were high and there was nothing less than 250. Therapy impedance and settings were not available. The patient was programmed at c+1-. They were going to start at the lead/extension with the twistlock connector and they were looking for connector block alignment, fluid or anything that was frayed. It was further noted that the loss of therapy had been sudden about a week or two prior to the date of this report. Impedances had been done directly on the lead at 1. 5v and all were greater than 2000 and at 3v all were in range. There was a kink seen in the lead when they had disconnected. The lead was being replaced. Additional information received reported that the lead was determined to have a short. It was kinked in part of the coil and now fluid was in the lead. The lead was replaced. It was reconnected to the system and all measurements were within speculations. The lead had been damaged during explant by the healthcare professional.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3937678
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« Reply #67 on: August 11, 2014, 01:16:16 AM »

Model Number 37603
Event Date 06/25/2014
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported, there was a low impedance issue and short circuit. They were unsure where the source of the low impedance was but they were told the day prior to report that they would explore the low impedance without any further detail. The patient seemed to not have obvious benefit from the deep brain stimulator (dbs) for dystonia. The device was going to be interrogated the day after report. They were going to explore surgically all of the connections the day after report. No patient symptoms were reported and the patient status at the time of report was alive with no injury. It was further reported, the manufacturer representative became aware of the situation the week prior to report. It was further reported, it was unknown when the impedance issue occurred. At pre-operative exploration the electrode impedance at 0. 7v at 0<(>&<)>2 was 54 ohms and at 3. 0v, 0<(>&<)>2 was 42 ohms. It was stated they first tested, the extension tail from the battery extension site and it showed 72 ohms at 0<(>&<)>2. The surgeon had opened the incision at lead/extension connection and saw a complete break. The insulation was intact but the coils were completely severed inside the insulation. All of the coils were severed per visual inspection. It was noted, the lead fracture was on the right lead. The surgeon would plan for future lead revision on the right lead. It was stated, the patient was fine and they did not receive therapy on right because, post-operative exploration impedance showed >40,000 ohms with the exception of c<(>&<)>0 which was 22,250 ohms. It was noted nothing was explanted on the day of exploration. Additional information received reported there was an impedance exploration case done 4 days prior to report which was reported. It was noted, the patient had highs and lows. Additional information received reported, the patient would have another revision but it had not been scheduled.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3949652
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« Reply #68 on: August 11, 2014, 07:53:12 AM »

Model Number 7426
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 748251, serial # (b)(4), implanted: (b)(6) 2004, product type extension; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension; product id 7426, serial # (b)(4), implanted: (b)(6) 2004, product type implantable neurostimulator; product id 748251, serial # (b)(4), implanted: (b)(6) 2004, product type extension; product id 3389-40, lot # j0337612v, implanted: (b)(6) 2004, product type lead; product id 3389-40, lot # j0537527v, implanted: (b)(6) 2005, product type lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2005, product type extension; product id neu_ptm_prog, serial # unknown, product type programmer, patient. (b)(4).

Event Description
It was reported there was an intermittent shocking sensation in the pocket and at various times. It was noted it happened intermittently since the therapy was initiated many years prior to report. It was stated they had tightening periodically at the skull but they were unable to give details on when and why. It was noted the issue was not resolved and the cause was not determined. It was stated the patient met with the manufacturer representative at the planned deep brain stimulator (dbs) battery replacement and possible extension revision one day prior to report. It was noted they had long-term intermittent shocking sensation at the ins pocket. It was stated the replacement was determined to not be necessary at the time of report as the patient only used the therapy intermittently at very low voltages. It was noted the replacement and extension exploration was cancelled. A pre-operative impedance measurement was taken and all was normal. The patient status at the time of report was alive with no injury. It was further reported the patient thought a smaller and thinner lead should be made and the patient programmer was too big and a small device should be designed. It was noted the extension pressed behind their ear and it would irritate their scalp. They had ¿electrical shorts¿ in their head since 2000 and as a result they would not turn the therapy on as often. It was noted the surgery was cancelled because the implant battery was bigger than their current implant. Additional information received reported nothing was planned and the patient was doing the same as when they arrived 2 days prior to report. Additional information received reported the patient did not have a 50% or greater symptom reduction and the cause of the event was not determined. It was noted reprogramming was not needed and no re-operation was performed. No troubleshooting or interventions were performed and the patient was not recovered and their symptoms and the issue were ongoing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3925139
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« Reply #69 on: September 06, 2014, 06:37:14 AM »

Model Number 37612
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported a patient experienced a sudden loss of therapy on the left side of his body and a significant decrease in recharge intervals. Impedance testing was consistent with a short circuit. Testing showed that it got significantly worse between the ¿(b)(6)¿. It was noted that nothing out of the ordinary occurred that may have led to a sudden loss of therapy. The right brain lead was turned down to zero to avoid drain on the battery. An x-ray report indicated the right brain lead was exiting the cap at a slight angle and there was a moderately tight figure of 8 coiling of the lead at the burr hole. It was noted that it was hard to see a clear kink. Because of the slightly suspicious appearance of the lead, the neurologist and the neurosurgeon performed an exploratory surgery on 2014-(b)(6) to investigate the integrity of the dbs system. The neurosurgeon commenced by opening the ipg site, and disconnecting the extension from channel 2. No evidence of damage or fluid ingress was seen. Impedance tests of the extension and lead using a multi-lead trailing cable (mltc) still showed a potential short circuit remained. The extension was refitted into channel 2. The neurosurgeon opened the lead/extension connection site at brain. The right lead was identified. The boot was removed and the connection was inspected. There was no evidence of damage or fluid ingress. The lead was disconnected from the extension. Lead impedance was tested using a twist lock cable. A potential short circuit still remained. They were aware that if a problem was found with the lead, the patient would have to return to theatre on another day to have a repeat stage 1 procedure. It was noted that the surgery was device related and the patient recovered. An impedance measurement of the right hemisphere at 0. 7v found contacts 8 and 10 was 122 ohms and contacts 9 and 11 was 81 ohms. An impedance measurement of the right hemisphere at 0. 7v found contacts 8 and 9 was 99 ohms, contacts 8 and 11 was 98 ohms, contacts 9 and 10 was 90 ohms, contacts 9 and 11 was 82 ohms, and contacts 10 and 11 was 89 ohms. An impedance measurement of the right hemisphere at 3. 00v found contacts 8 and 10 was 102 ohms and contacts 9 and 11 was 99 ohms. An impedance measurement of the lead extensions at. 7v found contacts 0 and 2 was 93 ohms. All impedances measured on contacts 4, 5, 6, <(>&<)> 7 were greater than 10000 oms. An impedance measurement of the right hemisphere at 3. 00v found contacts 0 and 2 was 85 ohms and contacts 1 and 3 was 73 ohms. An impedance measurement of the right hemisphere at 3. 00v found contacts 8 and 10 was 104 ohms and contacts 9 and 11 was 96 ohms. Additional information received reported a stage 1 lead revision was scheduled. The neurosurgeon reconnected the lead/extension and replaced a new boot over connection. The patient¿s device was switched on with only the left lead in use; the right lead was set to 0 volts.
Manufacturer Narrative
Concomitant: product id 3387-40, lot# 0205244329, implanted: 2011-(b)(6), product type lead. Product id 37085-40, serial# (b)(4), implanted: 2011-(b)(6), product type extension. Product id 3387-40, lot# 0205266616, implanted: 2011-(b)(6), product type lead. Product id 37085-40, serial# (b)(4), implanted: 2011-(b)(6), product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4018035
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« Reply #70 on: October 12, 2014, 02:50:40 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient had their implantable neurostimulator (ins) replaced (b)(6)-2014, and they also replaced some of the wiring because it was shorted out ¿or something¿ from the ear down. No outcome was reported for this event and 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.

Manufacturer Narrative
Concomitant: product id 37642, serial# (b)(4), product type programmer, patient. Product id 748251, serial# (b)(4), implanted: 2004-(b)(6), explanted: 2014-(b)(6), product type extension. Product id 3387-40, lot# j0437135v, implanted: 2004-(b)(6), product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4124022
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« Reply #71 on: October 12, 2014, 04:25:43 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that there was a short circuit which would be troubleshot intra-operatively on the date of this report during the battery change out. Pre-operative impedances for 2 and 3 were 30 ohms. C/2-678 ohms, c/3-672 ohms, c/1-860 ohms and it was unknown what c/0 was. The short had been reported 1. 5 years prior to the date of this report but had not been addressed until recently about 1 month prior to the date of this report when the patient had been seen by a different healthcare professional. No patient outcome was provided regarding the event. Further follow-up is being conducted to obtain this information. If additional information is received a follow-up report will be submitted.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v327567, implanted: (b)(6) 2010, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 37642, serial # (b)(4), product type programmer, patient. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4102736
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« Reply #72 on: October 12, 2014, 09:58:20 AM »

Model Number 3389S-40
Event Date 08/22/2014
Event Type Malfunction
Event Description
It was reported that the patient had a lead with a short circuit. The patient only had leads implanted and was going to have the implantable neurostimulator (ins) the following friday. The impedances were checked during the procedure and they saw a short on 0-3 combinations. They changed out the lead and this resolved the issue. There were concerns that the cause of the short was due to the lead being tightened down too hard on the microdrive. Eight days later information was received indicating that it was unknown what caused the short. The entire lead was removed and replaced with another lead. Impedances were checked twice prior to replacing the lead. The patient was doing well at the time of the report.

Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# va0llnh, implanted: (b)(6) 2014, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4092670
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« Reply #73 on: October 12, 2014, 12:21:51 PM »

Model Number 37603
Event Type Malfunction
Event Description
It was reported that the clinician programmer displayed end-of-service (eos) while the implantable neurostimulator (ins) battery voltage was at 2. 73v. The ins had been implanted about a year prior to the report and had been programmed to continuous mode. Impedance measurements were not available. However, it was suspected that a short circuit had been activated in the system. The patient experienced a relapse of their parkinson¿s symptoms, which were insufficiently controlled by unilateral stimulation. The device hadn't been explanted. If additional information becomes available, a follow-up report will be made available.

Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4089382
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« Reply #74 on: October 13, 2014, 12:53:50 AM »

Model Number 37601
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387s-40, lot# v637945, implanted: (b)(6) 2013, product type: lead; product id 3387s-40, lot# v637945, implanted: (b)(6) 2013, product type: lead; 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 that the healthcare provider (hcp) was worried that a short, found on the system the day of the report, would affect the implantable neurostimulator (ins) longevity. The hcp asked whether a short on a pair that was not programmed for use would affect the ins life. The patients last ins lasted 14 months. The following parameters were reported: right 10+ 9-, 5 volts, pulse width of 100, frequency of 180 hz, unknown and estimated impedance of 1000 ohms. Left 2+ 1-, volts, pulse width of 100, frequency of 180 hz, unknown and estimated impedance of 1000 ohms. It was estimated to have longevity of 16 months. Information regarding cause of impedance issue, any additional device malfunctions, and patient outcome has been requested which was not reported regarding this event. 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=4081811
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« Reply #75 on: October 13, 2014, 03:40:14 AM »

Model Number 37602
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389-40, lot# j0322216v, implanted: (b)(6) 2003, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension; product id 3389-40, lot# j0322216v, implanted: (b)(6) 2003, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. (b)(4).

Event Description
It was reported that in (b)(6) 2014 the patient had some problems with the deep brain stimulator system. There were increased impedance signals and the healthcare professional had felt that the system would need to be replaced in order to address the increased impedance levels which had indicated a possible short within the system. They had tried to change the patient¿s electrode configuration in order to not have to replace the system. They had been doing this for the past several months prior to the date of this report. On the date of this report the patient programmer was reading out of regulation range (oor). The patient¿s husband had changed the batteries on the patient programmer and the code was still appearing. The programmer would not let him do anything, the husband had tried to turn the device off and on. The patient was going to be seen by their healthcare professional at 3pm on the date of this report for reevaluation and possible adjustment of stimulators. It was recommended that therapy and electrode impedance measurements be taken at the appointment. On the right side the amplitude had been decreased to 2. 3volts, pulse width was 60 microseconds and the rate was 130hz. The electrode configuration was c+2-, impedance measurement was 1005 ohms and current measured was 2. 324 milliamperes. On the left side the amplitude was increased to 1. 6v, pulse width was 60 microsecond and the rate was 135hz. Electrode configuration was c+1-, impedance measured 2439 ohms and the current was 0. 683 milliamperes. It was noted that the battery reserve was bilaterally adequate. The patient had been originally implanted in 2003 and had a battery replacement in 2011. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4060135
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« Reply #76 on: October 13, 2014, 03:40:43 AM »

Model Number 37603
Event Date 06/11/2014
Event Type Malfunction
Event Description
It was reported that there was a short in regards to the patient¿s impedances. Electrodes 1 and 2 had resistance values of 33 ohms. Settings used were electrode 1 being negative, electrode 2 being positive, and an amplitude of 1. 5 volts. The patient was reported to get great results. The short was noted to have occurred since the implant date.

Manufacturer Narrative
Concomitant products: product id 37603, serial # (b)(4), implanted: (b)(6) 2014, product type implantable neurostimulator; product id 3389s-40, lot # va0hs82, implanted: (b)(6) 2014, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # va0huz3, implanted: (b)(6) 2014, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4059638
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« Reply #77 on: October 13, 2014, 03:41:14 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# v228940, 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 there was a power on reset (por). No error code was specified that would have accompanied the por. There were low impedances, 8 ohms. All monopolar and all other bipolar configurations other than 0 and 3 were normal. It was noted that the therapeutic settings were also normal. They were aware of the short circuit. The action required as a result of the event was an explant and replacement, which was completed on (b)(6) 2014. No diagnostic testing or troubleshooting was performed. Following the surgery the patient¿s family was informed that the device was reset to factory settings. They had not noticed any therapeutic deficit due to the device being turned off. The device had been functioning properly a week prior to the date of this report at the pre-operative visit. The patient had been welding after the pre-operative visit for a long period of time. It was noted that they guessed the device was adversely affected by the welding equipment. The patient was alive with no injury. There were no patient symptoms reported. Additional information received reported the manufacturing representative did not recall a message but the device was off and was programmed at 0. 0v, 210pw and 30hz. It was unknown how the patient was doing. The patient was receiving effective therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4058710
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« Reply #78 on: October 13, 2014, 03:41:44 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that the patient was seen on (b)(6) 2014 and the right battery was at end of service (eos), 2. 15 volts. The settings were 60us, 130hz, 2. 0v, 3+1- bipolar. The patient had previously been seen on (b)(6) 2013 and therapy impedance had been 1123 ohms, 2. 519ma. On (b)(6) 2014 impedances were c/0-greater than 40,000, c/1-485, c/2-2770 andc/3-485. Bipolar values were not available. Therapy impedance was 1392 ohms. It was noted that this had no seemed right as the patient had a short as indicated by the case values which was the reason for the dead battery. The patient had lost therapy as a result of the premature battery depletion. The patient had been implanted with two devices on (b)(6) 2012 and the devices had eventually completely depleted. Additional information was requested but had not been received as of the date of this report.

Manufacturer Narrative
Concomitant medical products: product id 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension; product id 3387s-40, lot# v022287, product type: lead; product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension; product id 3387s-40, lot# v022287, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4054969
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« Reply #79 on: October 13, 2014, 03:42:15 AM »

Model Number 37602
Event Type Malfunction
Event Description
It was reported that one of the patient¿s falls that had occurred about a year prior to the date of this report had most likely caused a short in the lead in the patient¿s brain. The healthcare professional did not think that the patient was a good candidate for surgery as the patient took plavax which was a blood thinner. The patient took this due to a heart attack that the patient had had 2 years prior to the date of this report. The patient had already had a battery replacement once but it had only lasted 3 months and the rechargeable system was recommended to the patient. Reference manufacturer¿s report number: 3004209178-2014-00651.

Manufacturer Narrative
Concomitant products: product id 37602, serial # (b)(6), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type implantable neurostimulator; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3387s-40, lot # v499735, implanted: (b)(6) 2010, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 3387s-40, lot # v020086, implanted: (b)(6) 2007, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37602, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type implantable neurostimulator. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4050976
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« Reply #80 on: November 08, 2014, 03:07:34 AM »

Model Number 37612
Event Type Malfunction
Event Description
It was originally reported on (b)(4) 2014 that the doctor called the manufacturer representative reporting oddities with programming. The doctor stated that when he went up half a volt on one side the current went from 2 to 10. The reporter thought the doctor went from 1. 5 volts to 2 volts on a bipolar setting. The doctor ran an impedance check and all looked fine. However, about two months later it was reported that there was a short in the bi-polar configuration. The healthcare providers (hcp) could not remember what electrode pair it was, but they recalled the impedances to be around 100 ohms. They reprogrammed the patient back to a monopolar configuration and he was doing fine and receiving effective therapy.

Manufacturer Narrative
Concomitant products: product id 37642, serial# (b)(4), product type programmer, patient; product id 37651, serial # (b)(4), product type recharger; product id 3389s-40, lot # v561099, implanted: (b)(6) 2010, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v388252, implanted: (b)(6) 2010, product type lead; 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=4162189
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« Reply #81 on: November 08, 2014, 03:08:29 AM »

Model Number 37601
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# v402883, implanted: (b)(6) 2010, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37092, lot# 240620002, implanted: (b)(6) 2010, product type: accessory. 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). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

Event Description
It was reported that the patient was not able to adjust stimulation. There was a ¿call your doctor¿ icon displayed. There was an out of regulation (oor) condition. The oor message was seen on the patient programmer. It was noted that the patient had recently had a battery change. The patient was able to clear the oor message and check the device. It was further reported the cause of the event was unknown and the event was attributed to the implantable neurostimulator (ins). It was noted the ins may be needed to be ¿resynchronized¿ in the office. It was noted the patient was scheduled for a follow-up appointment for (b)(6) 2014 for reprogramming and to resynchronize the ins. It was stated the patient did not require hospitalization. Additional information received reported the patient had a loss of therapeutic effect. The patient was last seen near the (b)(6) 2014. They would use the programmer on the first of every month to check the implantable neurostimulator (ins). They had cleared the oor and moved on. Therapy impedance was unknown. Impedances were given as: c0 692 c1 1327 c2 1197 c3 589. It was noted they did not receive baseline impedances for the patient, only impedances after the ins change out. The device was estimated to hit end of service (eos) at 2. 75 years approximately, but the patient¿s ins was already down to 2. 73v. They only used the left side of their system ¿ the right side was inactive. The parkinson¿s disease symptoms appeared to get worse and the patient had gone from 3 to 4 sinamet a day. Four days later, it was reported they were going to see the patient and do more exhaustive measurements including the patient in multiple positions andre-testing. It did not go to oor in that time period on (b)(6) 2014. Multiple impedance checks were performed with the patient¿s head in different positions as well as while the lead/extension connector was palpitated and the ins header. They focused on c<(>&<)>0, as that was the used electrode configuration, and they found the following: impedances stayed in the 665 range when the patient¿s head was looking straight, to his right, and up. The impedances improved to 1150 range when the patient looked left, down, and when lead/extension connection and ins header were being palpitated. The cause of the impedance issue was not determined. They never saw impedance out of range when they checked it. Due to the battery drain, a suspected periodic short was the thought on c+, 0-. No lead fractures we re found. They programmed around the suspected short with the addition of two additional groups. They changed just the electrode configurations and kept all the other parameters the same (90pw, 180 rate, 3. 9v). The patient tolerated both group b and c and they seemed to do well. They would check the device daily and report any oor messages or loss of efficacy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4170622
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« Reply #82 on: November 08, 2014, 08:05:51 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v065001, implanted: (b)(6) 2007, product type: lead. Product id: 3387s-40, lot# v065001, implanted: (b)(6) 2007, product type: lead. Product id: 748295, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 7482a95, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported that the patient saw a ¿call you doctor¿ end of service (eos) message on his programmer. He saw the message on the day of the report and was unable to adjust stimulation or get it to turn on. The patient experienced a sudden loss of therapeutic effect and stimulation. His left hand started shaking, so he grabbed the programmer to check the status and saw the message. Follow-up from the healthcare provider (hcp) reported that there was not 50% or greater symptom reduction. Reprogramming was not needed as the event was due to end of battery life. It was later reported to be premature battery depletion. Impedance testing was done and the ins showed a short on contact 1 and 3. The patient was reprogrammed in (b)(6) to these parameters and this may have been the cause of early depletion. The ins was replaced. Follow-up from the patient reported that he did have concerns with his device or therapy. The patient wanted to know why the ins had a shortage and did not last as long as the last one. This led to the patient questioning how long the new ins would last. However, he noted that new ins worked fine.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4143638
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« Reply #83 on: November 08, 2014, 08:06:30 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported the implantable neurostimulator (ins) had flipped. It was noted that the device was either not secured properly or was placed improperly during surgery. There was a coupling issue reported, antenna locate feature and a ¿short¿ physician mode recharge were performed but coupling did not improve. They were only able to obtain 0-2 coupling bars when they tried to recharge and the antenna locate feature reading was 22/32/36. The manufacturing representative met with the patient on the date of this report. They were able to demonstrate effective recharge and were on continuous mode. The patient did receive an x-ray on (b)(6) 2014 and reviewed on (b)(6) 2014 and they will have to be scheduled for a revision surgery in the future. No outcome was provided. 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 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type extension; product id neu_unknown_lead, product type lead; product id neu_unknown_prog, product type programmer, physician. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4136514
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« Reply #84 on: November 08, 2014, 08:07:10 AM »

Model Number NEU_INS_STIMULATOR
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v497075, implanted: (b)(6) 2010, product type: lead; product id 37085-95, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 3389s-40, lot# v497075, implanted: (b)(6) 2010, product type: lead; product id 37085-95, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

Event Description
It was reported there was an impedance issue of unknown value on electrodes 9 and 11. It was noted the patient had their battery changed in (b)(6) and two electrodes shorted after the case. Since then the doctor couldn¿t program around the shorts and had turned the deep brain stimulator (dbs) off. The patient status at the time of report was alive with no injury and they had a less than 50% therapy relief. The dbs was off so the patient couldn¿t function. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4132520
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« Reply #85 on: November 08, 2014, 08:07:46 AM »

Model Number 37601
Event Type Malfunction
Event Description
It was reported the device was at elective replacement indicator (eri) and so a longevity calculation was performed to estimate the implantable neurostimulator (ins) battery life. The eri message was at normal expected depletion. There was an impedance measurement that indicated a short on contacts 10 and 11. The contacts 10 and 11 were not used and the patient¿s therapy was good. They were unaware of when the short started. 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 neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_ext, serial# unknown, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4131231
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« Reply #86 on: December 05, 2014, 09:03:10 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant products: product id neu_unknown_ext, serial# unknown, product type extension. (b)(4).

Event Description
It was reported that the battery was at end-of-service (eos). It was however stated that, the battery voltage was at 2. 94v and should therefore not have triggered eos. The depletion was reportedly premature. Impedance checks ¿proved to be fine¿. An impedance of 400 ohms was noted. However, additional follow up indicated there was a short circuit on electrode pair 1, 3. The patient had been programmed to 3. 7v, 60 ¿s and 160 hz on 2 electrodes. Per longevity calculations, the implantable neurostimulator (ins) should have lasted 4 years. The patient had not been receiving effective therapy. The ins was consequently replaced. The impedance issue was not resolved with the replacement of the ins.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4274098
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« Reply #87 on: December 05, 2014, 09:03:42 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that after an implantable neurostimulator (ins) replacement procedure, a short circuit was ¿still evident¿ on electrode pair 1, 3 when impedances were checked with the patient¿s head in varying positions. There were seemingly no visible issues with the extension/ins connection. However, the patient still did not receive effective therapy. The patient¿s left extension was then replaced to hopefully resolve the short circuit issue. Initial impedance check with the new extension indicated normal impedances, with no short or open circuits. The patient was receiving effective therapy afterwards. Refer to manufacturer report 3004209178-2014-22107. Information suggested the short circuit existed prior to the implant of the ins on this report. The referenced report captures the issues experienced with the previous ins that led to its replacement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4274093
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« Reply #88 on: December 06, 2014, 12:15:34 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient¿s implantable neurostimulator (ins) was replaced several months ago. The patient thought the ins was replaced too soon and they were told that there was ¿some kind of short in the lead wire. ¿ high impedances were measured on contact one of the patient left brain. The patient further stated that during the replacement they went around the short. The patient¿s healthcare professional (hcp) told them the ins should last longer than a year with the ins in their chest. 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=4243075
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« Reply #89 on: December 06, 2014, 12:16:23 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant product: product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3389s-40, lot # va01pn5, implanted: (b)(6) 2012, product type lead; product id 3389s-40, lot # va01pn5, product type lead. (b)(4).

Event Description
It was reported that there was a short in the implantable neurostimulator (ins). There low impedance values of 34 on 0 and 1. There was premature battery depletion. It was unknown when the device had reached elective replacement indicator (eri) or when it had reached end of service (eos). It was also unknown if the patient was in cycling or continuous mode. The device was explanted and replaced on (b)(6) 2014. No diagnostic testing or troubleshooting was required. The patient was alive with no injury and patient symptoms included a return of their parkinson¿s symptoms on the right side implant. The issue was resolved and the cause of the issue was not determined. Replacement had resolved the short and the patient was receiving effective therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4226384
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