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Author Topic: Deep brain stimulator - Short Circuit  (Read 54236 times)
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dennis100
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« on: November 05, 2013, 11:53:24 PM »

Model Number IPGNEURO
Device Problem Electrical shorting
Event Type  Malfunction  
Event Description

It was reported a dbs patient being treated for (b)(6) disease had been having the leads "short circuit". The therapy had worked well in mitigating the symptoms until the issue with the leads. The patient was scheduled to undergo surgery over thanksgiving.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1950335
« Last Edit: December 05, 2014, 11:52:06 PM by dennis100 » Logged
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« Reply #1 on: November 05, 2013, 11:53:50 PM »

Model Number NEU_INS_STIMULATOR
Event Date 08/07/2012
Event Type  Malfunction  
Event Description

Additional information was received from the physician that reported there was a short circuit between contact 0 and 2, which caused the actual stimulation field around contact 1 to become narrower. The patient was reprogrammed from contact 2+ to 3+, but symptoms remained unchanged. During follow up, it was determined that the patient's symptoms were not related to the short circuit.
 
Manufacturer Narrative

 
Manufacturer Narrative

Product id: neu_unknown_lead, serial# unknown, product type: lead. Product id: neu_unknown_lead, serial# unknown, product type: lead. The actual event dates were not provided. This date is based on the date of publication of the article. D: patients were implanted with implantable neurostimulator model 7424 or 7426 and lead model 3387 or 3389. It was unknown which models this particular patient was implanted with. (b)(4).
 
Event Description

Literature: samura, k. , miyagi, y. , okamoto, t. , hayami, t. , kishimoto, j. , katano, m. , kamikaseda, k. Short circuit in deep brain stimulation. J. Neurosurg. 2012;117(5):955-961. Doi: 10. 3171/2012. 8. Jns112073. Summary: the authors undertook this study to investigate the incidence, cause, and clinical influence of short circuits in patients treated with deep brain stimulation (dbs). After the incidental identification of a short circuit during routine follow-up, the authors initiated a policy at their institution of routinely evaluating both therapeutic impedance and system impendence at every outpatient dbs follow-up visit, irrespective of the presence of symptoms suggesting possible system malfunction. This study represents a report of their findings after 1 year of this policy. Implanted dbs leads exhibiting short circuits were identified in 7 patients (8. 9% of the patients seen for outpatient follow-up examinations during the 12-month study period). The mean duration from dbs lead implantation to the discovery of the short circuit was 64. 7 months. The symptoms revealing short circuits included the wearing off of therapeutic effect, apraxia of eyelid opening, or dysarthria in 6 patients with parkinson disease (pd), and dystonia deterioration in 1 patient with generalized dystonia. All dbs leads with short circuits had been anchored to the cranium using titanium miniplate s. Altering electrode settings resulted in clinical improvement in the 2 pd cases in which patients had specific symptoms of short circuits (2. 5%) but not in the other 4 cases. The patient with dystonia underwent repositioning and replacement of a lead because the previous lead was located too anteriorly, but did not experience symptom improvement. In contrast to the sudden loss of clinical efficacy of dbs caused by an open circuit, short circuits may arise due to a gradual decrease in impedance, causing the insidious development of neurological symptoms via limited or extended potential fields as well as shortened battery longevity. The incidence of short circuits in dbs may be higher than previously thought, especially in cases in which dbs leads are anchored with miniplates. The circuit impedance of dbs should be routinely checked, even after a long history of dbs therapy, especially in cases of miniplate anchoring. Reported event: case 3. The patient had bilateral stimulation of the internal globus pallidus (gpi), and had a short circuit on the left side with electrodes 0-2. The patient experienced eyelid opening apraxia and neck dyskinesia. Impedance measurements were less than 50 ohms. Initial polarity settings were 1-2+, altered to 1-3+ with no change in symptoms. The cause of the short circuit was not identified. See attached literature article.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2860923

« Last Edit: February 04, 2014, 03:07:53 AM by dennis100 » Logged
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« Reply #2 on: November 05, 2013, 11:54:11 PM »

Model Number NEU_INS_STIMULATOR
Event Date 08/07/2012
Event Type  Malfunction  
Event Description

Literature: samura, k. , miyagi, y. , okamoto, t. , hayami, t. , kishimoto, j. , katano, m. , kamikaseda, k. Short circuit in deep brain stimulation. J. Neurosurg. 2012;117(5):955-961. Doi: 10. 3171/2012. 8. Jns112073. Summary: the authors undertook this study to investigate the incidence, cause, and clinical influence of short circuits in patients treated with deep brain stimulation (dbs). After the incidental identification of a short circuit during routine follow-up, the authors initiated a policy at their institution of routinely evaluating both therapeutic impedance and system impendence at every outpatient dbs follow-up visit, irrespective of the presence of symptoms suggesting possible system malfunction. This study represents a report of their findings after 1 year of this policy. Implanted dbs leads exhibiting short circuits were identified in 7 patients (8. 9% of the patients seen for outpatient follow-up examinations during the 12-month study period). The mean duration from dbs lead implantation to the discovery of the short circuit was 64. 7 months. The symptoms revealing short circuits included the wearing off of therapeutic effect, apraxia of eyelid opening, or dysarthria in 6 patients with parkinson disease (pd), and dystonia deterioration in 1 patient with generalized dystonia. All dbs leads with short circuits had been anchored to the cranium using titanium miniplate s. Altering electrode settings resulted in clinical improvement in the 2 pd cases in which patients had specific symptoms of short circuits (2. 5%) but not in the other 4 cases. The patient with dystonia underwent repositioning and replacement of a lead because the previous lead was located too anteriorly, but did not experience symptom improvement. In contrast to the sudden loss of clinical efficacy of dbs caused by an open circuit, short circuits may arise due to a gradual decrease in impedance, causing the insidious development of neurological symptoms via limited or extended potential fields as well as shortened battery longevity. The incidence of short circuits in dbs may be higher than previously thought, especially in cases in which dbs leads are anchored with miniplates. The circuit impedance of dbs should be routinely checked, even after a long history of dbs therapy, especially in cases of miniplate anchoring. Reported event: case 2. The patient had bilateral stimulation of the subthalamic nucleus (stn). The left lead had a short circuit with electrodes 0-3. Impedance measurements were less than 50 ohms. During the 5 years before the short circuit was identified, the patient experienced wearing off of therapeutic effect and freezing and propulsive gait during the off phase of medication, causing him to visit the hospital. Gait freezing may have resulted from a limited potential field due to the 2 anodes being involved in the short circuit. The patient also exhibited marked dysarthria and drooling. The patient's left implant delivered bipolar stimulation using contact 1 as a cathode and contact 3 as an anode. Therapy impedance was 794 ohms. Examination of system impedance revealed a short between contacts 3 and 0. Contact 0 was 6. 5mm under the midcommissural plane, suggesting a location in the ventral area of the stn. Altering the electrode setting to a unipolar stimulation using contacts 1 and 2 as cathodes led to the subjective alleviation of freezing and propulsion, but the sense of wearing off was not subjectively altered. These findings suggested that a short circuit between contacts 3 and 0 unexpectedly had limited the spread of the therapeutic potential field around contact 1. Short circuits were not suggested in radiographic examinations and were associated with no open circuits in a unipolar configuration. The cause of the short circuit was not identified.
 
Manufacturer Narrative

Product id: neu_unknown_lead, serial#: unknown, product type: lead; product id: neu_unknown_lead, serial#: unknown, product type: lead. The actual event dates were not provided. This date is based on the date of publication of the article. Patients were implanted with implantable neurostimulator: model 7424 or 7426 and lead model: 3387 or 3389. It was unknown which models this particular patient was implanted with. (b)(4).
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2860888

« Last Edit: February 04, 2014, 03:09:50 AM by dennis100 » Logged
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« Reply #3 on: November 05, 2013, 11:54:35 PM »

Model Number NEU_INS_STIMULATOR
Event Date 08/07/2012
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

Literature: samura, k. , miyagi, y. , okamoto, t. , hayami, t. , kishimoto, j. , katano, m. , kamikaseda, k. Short circuit in deep brain stimulation. J. Neurosurg. 2012;117(5):955-961. Doi: 10. 3171/2012. 8. Jns112073. Summary: the authors undertook this study to investigate the incidence, cause, and clinical influence of short circuits in patients treated with deep brain stimulation (dbs). After the incidental identification of a short circuit during routine follow-up, the authors initiated a policy at their institution of routinely evaluating both therapeutic impedance and system impendence at every outpatient dbs follow-up visit, irrespective of the presence of symptoms suggesting possible system malfunction. This study represents a report of their findings after 1 year of this policy. Implanted dbs leads exhibiting short circuits were identified in 7 patients (8. 9% of the patients seen for outpatient follow-up examinations during the 12-month study period). The mean duration from dbs lead implantation to the discovery of the short circuit was 64. 7 months. The symptoms revealing short circuits included the wearing off of therapeutic effect, apraxia of eyelid opening, or dysarthria in 6 patients with parkinson disease (pd), and dystonia deterioration in 1 patient with generalized dystonia. All dbs leads with short circuits had been anchored to the cranium using titanium miniplate s. Altering electrode settings resulted in clinical improvement in the 2 pd cases in which patients had specific symptoms of short circuits (2. 5%) but not in the other 4 cases. The patient with dystonia underwent repositioning and replacement of a lead because the previous lead was located too anteriorly, but did not experience symptom improvement. In contrast to the sudden loss of clinical efficacy of dbs caused by an open circuit, short circuits may arise due to a gradual decrease in impedance, causing the insidious development of neurological symptoms via limited or extended potential fields as well as shortened battery longevity. The incidence of short circuits in dbs may be higher than previously thought, especially in cases in which dbs leads are anchored with miniplates. The circuit impedance of dbs should be routinely checked, even after a long history of dbs therapy, especially in cases of miniplate anchoring. Reported event: case 1. The patient had bilateral stimulation of the subthalamic nucleaus (stn). The patient had a short circuit on the right side with electrodes 2-3. Symptoms included "wearing off" and dyskinesia. Impedance measurements were less than 50 ohms. Initial polarity settings were 1-2+, altered to 1-case+ with no change. There was no open circuit. Cause of the short circuit was not identified.
 
Manufacturer Narrative

Product id neu_unknown_lead, serial# unknown, product type lead; product id neu_unknown_lead, serial# unknown, product type lead. The actual event dates were not provided. This date is based on the date of publication of the article. Patients were implanted with implantable neurostimulator model 7424 or 7426 and lead model 3387 or 3389. It was unknown which models this particular patient was implanted with. (b)(4).
 
Event Description

Additional information was received from the physician that reported the stimulation field around contact 1 became 'narrower. ' the patient was reprogrammed to not use contacts 2 and 3, but the patient's symptoms remained the same. It was also reported that the patient developed an infection at the bur hole of the cranium and the lead was explanted in (b)(6) 2012. The patient's symptoms were gradually aggravated and the dbs lead was reimplanted (b)(6) 2012. The patient's symptoms were noticeably alleviated by stimulation using contact 2 instead of contact 1.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2860758

« Last Edit: February 04, 2014, 03:10:18 AM by dennis100 » Logged
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« Reply #4 on: November 05, 2013, 11:54:59 PM »

Model Number NEU_INS_STIMULATOR
Event Date 08/07/2012
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Additional information was received from the physician that reported the contacts that had short circuited were not used for the patient's stimulation. The patient's symptoms were due mainly to the positioning of the lead and it was noted there was no causal relationship between the short circuit and the patient's symptoms.
 
Event Description

Literature: samura, k. , miyagi, y. , okamoto, t. , hayami, t. , kishimoto, j. , katano, m. , kamikaseda, k. Short circuit in deep brain stimulation. J. Neurosurg. 2012;117(5):955-961. Doi: 10. 3171/2012. 8. Summary: the authors undertook this study to investigate the incidence, cause, and clinical influence of short circuits in patients treated with deep brain stimulation (dbs). After the incidental identification of a short circuit during routine follow-up, the authors initiated a policy at their institution of routinely evaluating both therapeutic impedance and system impedance at every outpatient dbs follow-up visit, irrespective of the presence of symptoms suggesting possible system malfunction. This study represents a report of their findings after 1 year of this policy. Implanted dbs leads exhibiting short circuits were identified in 7 patients ((b)(4) of the patients seen for outpatient follow-up examinations during the 12-month study period). The mean duration from dbs lead implantation to the discovery of the short circuit was 64. 7 months. The symptoms revealing short circuits included the wearing off of therapeutic effect, apraxia of eyelid opening, or dysarthria in 6 patients with parkinson disease (pd), and dystonia deterioration in 1 patient with generalized dystonia. All dbs leads with short circuits had been anchored to the cranium using titanium miniplate s. Altering electrode settings resulted in clinical improvement in the 2 pd cases in which patients had specific symptoms of short circuits ((b)(4)) but not in the other 4 cases. The patient with dystonia underwent repositioning and replacement of a lead because the previous lead was located too anteriorly, but did not experience symptom improvement. In contrast to the sudden loss of clinical efficacy of dbs caused by an open circuit, short circuits may arise due to a gradual decrease in impedance, causing the insidious development of neurological symptoms via limited or extended potential fields as well as shortened battery longevity. The incidence of short circuits in dbs may be higher than previously thought, especially in cases in which dbs leads are anchored with miniplates. The circuit impedance of dbs should be routinely checked, even after a long history of dbs therapy, especially in cases of miniplate anchoring. Reported event: case (b)(4). The patient had bilateral stimulation of the internal globus pallidus (gpi), and had a short circuit on the left side with electrodes 0-2. Impedance measurements were less than 50 ohms. The patient experienced dystonia deterioration. Initial polarity settings were 1-3+ altered to 1-3+ with no change in symptoms. An mri revealed that the lead was located in too anterolateral a position, suggesting stimulation of the globus pallidus externus. The lead was replaced and repositioned in the gpi with moderate alleviation of the patient's dystonia. The cause of the short circuit was not identified.
 
Manufacturer Narrative

(b)(4).
 
Manufacturer Narrative

Product id neu_unknown_lead, serial # unknown, product type lead; product id neu_unknown_lead, serial # unknown, product type lead. The actual event dates were not provided. This date is based on the date of publication of the article. Patients were implanted with implantable neurostimulator model 7424 or 7426 and lead model 3387 or 3389. It was unknown which models this particular patient was implanted with. (b)(4).
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2861892
« Last Edit: February 04, 2014, 03:11:23 AM by dennis100 » Logged
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« Reply #5 on: November 06, 2013, 11:47:04 AM »

Model Number UNKNOWN
Device Problems Fracture; Electrical shorting
Event Date 11/30/2009
Event Type  Malfunction  
Event Description

Literature: chan dtm, zhu xl, yeung jhm, et. Al. Complications of deep brain stimulation: a collective review. Asian j surg. 2009; 32(4): 258-63. Summary: this article presents an audit of all the pt's implanted with deep brain stimulation (dbs) between 1997 to the end of 2008 at one facility to assess complications arising from the 100 dbs electrode insertions and prevention of complications. Reportable event: one pt experienced a sudden loss of stimulation two months after an initial good response. Testing revealed high current drainage leading to the battery running out. Exploration revealed short circuiting due to an electrode fracture at the miniplate anchorage site. No pt treatment or outcome was reported. See literature article with mfr report #3007566237-2009-09382.
 
Manufacturer Narrative

(b) (4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566588

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« Reply #6 on: November 07, 2013, 08:34:23 PM »

Type of device: pulse generator
extension kit (left)
extension kit (right)
lead
lead, deep brain stimulator
Device brand name:    
Activia PC
Activa PC
Device manufacturer's name:    
Medtronic Neuromodulation
Date of this report: 12/22/2009
(mm/dd/yyyy)    

Describe the event or problem: Stereotactic placement of bilateral sub-thalamic nuclear DBS leads with micro-electrical recordings was completed. Placement of Activa PC generator and extension kits was done 1 week later. Approximately 2 months later our facility received a call from the provider office to report a short circuit with the impedance off. Configuration of programming changed so that those 2 circuits are not being used. This is the 3rd such problem our facility has seen in the past 6 months.

The device(s) may have
caused or contributed to: Potential for patient harm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=55851


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« Reply #7 on: December 06, 2013, 01:22:42 PM »

Model Number 7426
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Product id: 3387s-40, lot# v635198, implanted: (b)(6) 2011, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

 
Event Description
It was reported that low impedances of 8 ohms were measured on electrodes 0 and 1. It was noted the patient was having implantable neurostimulator (ins) replacement surgery and was receiving benefit from stimulation without side effect. The reporter stated the patient¿s healthcare professional decided not to troubleshoot the electrode and extension. Additional information received reported the cause of the short circuit was not determined. It was noted the date of the ins replacement surgery was (b)(6) 2013. Additional information was requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3446395
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« Reply #8 on: January 03, 2014, 12:34:34 AM »

Model Number 3387
Device Problems Replace; Tears, rips, holes in device, device material; Wire(s), breakage of
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
Preliminary device analysis results were not available at the time of this report. A follow-up report will be sent when product eval is complete.

 
Event Description
The rep reported that during the stage ii implant procedure, when the temporary cover was removed from each dbs lead, the number zero contact was compromised and lead wires were exposed. With difficulty, the physician connected both compromised leads to the extension; impedance readings in recovery were acceptable. The system was activated and the pt initially did well. A few months later, when therapy benefit stopped, a system check showed high impedance readings from the right-side components and a short circuit was detected from left-side components. Both leads were replaced and were returned to the mfr for analysis for suspected wire breakage. See mfr report number 6000153200701223.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=929864
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« Reply #9 on: January 03, 2014, 06:59:42 PM »

Model Number 7482
Device Problems Device remains implanted; Wire(s), breakage of
Event Type  Malfunction   Patient Outcome  Other
Manufacturer Narrative
(b)(4).

 
Event Description
Patient reported to the mfr on (b)(6) 2006 they were diagnosed with open wire (extension), as shown by x-ray exam. The patient provided additional information to the mfr on (b)(4) 2007 regarding symptoms that included rigidity, difficulty walking, and tightness felt over the battery for the past two months. The patient also indicated they were scheduled for follow up with the hcp during (b)(6) 2007 for an internal system check because the physician is concerned that an open or short circuit is possible. The date x-ray films were obtained and prior date of consult with the physician was not reported. No report of device explantation has been received. The product was implanted in (b)(6) 2006. It is unknown if both extension products were affected. Additional information has been requested from the hcp. See mfr report number 2649622-2007-00177.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2999653
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« Reply #10 on: January 05, 2014, 02:02:51 PM »

Model Number 3389
Device Problems Unknown (for use when the device problem is not known); Implant, reprogramming of
Event Date 10/11/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The manufacturer representative reported a problem with impedances; therapy impedances around 600-700 with current of 200ua which indicate a short. The device was programmed around this particular pair of electrodes that had a high current reading. Refer to medwatch report #6000153200704304.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=962078
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« Reply #11 on: January 05, 2014, 02:04:22 PM »

Model Number 3387
Device Problems Device remains implanted; Low impedance; Implant, reprogramming of
Event Date 10/25/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The hcp reported the patient experienced intermittent right leg cramping. Dystonia, dyskinesia and pain. Further investigation revealed a short circuit depleted the neurostimulator prematurely. Impedances on electrodes 0 and 1 were 59 ohms. The neurostimulator and one extension were replaced; impedances still indicated a short circuit (58 ohms and 301 ua). The representative programmed around the electrodes, using electrodes 2 and 3 instead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=971917
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« Reply #12 on: January 05, 2014, 02:05:28 PM »

Model Number 3389
Device Problems High impedance; Device remains implanted; Low impedance
Event Date 11/20/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The hcp reported, impedances >2000 ohms on all or some of the unipolar pairs. The pt is implanted bilaterally. The hcp used the same neurostimulator on different sides of the body which gave the hcp different battery readings and different problems. On the left side impedance readings indicated a short circuit; the right side appeared more normal. The caller also reported impedances <250 ohms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=969294
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« Reply #13 on: January 08, 2014, 04:04:00 PM »

Model Number 3387IES
Device Problems Device remains implanted; Low impedance
Event Date 08/27/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that during ins replacement impedance readings indicated that there was a short circuit, noting low impedance and high amplitude. The combination of 0 and 1 had an impedance <50 ohms and when 3 was removed the impedance was <50 ohms. The hcp noted that he was going to replace the pt's ins despite that there was a short circuit. The hcp understood the situation, but continued with the ins replacement. It appeared that the short was present before the replacement surgery. The short appears to be at the connection of the dbs lead and the extension. The patient did not experience any symptoms as a result of this event. Add'l 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 add'l info is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=919951
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« Reply #14 on: January 08, 2014, 04:04:48 PM »

Model Number 7426
Device Problems Shock, electrical; Device remains implanted; Implant, reprogramming of
Event Date 07/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The mfr rep reported the patient complained of bilateral intermittent shocking, up to 75 times a day, in various locations throughout the body. Troubleshooting was performed. The mfr suggested shutting off the device for a few days to see if the shocking subsided. The patient was turned off on a friday. The shocking/jolting sensations decreased to 3 or 4 times a day. The patient was reprogrammed the following monday and the device was turned back on. The patient stated the shocking/jolting sensation occurred less often. The hcp stated the patient is experiencing shocking less than five times a day. X-ray films looked good. Device interrogation suggested a possible short. The patient will be scheduled for more detailed x-rays. Refer to medwatch report #3004209178-2007-02884.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=910592
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« Reply #15 on: January 08, 2014, 04:05:37 PM »

Model Number 7426
Device Problems Circuit Failure; Replace; Improper or incorrect procedure or method; Implant, reprogramming of; Device Issue
Event Date 10/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient had required emergency replacement surgery; the dbs system was replaced for "equipment failure" (details were not provided), the spouse had indicated that the patient experienced "additional trauma" from the event; no symptoms were reported. The hcp had indicated to the representative that one lead had migrated; "the dbs lead pulled out (moved 10-20mm), which could have been activity related" (no details or dates were given). The representative had been present for initial programming; no issues were noted and the patient had indicated that symptoms improved. The representative followed-up with the physician; subsequent reprogramming had occurred "for a month or so" by the hcp (dates were not reported). The representative indicated there had been an open circuit. Impedance readings had revealed a "short" and the lead was replaced, it was unknown why the ipg was also replaced. The user facility had disposed of explanted product, the devices would not be returned for analysis. The patient outcome had initially been good with no subsequent change in status reported. Refer to mfr reports #6000153-2007-02723 and 6000153--2008-00930.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1004046
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« Reply #16 on: January 09, 2014, 09:23:49 AM »

Model Number 3389
Device Problems Circuit Failure; Device remains implanted
Event Date 01/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The representative reported a problem with delivery of dbs therapy (exact event date unk); there had been a loss of therapeutic benefit, whether stimulation was turned off or on. It was unk if the patient had suffered a fall or other trauma; results of x-ray exam had revealed the left-sided lead had fractured wires with impedance readings greater than 2000 ohms on all or some unipolar pairs. The connection point between the left-sided and extension appeared to have slipped (dislodged), downward from the neck area. The right-sided lead had an apparent short-circuit between electrode numbers zero and three; impedance readings showed less than 250 ohms. Options of reprogramming stimulation therapy and surgical revision would be considered. Additional information has been requested from the physician. Refer to mfr report #6000153200800170.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=979278
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« Reply #17 on: January 09, 2014, 01:57:14 PM »

Model Number 3389S
Device Problems Electrode contact(s), problem with; Material frayed; High impedance; Insulation, detached; Device remains implanted; Repair; Tears, rips, holes in device, device material
Event Date 04/22/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that the number three electrode contact had appeared frayed or damaged after removal of the accessory lead cap cover during the case. Exposed wires seen in the area contacted by the cap and the distal tip material had appeared stretched. The lead had separated easily from the temporary cap during the stage ii procedure; the surgeon had followed manufacturer instructions for use. The lead damage had been attributed to use of the temporary lead cap. The lead was subsequently inserted into the extension and the system connected after the surgeon cut-off the #3 contact in order to attach the extension and connect the system. Post-operative impedance readings obtained showed all unipolar electrode pairs were between 830 and 840 ohms, at 37 to 39 usec and a short circuit was suspected. Add'l impedance data obtained at 3v, showed values in the mid-500 range. No pt symptoms or injury was reported.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1052528
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« Reply #18 on: January 09, 2014, 05:08:18 PM »

Model Number 7482
Device Problem Low impedance
Event Date 05/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient experienced a loss of therapeutic effects. X-rays showed a possible short circuit in the extension (date not reported). Impedances were less than 50 ohms on electrodes 2 and 3. The device was not reprogrammed due to side effects (not specified). The hcp planned to remove the extension. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1058565
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« Reply #19 on: January 09, 2014, 05:09:12 PM »

CRIMINAL
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« Reply #20 on: January 12, 2014, 05:19:24 PM »

Model Number 3387
Device Problems Device remains implanted; Low impedance; Implant, reprogramming of
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported that the pt had a buzzing sensation on top of her head, on the left side of her face, and around her nose area. Sometimes, it increased in sensation. There was no known accident or incident related to the buzzing, but it was approx 2 months after a new neurostimulator was implanted on the right side and also around the time of a known lead short on 0-3. The hcp programmed around the short, but the buzzing continued. Palpation did cause the stimulation to change. Palpation also resulted in changes in sensation, when the stimulation was turned off. 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=1021227
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« Reply #21 on: January 12, 2014, 05:21:06 PM »

Model Number 3389
Device Problems Lead(s), breakage of; Replace
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: tabbal/safety and efficacy of subthalamic nucleus deep brain stimulation performed with limited intraoperative mapping for treatment of parkinson's disease 2007/61/3/119-27. This single-center study implanted 110 patients with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for the treatment of parkinson's disease. The objective of the study was to establish the safety and efficacy of bilateral stn-dbs performed during an expedient procedure with limited intraoperative mapping. The investigators used t2-weighted magnetic resonance imaging guidance to target the stn. Adverse events are reported. One pt required a lead replacement due to a short-circuit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019681

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« Reply #22 on: January 13, 2014, 02:36:10 AM »

Model Number 3389S
Device Problems Circuit Failure; Electrode contact(s), problem with; Device remains implanted; Tears, rips, holes in device, device material; Low impedance
Event Date 04/15/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
It was reported that the number three electrode contact had appeared frayed or damaged after removal of the accessory lead cap cover during the case. The lead had separated easily from the temporary cap during the stage ii procedure; the surgeon had followed mfr instructions for use. The lead damage had been attributed to use of the temporary lead cap. The lead was subsequently inserted into the extension and the system connected. Post-operative impedance readings obtained showed all unipolar electrode pairs were between 830 and 840 ohms, at 37 to 39 usec. Add'l impedance data obtained at 3v, showed values in the mid- 500 range, and a short circuit was suspected. No pt symptoms or injury was reported. Add'l info has been requested from the physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1047656
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« Reply #23 on: January 13, 2014, 09:38:09 AM »

Device Problem Low impedance
Event Date 03/28/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported intraoperative impedance readings did not match post-operative results. Impedance readings of <250 ohms were reported. Post-operative results indicated a short with connections 1 and 2 only; however, an impedance test showed these connections were fine. No pt symptoms were reported. The device was programmed around the "shorted" connection. The pt had good stimulation results without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1034892
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« Reply #24 on: January 13, 2014, 10:16:39 AM »

Model Number 3387
Device Problems Circuit Failure; Pipette, failure to aspirate
Event Date 04/01/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that subsequent to programming using electrode number three, impedance readings were <250 ohms, and an open (short) circuit was suspected. No pt symptoms were reported. Additional info has been requested from the physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1036117
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« Reply #25 on: January 14, 2014, 01:09:17 PM »

Model Number 7428
Device Problems High impedance; Other (for use when an appropriate device code cannot be identified)
Event Date 06/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The pt never had therapeutic effect after a new lead and extension implant. The lead was placed in the ventral intermediate thalamus. Bipolar impedances on electrode combinations 4-6, 5-7, and 6-7 were 3620 ohms and less than 15 microamperes. The hcp planned on opening the extension-lead site (and extension-implantable neurostimulator site if needed) to take apart, clean the connections and recheck impedances. The hcp later reported that a fluid short was diagnosed. A follow-up report will be submitted if additional info becomes available.

 
Manufacturer Narrative
Evaluation results: it is unk where the fluid short occurred. Fluid short.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1074720
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« Reply #26 on: January 14, 2014, 01:09:47 PM »

Model Number 7426
Device Problems Lead(s), breakage of; Replace; Wire(s), breakage of; Low battery
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
Lead and/or extension breakage was reported. The lead and/or extension was "shorting out". The battery was depleted.

 
Manufacturer Narrative
The neurostimulator, lead and extension were returned for analysis. Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1083469
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« Reply #27 on: January 14, 2014, 01:10:14 PM »

Model Number 7426
Device Problems Low impedance; Implant, reprogramming of
Event Date 07/31/2008
Event Type  Malfunction 
Event Description
After battery replacement, an impedance of 50 ohms and current of 575 microamperes was discovered, indicating a short circuit. The hcp was able to program around the short. Additional info has been requested. A follow-up report will be submitted if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1147379
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« Reply #28 on: January 14, 2014, 08:17:26 PM »

Model Number 7426
Device Problems Premature discharge of battery; Replace
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Final device analysis revealed no significant anomalies of the implantable pulse generator. The epoxy bond between the hybrid circuit and the battery terminal was broken. The electrical connections were intact; there was no impact to device performance. There were no electrical anomalies with the hybrid circuit that would cause a premature depletion. The implantable neurostimulator battery was found to be depleted. The difference between the actual battery life and the expected battery life may be related to the breached depression in the insulation on the extension to the #0 and #1 conductors.

 
Event Description
The patient felt the stimulation from the deep brain stimulator was unstable. The hcp suspected a short in the extension or early battery depletion. Prior to replacement, the hcp checked impedances because he suspected damage of the lead or extension (results not reported). The pulse generator and the extension were explanted and replaced. Intraoperatively there was no evidence of a short in the extension. The lead remained implanted. The hcp reported the pt outcome as 'recovered'.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1091506
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« Reply #29 on: January 14, 2014, 08:17:58 PM »

Model Number 7428
Device Problems Premature discharge of battery; Replace; Low impedance
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the patient's dbs device was reading unexpectedly low battery voltages. Impedance readings were <250 ohms. A short circuit was suspected. The patient had reportedly fell. Battery replacement and lead/extensions revision were being considered. The patient was seen by their following physician two weeks later. The patient was scheduled for battery replacement 2008. The leads and extensions would be checked during the replacement procedure to see if they needed to be revised as well. No patient symptoms were reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1216287
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« Reply #30 on: January 14, 2014, 10:37:14 PM »

Model Number 7426
Device Problems Other (for use when an appropriate device code cannot be identified); Unknown (for use when the device problem is not known)
Event Date 06/23/2008
Event Type  Malfunction 
Manufacturer Narrative
Short circuit.

 
Event Description
The patient experienced a loss of therapeutic effect, unrelated to a known incident or accident. The patient was seen by his hcp 3 days later who discovered a short on electrodes 2 and 3 (impedance not reported). The patient status was reported as 'unknown'; he was not able to withstand surgery. Additional information has been requested. A follow-up will be submitted if additional information becomes available.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1172903
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« Reply #31 on: January 17, 2014, 08:02:46 PM »

Model Number 7428
Device Problems Replace; Other (for use when an appropriate device code cannot be identified)
Event Date 01/06/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt reported that the lead was replaced in early 2009, due to a short; it was unclear which lead was replaced. 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=1317777
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« Reply #32 on: January 17, 2014, 10:33:52 PM »

Model Number 7428
Device Problem Premature discharge of battery
Event Date 02/01/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that the neurostimulator showed end of life even thought the programmed settings were within normal limits (no extra current was drawn from stimulator on purpose). The patient also experienced return of symptoms. Further troubleshooting was being considered to find out if there was a short circuit somewhere in the system causing premature battery depletion. No patient treatment or outcome was reported. Additional information has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1349724
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« Reply #33 on: January 17, 2014, 10:37:04 PM »

Model Number 7426
Device Problem Device damaged prior to use
Event Date 08/15/2006
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit. Analysis revealed the stimulator was functionally ok. Lead: multiple conductors wires were stretched; continually was acceptable. Extension: the majority of the extension body and outer insulation was twisted; the extension was functionally ok.

 
Event Description
It was reported the patient began having low voltage side effects at all contacts after a year of therapy. The physician suspected a short circuit between the leads. The problem was fixed by replacing the lead extender and battery.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1324319
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« Reply #34 on: January 18, 2014, 05:46:22 AM »

Model Number 7426
Device Problem Low impedance
Event Date 03/30/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that the patient's deep brain stimulation system (dbs) had a possible short circuit. Upon connecting the leads to the implantable neurostimulator (ins), the physician noted that the 0 and 3 contacts had and impedance of <50 ohms. The system was disconnected and cleaned for possible fluids that may have created a short circuit. After cleaning the impedances for the 0 and 3, contacts remained low; however, all other contacts were within normal range. The device was not activated. Reprogramming of the device will be performed in a neurology clinic at a later date. Additional information has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1425041
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« Reply #35 on: January 19, 2014, 12:30:34 AM »

Model Number 7426
Device Problems Low impedance; Low battery
Event Date 01/01/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
Bipolar impedances were 135 ohms on electrode combination 0-3, indicating a short. This was not a known device problem. The implantable neurostimulator was programmed to use electrodes 1-3. The patient was and still is receiving adequate stimulation. The implantable neurostimulator batteries were beginning to deplete. Please see mfr. Report # 3004209178-2009-03086.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1427352
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« Reply #36 on: January 19, 2014, 12:31:33 AM »

Model Number 37601
Device Problems High impedance; Replace
Event Date 01/28/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Final device analysis of the implantable neurostimulator revealed that there was no anomaly found - normal device function. Final device analysis of one extension revealed no significant anomalies; the extension was ok, but the insulation was melted/cut. Final device analysis of the second extension revealed a reliability non-conformance. There was a short between circuits (dry conditions). The connector area was intact; however, there was an intermittent short between circuits under the #2 connector. There was an intermittent short between the #2 and #3 conductors under the #2 connector. The cut ends of the #2 conductor were suspected to have shorted with the #3 conductor under the #2 connector.

 
Event Description
It was reported that the hardware was defective. The impedance was too high. There was no stimulation effect. The lead was replaced. The pt outcome was reported as ok.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1409818
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« Reply #37 on: January 20, 2014, 01:47:55 AM »

Model Number 3387S LEAD
Event Date 12/15/2009
Event Type  Malfunction 
Event Description
Stereotactic placement of bilateral sub-thalamic nuclear dbs leads with micro-electrical recordings was completed. Placement of activa pc generator and extension kits was done 1 week later. Approximately 2 months later our facility received a call from the provider office to report a short circuit with the impedance off. Configuration of programming changed so that those 2 circuits are not being used. This is the 3rd such problem our facility has seen in the past 6 months.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1564723
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« Reply #38 on: January 20, 2014, 01:50:00 AM »

Model Number 37612
Device Problems Degraded; Low impedance; Electrical shorting
Event Date 01/01/2009
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
The pt had to recharge frequently, for three hours every two days. Impedance for pair 1, 2 was 159 ohms and "out of regulation" messages were displayed. A short was confirmed. Ct revealed that one of the wires had "thinned" though it was not possible to determine if this was the cause of the short. It was possible to program around the short and the pt was receiving benefit. The device held charge at a more reasonable level; nothing was explanted or replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1565728
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« Reply #39 on: January 22, 2014, 02:53:47 AM »

Model Number 7426
Device Problems High impedance; Wire(s), breakage of; Electrical shorting
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4). This report is being submitted late due to a delay by a mfr employee. Training is in place.

 
Event Description
The pt reported jolting and pain in the faces. Impedance testing, x-rays and reprogramming were tried without success. It was reported that impedances were high and also that there were short circuits; it was determined that the lead was probably broken. The battery was also depleted, no longevity calculations were done; it was considered normal depletion. The system was replaced. The pt was reported to be doing much better.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614575
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« Reply #40 on: January 22, 2014, 08:28:14 AM »

Model Number 37601
Device Problems Bent; Low impedance
Event Date 02/01/2010
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that during stage 2 implant, low impedances between 50-150 ohms were noted on 10 and 11 contacts and shorted at <40 ohms. An inspection of the lead revealed that the distal portion was bent. It may have been due to screwing on of the lead cap during stage 1, but was most likely caused in retrieving the lead under the skin during stage 2. Stage 2 implant proceeded as normal and patient was closed up. The patient did not turn stimulation on until 2 weeks following implant. The patient was seen on (b) (6) 2010, for initial programming. The device was interrogated and impedance readings confirmed the short between contacts 10 and 11. In the initial programming session all contacts were explored for their therapeutic benefit. Contacts 10 and 11 did have therapeutic benefit, however, the optimal configuration for most beneficial effects with minimal side effects was 8+, 9-. This initial programming session resulted in settings of 8+, 9-, 2. 0 volts, 90 micro amps, and 185 hz. The therapy impedance reading was 1617 ohms with 1. 237 micro amps. The patient and physician were satisfied with the results.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1637580
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« Reply #41 on: January 22, 2014, 08:51:23 AM »

Model Number 7426
Device Problems Premature discharge of battery; Communication or transmission issue; Electrical shorting
Event Date 10/01/2009
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
(b) (4).

 
Event Description
The pt experienced a loss of therapy efficacy. Approx 3 weeks later, the pt was seen in clinic. No telemetry could be established between the deep brain stimulator and the physician programmer. It was determined that there was a short in one of the electrode combinations. This combination was inadvertently programmed to be used in therapy, causing premature deep brain stimulator battery depletion. The neurostimulator was replaced. Afterward, the pt's therapy resumed to a satisfactory level.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614500
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« Reply #42 on: January 22, 2014, 08:52:04 AM »

Model Number 7428
Device Problems Premature discharge of battery; Electrical shorting
Event Date 01/12/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The battery reached end of life after two years and seven months of use. The expected life was 3. 5 years. The programming printouts were reviewed and the highest stimulation settings were one cathode per channel and in both channels: 2. 8v, 90mcs, 135hz. The ipg was replaced. It was then noticed that both of the extensions had short-circuited; they were also replaced. The removed extensions were thrown away and will not be returned for analysis. The pt outcome was reported as "resolved".

 
Manufacturer Narrative
(b) (4). Final device analysis was not available at the time of this report. A follow-up medwatch report will be sent when the analysis is complete and/or when add'l info is rec'd from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614478
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« Reply #43 on: January 23, 2014, 08:11:35 AM »

Model Number LEADMVD
Device Problems Dent in material; Electrical shorting
Event Date 03/09/2010
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
The deep brain stimulator lead was tested in saline solution prior to implant and was ok. When it was implanted, the hcp determined that there was a short between 2 of the electrodes. Impedances between all other electrode impedances were normal. The lead was explanted and examined. There was a dent in the lead at the top of the depth stop adaptor screw. The screw of the depth stop adapter may have damaged the lead. The longer screw of the new depth stop gave less tactile feedback than the old one and was more difficult to judge how much to tighten it. The hcp opened a second lead and implanted it. The second lead was normal and the case proceeded without further delays. The problem caused a delay of about 15 mins.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1658524
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« Reply #44 on: January 25, 2014, 02:53:12 PM »

Model Number 7426
Device Problems Kinked; Impedance issue; Positioning Issue
Event Date 08/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4): the device has been returned to the mfr for analysis which is not complete as of the date of this report. A f/u report will be sent when the analysis is complete.

 
Event Description
It was reported lead was explanted due to infection. It was later reported lead was damaged during re-implant. The electrode was damaged while inserting lead through stim loc burr hole cover. The lead was kinked or crimped after insertion and impedances were abnormal. Physician indicated this resulted from sequence of surgical technique and not a faulty electrode. All impedance readings displayed as short circuits. Physician replaced the 1st lead with a new one. The new lead was connected to the current extension and battery. All of the impedances tested within the normal range. The pt's system will be programmed in the next few weeks. There was no pt injury and pt recovered w/o sequela. Add'l info will be provided when it becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1850865
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« Reply #45 on: January 25, 2014, 02:53:58 PM »

Model Number 37601
Device Problem Battery issue
Event Date 07/22/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the patient's device was replaced six months after implant due to end of service. Telemetry was performed on (b)(6) 2010 with the printout from the programmer showing the battery at 2. 85v. All impedances were less than 4000 ohms, except one combination used for therapy in the left hemisphere (pair 0,1) was less than 39 ohms. It was felt there was a short circuit issue and parameters were selected (pair 0,2) to give good symptom relief without use of pair 0,1. No further investigation of the lead was planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1814412
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« Reply #46 on: January 27, 2014, 02:40:36 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Product id 3387s-40 lot# v455827, implanted: 2010 (b)(6); product type lead product id 3387s-40 lot# v663231, implanted: 2011 (b)(6); product type lead product id 37092 lot# 249360004, implanted: 2010 (b)(6); product type accessory product id 37085-95, serial# (b)(4), implanted: 2010 (b)(6), explanted: 2013 (b)(6); product type extension product id 37085-95, serial# (b)(4), implanted: 2010 (b)(6), explanted: 2013 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient. (b)(4).

 
Event Description
The patient experienced a loss of stimulation and therapeutic effect. She had a loss of therapy since the ins was implanted. Impedance testing was done on (b)(6) 2013 and a short circuit was found on the left side of 55ohms. Premature battery depletion occurred, the battery only lasted 8 months. She was to undergo a battery change tomorrow, along with an extension change if the surgeon deemed necessary. It was clarified that the eos/eol message displayed. Eos was reached on (b)(6) 2013. The parameters were: left vim: 0+1-2-3- 4. 0v/150pw/120hz. Right vim: 0+1-2- 3. 3v/130pw/120hz. The second lead, 8-11 was not programmed 4. 45 months. The longevity calculation showed 7. 45 months and eos based on the 100ohms on the left side. Based off the printout of the patient¿s programmed setting the patient was really programmed with the following settings: left: 0+1-2-3- 4v/150pw/120hz. 56 ohms right: 8+9-10- 3. 3v/130pw/120hz. 1111ohms it was unknown when the short started, this was the first time looking at the settings. The (b)(6) 2013, interrogation reports showed: electrodes: 0/2 0/3 2/3 : 57ohms and 2/3 55ohms. The electrodes were tested at 0. 7v: c/11 8/11 9/11: 4500 and 5200 ohms. The left lead showed the short. It was unknown if the patient had a fall. The extension was going to be tested out first. The device printout also showed impedance measurements of 4549ohms with c/11, 9/11 4933ohms and 8/11 5188ohms. The company representative confirmed on (b)(4) 2013 that the ins and both extensions were replaced. Two out of the three short circuits were cleared. See manufacturer report # 3004209178-2013-21797 for the continued short circuit with the new devices.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3497599
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« Reply #47 on: January 27, 2014, 03:24:46 AM »

Model Number 37602
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant medical products: product id 3387-40, lot# j0511362v, implanted: (b)(6) 2005, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2013, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v095377, implanted: (b)(6) 2008, 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) 2008, product type: extension. (b)(4).

 
Event Description
It was reported that the healthcare professional explanted and replaced the left extension due to a shocking sensation experienced by the patient. It was noted that there was low impedance of 0<(>&<)>1 18 ohms. Diagnostics included impedance testing and x-rays. It was noted that the short circuit had been resolved and it should alleviate the patient¿s shocking sensation. The issue was not resolved. The patient¿s status was alive with no injury. Additional information received reported that the shocking was resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3514467
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« Reply #48 on: January 28, 2014, 09:00:49 AM »

Model Number 37601
Device Problem Low impedance
Event Date 11/22/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).

 
Manufacturer Narrative
Lead model 3389s-40, lot # v333260, implanted: (b)(6) 2009, explanted: na; lead model 3389s-40, lot # v276341, implanted: (b)(6) 2009, explanted: na; extension model 37085-60, serial # (b)(4), implanted: (b)(6) 2009, explanted: na; extension model 37085-60, serial # (b)(4), implanted: (b)(6) 2009, explanted: na; programmer model 37642, serial # (b)(4). The initial mdr was filed as mfr report # 3007566237-2010-10148. Additional review indicated the correct manufacturing site was site (b)(4).

 
Event Description
Additional review determined that the previously reported event occurred in (b)(6).

 
Event Description
Additional information received from the hcp reported that the patient had increased amplitude by 0. 1 on each lead. Afterwards, the patient felt that his balance had become worse, he had increased in falls, and he generally did not feel well. It was noted that the patient had also recently reduced his medications. The patient had turned the device off at the request of his hcp. The patient then visited his hcp for an interrogation, which showed that contact pair 8-9 had an impedance of 32 ohms. Contact pair case 2 on had an impedance of 84 ohms. The hcp traced back the patient's records and saw that the short on contact pair 8-9 had existed since (b)(6) 2009. X-rays were taken on (b)(6) 2010 and (b)(6) 2010, but the leads appeared intact and there were no obvious breaks. The patient's voltage was reduced to its previous level, but no further reprogramming was done as the contact pairs with the low impedances were not used in the patient's programming. It was reported that the patient did not require hospitalization, and there was no patient injury.

 
Event Description
Impedance between contacts 8 and 9 was 35 ohms. Using case, 8 or case, 9 and voiding the 8, 9 combination in programming was discussed. It was unk if reprogramming addressed the pt's therapy needs.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1937775
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« Reply #49 on: January 28, 2014, 09:02:27 AM »

Model Number 37612
Device Problem No Known Device Problem
Event Date 11/01/2010
Event Type  Malfunction 
Event Description
Received info, the pt and physician felt there was a loss of therapeutic stimulation once the battery was at 50-75% on a device implanted in 2009. Pt's neck tremor symptoms are returning, therefore, she now recharges every 2-3 days. The pt has very high settings in terms of amplitude and pulse width. Physician reported there may be a short on electrode 2 and 3 and 2 was essential for stimulation. Impedance readings were from 2582-5544 ohms. Pt is reported as suffering no injury. Add'l info has been requested and if received a f/u report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1950345
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« Reply #50 on: February 07, 2014, 12:25:14 AM »

Model Number 37602
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3389-40, lot# j0222859v, implanted: (b)(6) 2002,product type: lead. Product id: 3389-40, lot# j0222859v, implanted: (b)(6) 2002, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2002, product type: extension. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2002, product type: extension. (b)(4).

 
Event Description
It was reported that there was a possible problem with the implantable neurostimulator (ins). It was noted that the implantable neurostimulator (ins) depletion was being reported as premature. It was noted the last visit in (b)(6) of 2013, both batteries were >2. 90. It was noted that on the date of report the right ins was 2. 95 and the left ins was 2. 63. It was further noted that the settings of the left ins were ¿strange¿ at 0- ,1-,2+,3+; ¿2. 0/90/180. ¿ it was noted that impedance was 1097 with a current of 1. 848. It was noted that a longevity calculation was run with a result of 5-6 years. It was further noted that this only took into account impedance and not configuration. Additionally, it was noted that when an impedance check was done the healthcare professional (hcp) received a message stating that the amplitude delivered might be lower than intended (or something like that) and the hcp should consider reducing the voltage or lowering number of active contacts. It was noted that it made no sense to the hcp. The hcp attempted re-measuring and planned to take a photo but every subsequent measurement went through fine without the error message. It was noted that the hcp did a full impedance check and no problems were found. It was noted that the manufacturer representative conducted another longevity check at the same settings with the result of 5. 46 years to elective replacement indicator (eri) and 5. 71 years to end of service (eos). The manufacturer representative would look at past records for higher settings that may have caused the issue or any impedance data reflecting low impedance or shorts in the past. It was noted that it may have been an intermittent short. It was not known if the patient had any symptoms return in the past. Additional information received reported that the manufacturer representative left a message for the hcp to give a call and discuss the patient settings and whether or not there were any other issues. It was noted that the manufacturer representative had not heard back from the hcp. It was noted that per manufacturer's device registration, the device was explanted (b)(6) 2014.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3595748
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« Reply #51 on: March 31, 2014, 04:48:56 AM »

Model Number 7426
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that there was a short. It was noted that there were low impedances, less than 50 ohms on 0<(>&<)>1 0<(>&<)>2 and 1<(>&<)>2. Action required as a result of the event was reprogramming. Impedance testing was done. The issue was not resolved and the cause of the issue was unknown. The right lead was reprogrammed to contacts not affected by the short circuit. The implantable neurostimulator (ins) was programmed with 3- <(>&<)> c+. The patient had tremor and modest tremor control with new settings. Patient was alive with no injury and had less than 50% therapy relief at the lead location. The lead impacted by the short was implanted in the right sub thalamic nucleus (stn). The patient had a new thalamic lead implanted in the right ventral intermediate nucleus (vim) to better control his tremor in the left hand on (b)(6) 2014. Surgery for the right vim was scheduled prior to onset of the short circuit in the right stn lead. Additional information received reported there were no additional interventions taken or planned. The patient was not yet programmed and would be programmed in about 3 weeks or so from (b)(6) 2014. 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=3653662
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« Reply #52 on: April 10, 2014, 05:28:30 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Product id: 3387s-40, lot# va0fbun, implanted: (b)(6) 2014, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3387s-40, lot# va0f26b, implanted: (b)(6) 2014, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: extension. (b)(4).

 
Event Description
It was reported that there were low, out of range impedances. The patient was seen on the date of this report for initial programmer. It was unknown when the short impedance had occurred. Post-operative impedance reading was not available. Patient denied any falls or traumas. It was noted that the site looked intact. Impedances were c8 727 ohms, c9 718 ohms, c10 721 ohms, c11 727 ohms, 8/9 813 ohms, 8/10 812 ohms, 8/11 36 ohms, 9/10 35 ohms, 9/11 812 ohms, 10/11 813 ohms. It was later reported that there was a short circuit on all contacts. Surgical intervention was required and surgery was scheduled for (b)(6) 2014. Diagnostic testing/troubleshooting included impedance testing. Patient was alive with no injury. No patient symptoms were reported. It was later reported that the caller was in the revision procedure. Impedances were taken at 1. 5v on (b)(6) 2014 and were in normal range. It was noted that in the operating room prior to closing the patient at the time of implant impedances were c8 903, c9 778, c10 728, c11 683 and 8/11 1162. The healthcare professional had tried to do initial programming the week prior to (b)(6) 2014 and had found a short. On (b)(6) 2014 c/8 and c/11 were at 535 ohms and 8/11 was 38. The patient was not currently programmed on that side. The patient had not fallen or hit their head. The healthcare professional planned to disconnect the right extension from the implantable neurostimulator (ins), reconnect and test impedances. If impedances were still the same they planned to disconnect the lead and extension to test the lead. Additional information received reported that the patient had undergone revision on (b)(6) 2014. Patient had a short on his right side. Impedances were c0 538 ohms, c3 538 ohms and 03 36 ohms. It was determined that the lead was functioning properly and had normal impedances when tested with screening cable. The extension was replaced and the right side was tested after replacing the extension and impedances were within normal range. The patient would be programmed for the first time on the right side in the next few weeks following the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3700820
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« Reply #53 on: April 10, 2014, 09:41:43 PM »

Model Number NEU_INS_STIMULATOR
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id neu_unknown_lead, product type: lead. Product id: neu_unknown_ext, product type: extension. (b)(4).

 
Event Description
It was reported that the healthcare professional had had a case where there was a short at the implantable neurostimulator (ins)/connector. It was noted that pretty much anytime you were able to reproduce some symptoms with palpation/movement then it usually meant a short. It was noted the healthcare professional usually saw them just distal to connector over and unfortunately would have replace the leads in those cases. Surgeon had placed connector higher into portion of the scalp/skullin order to mitigate risk of short on the lead. It was noted that sometimes the screws could be tightened too much and this could cause the issue. 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=3697208
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« Reply #54 on: April 10, 2014, 09:42:24 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant medical products: product id 748251, serial# (b)(4), implanted: (b)(6) 2005, product type: extension; product id 3387-40, lot# j0527121v, implanted: (b)(6) 2005, product type: lead; product id 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3387s-40, lot# v006354, implanted: (b)(6) 2006, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension; product id 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension; product id neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2008, product type: lead; product id 8840, serial# unknown, product type: programmer, physician. (b)(4).

 
Event Description
It was reported that there were low, out of range impedances. It was noted that the patient fell in (b)(6) 2013. Therapy impedance before fall was 1058 ohms, 58ua and was 123 ohms, 372 ua after the fall. It was noted that other than the short circuit the patient was getting a good therapeutic response. It was noted that the patient may not be a lead replacement candidate. The device was at elective replacement indicator (eri). Manufacturing representative was meeting with the patient and healthcare professional on the date of this report. Additional information received reported the patient was scheduled for surgical evaluation of (b)(6) 2014.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3698928
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« Reply #55 on: May 11, 2014, 05:59:50 PM »

Model Number 7428
Event Date 10/24/2013
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
(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 battery depletion was normal. It was noted that actions required as a result of the event was surgical intervention. It was noted that the standard surgery procedure to product to replace neurostimulator battery. It was noted that it was unknown if any diagnostic testing or troubleshooting performed. It was noted that the patient status at the time of this report was alive with no injury. Additional information received reported that on the monday prior to explant the therapy impedances were 706 and 944 and current 227 and 171. It was noted that impedance measurements on the left side showed that there was a shortcut between el1 and el3. It was noted that chronic stimulation they use on the left side 0-positive and 1-negative. It was noted that this resulted in chronic stimulation having effectively 2 negative electrodes. It was noted that el1 was intended and el3 was short with el1 which may explain why the battery was emptying relatively fast. It was noted that chronic stimulation they used 6. 1 volts, 130 hz, and 210 micros on both sides. It was noted that the battery current drained measured in the therapy measurement mode was for both sides about 200 microa, which was high and this was part of the explanation why the battery was empty in a relatively short period. It was noted that since the patient was receiving good effect when the stimulator worked they decided to implant a new battery despite the fact that there was a short circuit between the electrode contacts on the left side. It was noted that the next step was going to be to find out where the problem was and then try to do it by systematic elaborate non-invasive impedance measurements potentially followed by invasive trouble shooting if evidence of the non-invasive trouble shooting suggested that is what was needed. It was noted that the ¿lifted bond wire issue¿ was not at play in this situation.
Manufacturer Narrative
Final analysis of the stimulator revealed no significant anomaly. The battery was not in the new condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3736853
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« Reply #56 on: May 11, 2014, 06:01:35 PM »

Model Number 7428
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
(b)(4).
Event Description
It was reported the battery had premature depletion. The battery was planned to be explanted (b)(6), 2014. It was unknown if there were any patient symptoms or complications associated with the event. Additional information reported the impedance values were within range. The voltage measured was 2. 6 volts and the capacity used was 40-85%. It was also noted with the patient¿s settings the device should not be depleted. It was confirmed that the patient had never experienced any kind of ¿shortcut¿ sensation during the study. Additional information reported that it was too early to say if the device was depleting faster than expected. The battery was about half way through the battery and it was possible it would reach its estimated longevity of 8 months. Additional information noted that the battery was now depleted and had a longevity of four months which was less than expected. Additional information noted that the patient was not doing well without their device and was to be explanted in a couple of days. Additional information reported that impedance measurements from the left side showed there was a shortcut between 1 and 3. In chronic stimulation they used left side 0 positive and 1 negative. It was noted this could explain why the battery emptied relatively fast. The battery current drain measured in therapy measurement mode was 200 microamps for both sides. It was noted this was high and part of the explanation on why the battery was emptied in a relatively short period. Due to the patient having had good effect when the stimulator worked, they planned to replace the battery and to investigate the short circuit at a later date. It was noted that due to the condition of the patient there was no time to perform systematic impedance measurements.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3748635
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« Reply #57 on: May 11, 2014, 08:46:27 PM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40 lot# v700663, implanted: 2011 (b)(6); product type lead product id 7482a40, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 3387s-40, lot# v475781, implanted: 2010 (b)(6); product type lead product id 37602, serial# (b)(4), implanted: 2013 (b)(6); product type implantable neurostimulator product id 7482a40, serial# (b)(4), implanted: 2010 (b)(6); product type extension. (b)(4).
Event Description
It was reported that the patient¿s primary cell devices had depleted and the healthcare professional wanted to switch the patient out to two rechargeable devices. There was an apparent short on combination 1 and 2 which had shown 7 ohms. Therapy impedance was 474 ohms. It was noted that combination 1, 2 was not used in the programming. It was further noted that the patient got almost 100% relief from her dystonia symptoms. Additional information received reported the implantable neurostimulator (ins) with the short had depleted somewhat faster than the other side. It was noted that impedance difference between left and right inss had accounted for that difference. Both inss were explanted and replaced with rechargeable devices on each side. The patient was doing well and receiving therapy. Reference manufacturers report number: 3004209178-2014-05889.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3736583
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« Reply #58 on: June 07, 2014, 10:05:05 AM »

Model Number 37602
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported there was an end of service (eos) message. It was noted the implantable neurostimulator (ins) was at eos and defective. It was noted the settings or impedances were not known at the time of report. It was stated they did not know when the eos appeared. It was further reported the patient had a short in their system due to the use of the patient¿s glasses. It was noted the patient¿s system was implanted about 10 years prior to report and they had always worn a pair of glasses that had pressed right up against the lead/extension connection. It was noted they could see the damaged area through the skin. It was noted the system was checked and a short was evident. It was stated the patient would follow up with their surgeon and prepare for a revision procedure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3800708
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« Reply #59 on: June 07, 2014, 10:06:14 AM »

Model Number 37603
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported there was battery depletion. It was stated there was low impedances of 49 ohms on electrodes 2 and 3. It was stated a replacement surgery was required as a result. It was noted the issue was not resolved. It was noted they may have tried to program around the short. It was noted the patient¿s device was at end of service (eos). It was stated the patient¿s status at the time of report was alive with no injury. It was noted no patient symptoms occurred. It was noted the device was at eos and impedances showed a short circuit on contacts that were utilized on 3 and 2. It was noted the device was replaced. It was further reported the date the eos was seen was on (b)(6) 2014. It was noted the patient did not know when the message began. It was stated the patient had used contact 3 and 2 with 5. 2v for therapy control. It was noted the patient received therapy after the generator change.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3821427
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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
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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
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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
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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
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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.

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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.

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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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« Reply #90 on: January 10, 2015, 02:34:25 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that there was a revision on the date of this report and the healthcare professional was seeing shorts. Just the batteries were involved in the revision; the patient had not wanted the extension revised at the time of this report. The first time there was a sign of the problem was 3-4 months prior to the surgery. The patient had turned the right battery off because of discomfort. The patient could not think of a specific incident or fall that may have damaged the system. The patient felt the programming made him uncomfortable. The impedance issue had first occurred preoperatively during impedance test, no stimulation difference had been felt by the patient. Impedance measurements before were c/0-3672, 0/2-4014 and 0/3-4517. The cause of the impedance issue was not determined. Both batteries were changed out and because therapy impedance was normal after battery change the patient¿s spouse had not wanted the extensions changed at that time to fix the open circuits that were not being sued in the patient¿s current program. The patient had never felt like the therapy had been great in the past several years since implant. Stimulation just kept getting higher and higher without increased benefit but with greater discomfort. Reference manufacturer¿s report number: 3004209178-2014-24139.

Manufacturer Narrative
Concomitant medical products: product id: 748240, serial# (b)(4), product type: extension. Product id: 3387-40, lot# s00185936, product type: lead. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 7482a40, serial# (b)(4), product type: extension. Product id: 3387-40, lot# j0118279v, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4337253
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« Reply #91 on: January 10, 2015, 08:47:28 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the patient had intermittent shorts, saw an elective replacement indicator (eri), and had the problem corrected even though the battery had a significant bounce back. No symptoms or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant products: product id neu_unknown_ext, serial # unknown, product type extension; product id neu_ unknown_lead, lot # unknown, product type lead; product id neu_unknown_prog, serial # unknown, product type programmer, physician. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4300393
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« Reply #92 on: January 10, 2015, 11:45:05 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
Product id 3387s-40, lot# v650839, implanted: 2011 (b)(6); product type lead product id 3387s-40, lot# v650839, implanted: 2011 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension. (b)(4).

Event Description
It was reported that during pre-operation a short was found. The implantable neurostimulator (ins) was being replaced due to normal battery depletion. When the patient¿s ins pocket was opened up to change out the ins, the healthcare professional (hcp) discovered that a breast implant had ruptured and there was silicon in the pocket on the deep brain stimulation components. The hcp clean up the silicone, implanted the new ins, and impedances were fine. The hcp suggested the implant puncture was not related to the device, but was due to age. The patient¿s ins pocket was on their right shoulder. Prior to the replacement surgery the patient mentioned having a couple of falls. There were no concerns about the ins battery longevity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4295195
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« Reply #93 on: February 07, 2015, 07:18:53 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant products: product id neu_ens_stimulator, serial # unknown, product type external neurostimulator; product id 7482a51, serial # (b)(4), product type extension; product id neu_ens_stimulator, serial # unknown, product type external neurostimulator; product id 3387s-40, lot # v818201, product type lead; product id 37085-60, serial # (b)(4), product type extension. (b)(4).

Event Description
It was reported that on the date of this report during an intra-operative troubleshooting they were using an external neurostimulator (ens) and twistlock to troubleshoot on the lead directly. When they had tested at 3. 0v, open circuit values on all of the 0 contacts and 1/3 and 2/3 were seen. Prior to the procedure the patient had a short on electrodes 2 and 3, 32 ohms. They disconnected and reseated the lead in the twistlock and it was noted that they were using the short stylet knob. Impedances were retested at 3. 0v following reconnecting and no values were out of range. They disconnected and had indicated they would replace the extension. The extension and the battery were replaced on the left side. All impedances were back in range and the patient was doing fine post-operatively. Patient therapy had resumed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4409316
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« Reply #94 on: February 07, 2015, 11:52:20 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient programmer showed an out of regulation (oor) message. The patient wanted to know if the oor message meant the implantable neurostimulator (ins) was no longer functioning because their symptoms had worsened considerably in recent weeks. The patient later reported the ins stopped working and they had an appointment scheduled for a replacement on (b)(6) 2014. A short in the patient¿s system had been found so the whole system was replaced. Following the replacement, the patient was receiving effective therapy.

Manufacturer Narrative
Concomitant medical products: product id 37642, serial# unknown, product type: programmer, patient. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4394483
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« Reply #95 on: February 07, 2015, 11:53:03 AM »

Model Number NEU_INS_STIMULATOR
Event Type Malfunction
Event Description
It was reported that on friday prior to the date of this report the patient had another sudden loss of therapy. On the date of this report the clinician programmer was showing an out of regulation (oor) message during programming and a short was showing between electrodes 1-2. Impedances on (b)(6) 2014 were c/0-991, c/1-564, c/2-559, c/3-767, 0/1-933, 0/2-944, 0/3-1388, 1/2-89, 1/3-757, 2/3-743. The patient was programmed using 1-2, 2. 7v, 120us and 185hz. Therapy impedance was 103 ohms, 23. 7mz. The patient had gotten a shock when electrode z was conducted at 3v and was not getting the shock at 0. 7v. No intervention or outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental mdr will be submitted.

Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 3387-40, lot# j0340295v, implanted: (b)(6) 2003, product type: lead; product id neu_unknown_ext, serial# unknown, implanted: (b)(6) 2003, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v017959, implanted: (b)(6) 2007, product type: lead; product id 748240, serial# (b)(4), implanted: (b)(6) 2007, product type: extension; product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4387766
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« Reply #96 on: March 07, 2015, 04:59:00 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id: neu_unknown_lead, lot# unknown, product type: lead. (b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

Event Description
It was reported the implantable neurostimulator (ins) prematurely depleted. End of service (eos) was displayed 10 months after implant. After testing impedances, a short circuit was found. The ins pocket was infected, inflamed, filled with fluid and very swollen. A culture of the ins pocket was taken and antibiotic treatment was necessary. The patient had less than 50 percent therapy relief. The ins was explanted. The patient status at the time of this report was alive with no injury. 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=4484708
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« Reply #97 on: March 07, 2015, 04:59:38 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3389s-40, lot# va01pn5, implanted: (b)(6) 2012, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37651, serial# (b)(4), product type: recharger. 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. (b)(4).

Event Description
It was reported the patient was having a revision because their healthcare professional (hcp) suspected that the electrode combination of 0 and 1 was shorted. Electrode impedances ran on the day of this report was 2766 ohms. Therapy impedance with 0 and 1 used was 2871 ohms. The manufacturing representative was not sure when the issue started or what the hcp saw to suspect there was a short. The patient had no shocking or jolting. The patient¿s wife thought the issue ¿comes and goes¿ and sounded intermittent. No symptoms 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=4503157
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« Reply #98 on: April 19, 2015, 02:46:28 AM »

Model Number 37602
Event Date 03/21/2013
Event Type Injury
Event Description
It was reported there was periodic shocking sensations extending from the patient¿s left parietal location down to their jaw. This only happened when the right brain lead was on even more so when they used contacts two and three together. A short circuit in the wiring was noted. Impedance was low between contact 2 and 3. The device was replaced and the event was considered resolved without sequelae. Information on shocking and short circuit was originally reported in manufacturer report #¿s 3004209178-2012-12357 and 3004209178-2012-12352.

Manufacturer Narrative
Concomitant: product id 3387s-40, lot# va04pwk, implanted: 2012-(b)(6), product type lead. Product id 37602, serial# (b)(4), implanted: 2012-(b)(6), explanted: 2013-(b)(6), product type implantable neurostimulator. Product id 748251, serial# (b)(4), implanted: 2007-(b)(6), explanted: 2013-(b)(6), product type extension. Product id 3387s-40, lot# va048wb, implanted: 2012-(b)(6), product type lead. Product id 748295, serial# (b)(4), implanted: 2007-(b)(6), explanted: 2013-(b)(6), product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4638973
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« Reply #99 on: April 19, 2015, 02:46:57 AM »

Model Number 37601
Event Date 02/25/2015
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient experienced ¿less than 50% therapy relief¿ in their ¿left hemibody¿ at the time of report. ¿immediately after implantation¿ impedance testing was performed and ¿showed a short on two contacts. ¿ the impedance testing records indicated bipolar electrode pair 1 and 2 had a low impedance value of 32 ohms (also reported as 52 ohms). It was noted that no impedance measurements had been taken during implant. Reprogramming the patient was reportedly ¿difficult,¿ but the patient ¿was receiving therapy¿ as of 19 days after initial report. A date to revise the patient¿s system was not yet planned; but a revision was expected as the patient¿s ¿neurologist was convinced [the patient] would be better with an intact system. ¿ additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant: product id 3708660, implanted: 2015-(b)(6), product type extension. Product id 3389-40, lot# unknown, implanted: 2015-(b)(6), product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4628331
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« Reply #100 on: May 09, 2015, 02:31:50 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that the manufacturer representative (rep) believed that there was a short in the system that was contributing to the implantable neurostimulator (ins) depleting too quickly. The patient was in a procedure at the time of the report and wanted to use an alligator clip to test the extension. There was no confirmation if a short was found or what the patient outcome was, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant products: product id: 3387-40, lot# j0225368v, implanted: (b)(6) 2002, product type: lead. Product id: 7438, serial# (b)(4), product type: programmer, patient. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2002, : product type: extension. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3389s-40, lot# va074ht, implanted: (b)(6) 2014, product type: lead. Product id: 748266, serial# (b)(4), implanted: (b)(6) 2002, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4669659
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« Reply #101 on: May 09, 2015, 02:32:30 AM »

Model Number 37604
Event Type Injury
Event Description
It was reported that ¿xxx¿ came up when the healthcare professional (hcp) ran therapy impedances three times. Voltage settings were changed, but that did not resolve the issue. No interleaving was being used and all electrode impedances were measured not be in normal range. The hcp was in the process of programming for therapy benefit and there was not anything that concerned them about the patient¿s therapy. The patient had four groups programmed the same using c+, 1- and they were using the second channel for recording. Stimulation was set at 2. 95v at the beginning of the programming session. One of the groups was programmed to 2. 8v and the other was at 3. 0v. The hcp met with the patient on the following day and a short circuit of 33 ohms was measured on electrode pair 0-2. The short had shown up intermittently in the past. Therapy impedances were measured to be 963 ohms. One port of the ins was being used for delivering stimulation and the other port had sensing lead-type of component that recorded activity and did not provide stimulation. Status of therapy was unclear. The hcp thought the patient was getting therapy from the left side ins, but may not be getting full benefit of therapy due to the right side programming issues. For the past six months, the hcp had been trying to optimize the patient¿s therapy due to the right side integrity issues due to impedances. A large different in impedances was noticed when impedances were run at 0. 7v and 3. 0v. The hcp was planning on replacing the extension on the right side. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4711516
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« Reply #102 on: May 09, 2015, 02:33:09 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that the patient had a loss of therapeutic effect. He felt a therapy ¿fall off¿ in the month prior to the report and had not had any significant falls or trauma. When he was lying on his right side his therapy would change. The manufacturer representative (rep) stated that the impedances had been ¿high¿ since implant, but then later stated they had been fine in the past. It was unclear when the impedance issues began and the actual values provided appeared to be within the normal range. The implantable neurostimulator (ins) was at end of service (eos) and the voltage showed 2. 83 volts. A longevity calculation was performed based on the patient¿s settings and noted that the battery should last five and a half years. Five days later the rep mentioned that the healthcare provider (hcp) was scheduling a replacement of the ins and extension. It was reported that a short circuit was discovered in the patient¿s system, which led to premature battery depletion.

Manufacturer Narrative
Concomitant medical products: product id: 7482a51, serial# (b)(4), implanted: 2007-(b)(6), product type: extension. Product id: 3387s-40, lot# v055961, implanted: 2007-(b)(6), product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4672397
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« Reply #103 on: June 08, 2015, 06:44:50 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Product id 37602, serial# (b)(4), implanted: 2012 (b)(6); product type implantable neurostimulator product id 3387s-40, lot# v192123, implanted: 2009 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2009 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v335517, implanted: 2010 (b)(6); product type lead. (b)(4).

Event Description
It was reported that there was a short in a wire and the patient got zapped when they turned their head. This first occurred in (b)(6) 2014, but also occurred in the fall, and recently. The implantable neurostimulator (ins) had showed low battery over a week prior to this report due to the short. A replacement surgery was scheduled for monday. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4752036
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« Reply #104 on: June 08, 2015, 06:45:27 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: 2011-(b)(6), explanted: 2014-(b)(6), product type: implantable neurostimulator. Product id: 3387s-40, lot# v727699, implanted: 2011-(b)(6), product type: lead. Product id: 37085-60, serial# (b)(4), implanted: 2011-(b)(6), product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported that the patient¿s whole system was being removed because of a short on the lead itself. The managing neurologist was unable to program around it. It was noted the patient had one lead implanted in their left vim. It was noted that electrode 0 and 3 showed 96 ohms. Refer to manufacturing report #3004209178-2014-05027 for the information pertaining to the patient¿s first ins that prematurely depleted due to the short.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4777649
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« Reply #105 on: June 08, 2015, 06:46:10 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37612, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 64001, lot # n356115, implanted: (b)(6) 2012, product type adapter; product id 3387s-40, lot # v353787, # implanted: (b)(6) 2009, product type lead; product id 3387s-40, lot # v347165, implanted: (b)(6) 2009, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 37651, serial # (b)(4), product type recharger; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2009, product type extension. Analysis of the extension ((b)(4)) found a distal end weld non-conformance, coil-straight wire crimp sleeve. The #3 coiled wire separated from the transition crimp.

Manufacturer Narrative
Concomitant medical products: product id: 37612, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 64001, lot# n356115, implanted: (b)(6) 2012, product type: adapter. Product id: 3387s-40, lot# v353787, implanted: (b)(6) 2009, product type: lead. Product id: 3387s-40, lot# v347165, implanted: (b)(6) 2009, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 37651, serial# (b)(4), product type: recharger. (b)(4). Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

Event Description
It was reported that the patient started complaining about right facial pulling and a shocking sensation in the chest region and cheek. It was noted that the patient fell last summer. The healthcare provider (hcp) met with the patient on (b)(6) 2015 and the combination of 2 and 3 was a short. The manufacturer representative (rep) then met with the patient on the day of the report and when they first ran impedances on the left implantable neurostimulator (ins) at 3 volts, all combinations with electrode 2 were high; greater than 7,000 ohms. The patient was programmed using case, 1, and 2. The rep had the patient do a left flexion and hold her head to the left and nothing was abnormal on the impedances. The rep had the patient lift her arm ¿life and pulled it back¿ while turning her face to the right side. This led to the patient¿s face on the right side starting to pull down and the shocking began as well in this position. The impedances were all within the normal range in this position and thus lower than the original measurements that were high. No lead fractures were noted and the cause was not determined. The patient was not receiving effective therapy and an extension revision was scheduled for (b)(6) 2015. After the revision the impedances were all within the normal range, except the combination of 2 and 3 which was 112 ohms. The patient was no longer experiencing a shocking sensation and was receiving effective therapy. The patient recovered without sequela.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4778467
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« Reply #106 on: June 08, 2015, 06:46:48 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Analysis of the extension found the body of the extension (s/n (b)(4)) was cut through and the product was segmented. Analysis of the lead (lot # va0rb07) found the conductor of the lead at the proximal end was broken and there was a short between circuits (dry conditions). Conductor #0 and #1 were broken at the connector weld sites. Circuits #0 and #1 were intermittently shorted when tested at the distal end.

Manufacturer Narrative
Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type extension. Product id: 3389s-40, lot# va0rb07, implanted: (b)(6) 2015 explanted: (b)(6) 2015, product type lead. Product id: 748266, serial# (b)(4), implanted: (b)(6) 2002, explanted: (b)(6) 2015, product type extension. Product id: 3387-40, lot# j0225368v, implanted: (b)(6) 2002, product type lead. Product id: 3389s-40, lot# va0rb07 implanted: (b)(6) 2015, explanted:(b)(6) 2015, product type lead. (b)(4).

Event Description
It was reported the patient had a return of symptoms. The lead and extension had performance issues and there was an open circuit on one electrode with a possible short on other electrodes. The manufacturing representative stated the lead tip and extension connection could be the cause of the short. The lead and extension were replaced. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4781011
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« Reply #107 on: July 15, 2015, 11:54:38 PM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Product id 7426, serial# (b)(4), implanted: 2011 (b)(6); product type implantable neurostimulator product id 3389-40, lot# j0313908v, implanted: 2003 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2003 (b)(6); product type extension product id 3389-40, lot# j0313844v, implanted: 2003 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2003 (b)(6); product type extension. (b)(4).

Event Description
It was reported that during an implantable neurostimulator (ins) replacement surgery, the healthcare professional (hcp) noticed there was damage to the left extension. There was a severed connection in the area near the ins and the ins was twisted in the pocket. The right ins was replaced since the ins was at end of service (eos). The left ins was not replaced because, the patient was not consented for an extension replacement. The patient was not having any therapy issues related to the left ins. Prior to surgery, the manufacturing representative did not do telemetry with the ins. After they surgery, the left ins was interrogated and a short was noticed on electrodes 0 and 3. Impedances of less than 50 ohms were measured on 0-3. The cause of the event was not determined. The left ins was turned off until the revision and the patient was experiencing symptoms on their right side. Another revision was planned on the left side to replace the extension and ins.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4868358
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« Reply #108 on: August 08, 2015, 09:58:52 AM »

Model Number 37601
Event Date 06/14/2015
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
Additional information received from the manufacturer representative (rep) reported that the shocking occurred on the patient¿s right side, or left brain. It was in the right shoulder and arm and considered sudden. It started on (b)(6) 2015 and occurred daily. Impedance measurements were taken and a short circuit was found on the electrode combination of 0 and 2. It was 90 ohms and the combination was being used in programming. In addition, the lead placement on that same side was not optimal, so an intended lead revision was scheduled for (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4892107
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« Reply #109 on: August 08, 2015, 09:59:36 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported that the patient¿s second deep brain stimulator was never turned on because there was a short in the wire. The device had never worked, it had shorted out. The patient had suffered with stroke like symptoms and headaches for years. The patient¿s daughter had received a phone call from the retirement home where the patient lived informing her that the patient had seemed to be having a stroke, they could not make sense of patient¿s communication, patient had a drooping face on one side and patient had gone to the hospital which had been about 2-3 years prior to the date of this report. At the hospital a test was done and they could not find anything wrong. The drooping face, unable to make sense of communication and could not find things had continued for about 6 weeks. The patient had seen her cardiologist who was unable to get a read on her pacemaker and thought it was the deep brain stimulator impacting the pacemaker reading, there was interference with the deep brain stimulator therapy. The patient noted that that could not happen since the deep brain stimulator was never turned on. A manufacturing representative checked the deep brain stimulator implant and found it to be on and causing all the symptoms the whole time. It was unknown how the device was turned on. The patient had headaches around lead area on the head. They had gone ahead and snipped the wires, removed the harness, and turned the device off. This had relieved headaches. The patient had had pretty debilitating symptoms from the device. The implantable neurostimulator (ins) and wires were still implanted but were disconnected so the ins could not be turned on. The patient had not had the relief she should have.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4888403
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« Reply #110 on: August 08, 2015, 10:02:22 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 7426, lot# serial# (b)(4) implanted: (b)(6) 2011, product type: implantable neurostimulator, product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2011 product type: extension. Product id: 3387-40, lot# l78076, implanted: (b)(6) 2000, product type: lead. Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 2000, product type: extension. Product id: 7482a40, serial# (b)(4) implanted: (b)(6) 2010, product type: extension. Product id: 3387s-40, lot# v488644, implanted: (b)(6) 2010, product type: lead. (b)(4).

Event Description
It was reported the patient had a shocking sensation, intermittent/erratic therapy, and pain around the implant area. The issue started suddenly five weeks prior to this report and had gradually been getting worse. The patient saw their healthcare professional on (b)(6) 2015 and the hcp said they had a short in the batteries and there was some kind of impediment coming from the batteries. The hcp wanted to replace the implantable neurostimulators (ins). When stimulation was turned off, the patient had tremor which they had not had for 15 years. When stimulation was turned on, the patient still had tremor, but it was sporadic and it went off on and on. Every time the patient turned the ins on, they were shocked. The patient stated they were disabled and had a hard time living. The patient was working to have the inss replaced. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent. Refer to manufacturer report #3004209178-2015-13679.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4925503
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« Reply #111 on: September 07, 2015, 07:01:38 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. (b)(4).

Event Description
A manufacturing representative reported the patient's wound was not healing properly where the lead and extension connection was located. The patient met with their health care provider (hcp) today for a wound check. A couple weeks prior to this report, the patient fell and went to the emergency room. The hcp in the emergency room had stapled over the head region close to the connector and lead location. During a revision to replace the extension and ins due to a short, irrigation and debridement was planned. The patient's indication for use is parkinson's dual and movement disorders. Following the revision, the patient had recovered without sequela. Refer to manufacturer report #3004209178-2015-16051.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5004484
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« Reply #112 on: September 07, 2015, 07:02:41 AM »

Model Number NEU_ENS_STIMULATOR
Event Type Injury
Manufacturer Narrative
Concomitant product: product id 3389s-40, lot # va0tf9y, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead; product id neu_unknown, serial # unknown, product type unknown. (b)(4).

Event Description
A health care provider (hcp) reported via a manufacturing representative that impedances were measured to be low for all electrodes. A single impedance values for all monopolar configurations and a single impedance value for all bipolar configurations led the hcp to the conclusion that the electrodes were short circuited. The hcp claimed the stimloc clamp squeezed the clamp too much, when the hcp tried to withdraw the stylet from the lead, the hcp had over tightened the screw of the ¿white plastic part¿ that holds the lead on the microdrive. When the hcp pulled the stylet, they broke the white plastic electrode cover where the stylet was fixed, stressing and damaging the lead just below the connector. All of the implanted components were tested from the implantable neurostimulator (ins) to the lead to identify the location of the short circuit. The lead was identified as the damaged part. The lead was not able to be replaced during the initial surgery so a revision was scheduled five days later using the previous planning and ct scans. After the lead replacement, the issue was resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4973843
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« Reply #113 on: September 07, 2015, 07:03:43 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/14/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 3389, serial# unknown, product type: lead. (b)(4).

Event Description
A health care provider (hcp) reported via a manufacturing representative that low impedances were measured on a lead during a follow up appointment. The patient was not getting much benefit from their system. Impedances were checked with a clinician programmer. Low impedances of 59 ohms were measured on electrode pair 0-1. "???" were measured on electrode pairs c-2 and 1-2. According to post operation ct scans, the lead appeared high so electrodes 0 and 1 were the best. The hcp assumed there was a short circuit between 0 and 1. No surgical intervention had occurred and it was unknown if intervention was planned. The issue was not resolved at the time of this report. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4973940
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« Reply #114 on: September 07, 2015, 07:04:26 AM »

Model Number 3389S-40
Event Date 07/16/2015
Event Type Malfunction
Event Description
The manufacturer representative (rep) reported that there was a short circuit on combinations 0 and 3, which was discovered intra-operatively. The impedance between 0 and 3 was 12 ohms. The lead was replaced after noting the short. The rep indicated that the health care professional (hcp) on the second lead noted he attached the depth stop. No outcome or intervention was reported regarding this event. If additional information is received, a follow-up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: neu_stylet_acc, product type: accessory. Product id: 3389s-40, lot# va0xc9r, implanted: (b)(6) 2015, product type: lead. (b)(4). Analysis of the lead (lot# va0uvrw) found a procedural non-conformance. The lead body outer insulation was damaged at the depth stop site.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4987821
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dennis100
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« Reply #115 on: September 07, 2015, 07:05:27 AM »

Model Number 37603
Device Problem Impedance issue
Event Date 02/01/2015
Event Type Injury
Event Description
A manufacturing representative reported that about a month after implant, electrodes 1 and 3 had a short and the patient's tremor had returned. The patient's indication for use is parkinson's dual and movement disorders. Impedances were measured to be fine after implant. About six weeks after implant, the short had resolved and the manufacturing representative was able to program those electrodes again so the patient received efficacy. On the day of this report, the manufacturing representative was meeting with the patient and the short had returned. A revision was done to replace the extension and the implantable neurostimulator (ins) due to the short draining the battery. The initial problem started after the patient had a fall. After the surgery, impedances were checked and they looked good. The low impedances had increased by 600 ohms. The manufacturing representative planned to meet with the patient tomorrow to program the ins. Following the revision the patient had recovered without sequela.

Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: 3387s-40, lot# va0p59t, implanted:(b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4) ,implanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted:(b)(6) 2015, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5004325
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dennis100
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« Reply #116 on: September 19, 2015, 03:08:39 AM »

Model Number 37612
Event Date 07/20/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# va069bc, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va069bc, 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. Product id: 37651, serial# (b)(4), product type: recharger. (b)(4).

Event Description
A manufacturing representative reported that a short was measured on electrodes 1/3 with an impedance of 130 ohms. The patient had no recent falls or trauma and they had no recent medical tests. No change in therapy was reported and the patient was getting the coverage they needed. The patient's indication for use is movement disorders. The electrodes with low impedances were used for programming therapy. The manufacturing representative had been contacted by the patient's health care provider (hcp) because they measured 150 ohms last week when they met with the patient. Impedance of 130 ohms was measured the day of this report. The manufacturing representative was not able to program around the short. The implantable neurostimulator (ins) recharging scheduled of charging for one hour every two days had not changed. At the time of this report, the patient planned to monitor things over time to see if the impedances change or therapy is compromised before doing any type of surgical intervention.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5022093
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