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Author Topic: Deep brain stimulator - Neck  (Read 28091 times)
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dennis100
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« Reply #30 on: January 18, 2014, 06:48:12 AM »

Model Number 7426
Device Problems Dislodged; High impedance; Replace
Event Date 04/02/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Results code other = extension. The device has been returned to the manufacturer for analysis, which is not complete as of the date of this report. A follow-up report will be sent when the analysis is complete.

 
Event Description
It was reported the pt experienced loss of therapeutic effect, tingling in the neck area, and poor symptom control. Impedance reading were >2000 ohms. The outer insulation of the extension was stretched and dislodged from the lead. The hcp noted that the lead/extension connection appeared to be lower down than expected. There was an abnormal appearance to the proximal end of the lead around the contacts. The extension was replaced. Impedance readings were all within normal limits after surgery. The pt reported that post surgery; therapy control and return with no side effects. The pt recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1372424
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dennis100
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« Reply #31 on: January 18, 2014, 07:08:13 AM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 04/01/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
It was reported that the pt experienced a painful shocking/jolting sensation at the right implantable neurostimulator (ins) site and interrogation revealed >2000 on some unipolar pairs. The right ins was eventually turned off. The pt also reported shocking and jolting on the left side of her neck, however the device was not turned off due to possible return of symptoms. It was reported that movement caused stimulation changes. At the time of this report the pt was hospitalized. No further information was available at the time of this report. Refer to manufacturers report #3004209178200903780.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1396005
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dennis100
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« Reply #32 on: January 18, 2014, 07:09:05 AM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 04/01/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that the pt experienced a painful shocking/jolting sensation at the right implantable neurostimulator (ins) site and interrogation revealed >2000 on some unipolar pairs. The right ins was eventually turned off. The pt also reported shocking and jolting on the left side of her neck, however, that device was not turned off due to possible return of symptoms. It was reported that movement caused stimulation changes. At the time of this report the pt was hospitalized. No further information was available at the time of this report. Refer to manufacturers report #3004209178200903781.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1396006
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dennis100
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« Reply #33 on: January 19, 2014, 12:44:27 AM »

Model Number 7426
Device Problems High impedance; Implant, reprogramming of
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
Two days after an extension revision (see mfrs report #s 3004209178-2009-04335 and 3004209178-2009-04336), the pt had neurological deficit symptoms which included being very rigid and immobile on the left side and the pt had speech changes. The pt had no stimulation and new pain in his left neck and chest. Impedance measurements were checked and some of the bipolar pairs were reading >4000 ohms (c/4, 4/6, 4/7). The default test values were increased to 3v and impedances measurements were as follows: 4/7>4000 ohms; c/4-2815 ohms <15 ua; 4/6-2815 ohms <15ua. The pt was programmed 4+, 5-, 6-. Even with reprogramming, the pt could only open and close his hand where as before he could walk. They were going to take an x-ray to see if they could see anything wrong with the lead. A revision was being considered. The pt's outcome was reported as "no injury". See mfr's report # 3004209178-2009-04341.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1465438
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dennis100
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« Reply #34 on: January 19, 2014, 05:30:25 PM »

Model Number 7426
Device Problem Electro-magnetic interference (EMI)
Event Type  Malfunction 
Event Description
It was reported that the patient experienced neck pain from possibly going through a metal detector. Additional information has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1476225
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dennis100
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« Reply #35 on: January 19, 2014, 05:31:00 PM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1403241
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dennis100
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« Reply #36 on: January 19, 2014, 05:32:13 PM »

Model Number 7426
Device Problems High impedance; Vibration
Event Date 04/01/2009
Event Type  Malfunction 
Event Description
The pt was unable to adjust stimulation. Pt symptoms associated with the event included 'feeling different' and trembling. The hcp reported that the pt couldn't figure out how to use the pt programmer. The pt programmer was replaced. The pt outcome was reported as 'no injury'. It was also reported that the pt experienced a vibration over the left deep brain stimulator unit and neck tightness. Impedances were within normal limits on the left sided device. Interrogation of the right-sided deep brain stimulation system revealed impedances greater than 2000 ohms on all electrode combinations except case to 1, 2, and 3. The pt hadn't fallen or had other trauma. There was no change in his parkinson's symptoms. No changes were made to the deep brain stimulator programming. X-rays of the skull and chest both showed no evidence of fracture of the cervical or intracranial components of the deep brain stimulators.

 
Manufacturer Narrative
This report is being submitted late due to a delay by a mfr employee. A process improvement plan and training are in place. Programmer was returned to the mfr for repair. The y2 crystal had to be replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1492188
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dennis100
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« Reply #37 on: January 19, 2014, 05:33:00 PM »

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

 
Manufacturer Narrative
(b) (4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1492124
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dennis100
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« Reply #38 on: January 20, 2014, 12:49:35 AM »

Model Number 37601
Device Problems Break; Device, or device fragments remain in patient
Event Date 11/17/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Tunneler/carrier.

 
Event Description
It was reported the tip of the tunneling rod broke off during a stage 2 dbs implant. The surgeon spent 2-3 hours attempting to locate the tip. The tip is not radiopaque, so it could not be seen by fluoroscopy. The surgeon attempted taking the pt to ct and sonogram but still was unable to locate the tip. After consultation with the pt's family it was decided no further attempt would be made to retrieve the tip. The piece remains in the pt's neck. The pt was doing fine following the surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1560761
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dennis100
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« Reply #39 on: January 20, 2014, 03:19:35 AM »

Model Number 7426
Device Problems Device remains implanted; Unit inactivated
Event Date 06/08/2009
Event Type  Malfunction 
Event Description
The pt complained that she was feeling vibrations, tingling, and current going from her left stimulator up her neck. It was also reported as a shocking or jolting sensation at the stimulator location. No stimulation changes were noticed with movement. Palpating the stimulator caused the sensation to change. Impedance measurements were normal. The device was turned off and the sensation persisted. No outcome was reported. Additional info has been requested from the healthcare professional.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1476539
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dennis100
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« Reply #40 on: January 21, 2014, 12:17:45 AM »

Model Number 7426
Device Problem High impedance
Event Date 11/01/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
The implantable neurostimulator system was revised (reason not reported). Impedances were checked intraoperatively and were fine. The pt experienced a loss of stimulation therapy. Impedances were greater than 2000 ohms on electrode #2. The pt had dystonia accompanied by pulling of his neck. 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=1562954
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dennis100
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« Reply #41 on: January 21, 2014, 12:20:05 AM »

Model Number 7426
Device Problem No Information
Event Date 06/29/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported the patient experienced a catatonic contraction with her head and shoulder - leaning to the right. The hcp felt that the patient experienced an element of dystonia in the neck area that was not present prior to the implant. The muscle contractions were significant enough that it was interfering with the patient's gait, and has caused her to fall several times. A botox injection improved things slightly. The patient's device was reprogrammed and had another reprogramming appointment scheduled for the following week. 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=1563088
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dennis100
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« Reply #42 on: January 21, 2014, 12:24:16 AM »

Model Number 7428
Event Date 01/01/2009
Event Type  Malfunction 
Event Description
The pt was pulled by a speed boat while sitting on an inflatable chair. The ride was jarring. Afterward, the pt felt unconformable. Her left hand was going into spasm and her tongue was twisting, making it difficult for her to speak. The pt felt disoriented. Interrogation with the pt programmer revealed that the amplitude of the deep brain stimulator unit was set to 1. 6 and 1. 1 volts. Prior to the ride it was 0. 5 and 0. 6 volts. The upper limit of stimulation was set to 1. 0 volt. The pt's condition had returned to normal once the device amplitude was turned back down. The pt had pain in her neck where the wires were. The pt had not had problems with her deep brain stimulator after participating in water sports before.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1521807
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dennis100
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« Reply #43 on: January 21, 2014, 12:26:42 AM »

Model Number 7428
Device Problem Dislodged or dislocated
Event Date 05/10/2008
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
The patient experienced painful mechanical irritation in her left neck area in 2008. The deep brain stimulator was dislocated. The patient was hospitalized and the neurostimulator was surgically revised. The serious adverse event resolved the following month. As a result of a review of our mdr procedure with fda, it was determined that events in clinical studies should have been reported with in a 30-day time frame. We are filing these late reports.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1520169
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dennis100
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« Reply #44 on: January 23, 2014, 08:36:04 AM »

Model Number 37601
Device Problem No Known Device Problem
Event Date 04/21/2010
Event Type  Injury   Patient Outcome  Other
Event Description
Eight months after implant of deep brain stimulation (dbs) device, the stimulation was working well but the pt was complaining that he felt traction from the extensions in his neck. At physical examination, the extensions were visible under the skin and it appeared the neurostimulator was pulling on them. The head of the pt was forced into an abnormal posture, flexed forward and to the right. The pt had gained weight; the surgeon believed this may have caused some move of the neurostimulator location. On (b)(6) 2010, the pt was taken to surgery to explore the neurostimulator pocket. The device was placed higher in the abdomen. After the surgery, it seemed the traction on the extensions was not relieved. The pt still felt the traction that forced his head to be flexed forward. On (b)(6) 2010, the pt is taken to surgery again to explore the distal part of the extension. The neurostimulator was already placed higher and there was no traction on the distal part of the extension and the connection to the neurostimulator. The surgeon explored the extension distal to the stimulator. No traction was observed. The surgeon decided to disconnect the cuff fixation from the extension. After surgery, the traction on the extensions was not relieved, the pt still felt the traction in the neck area. On (b)(6) 2010, the right retro auricular area is explored, where the lead and extension connect. The extension was retracted for 30 cm and re-tunnelled to the left infra-clavicle area. The extension used (95cm) was long and it made a loop at the right clavicle side and a loop at the left clavicle side, expecting this would relieve the traction the pt experienced in his neck. After surgery everyone observed that the head of the pt is still forced to an abnormal posture and the extension was visible under the skin like it was pulling on the head. On (b)(6) 2010, the original 95cm extensions were replaced with new extensions of 65cm. The new extensions were tunnelled through the left retro-auricular area and connected the stimulator placed in the left infra-clavicular area. After surgery, even though the old extensions had been removed, the traction of the head of the pt was still present. It seemed that the pt developed a thick fibrous sheath around the original extensions. This fibrous tissue was so prominent that it forced the pt's head into an abnormal posture as if it is pulling the head down. The pt was reported to be ok after the last procedure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1705667
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dennis100
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« Reply #45 on: January 26, 2014, 02:20:25 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/11/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: blomstedt p, sandvik u, tisch s. Deep brain stimulation in the posterior subthalamic area in the treatment of essential tremor. Mov disord. Jul 30 2010; 25(10): 1350-1356. Summary: to evaluate the posterior subthalamic area (psa) as a target for deep brain stimulation (dbs) in the treatment of essential tremor (et). Twenty-one pts with et were included in this study from 2004-2007. The group consisted of seven women and 14 men; with a mean age of 63. 6 years. All pts were evaluated before and 1 year after surgery. Dbs in the psa resulted in a marked reduction of tremor. A marked microlesional effect was noticed in 83% of the pts on introduction of the electrode, and due to continued abscence of tremor, the stimulation did not need to be started in 35% before discharge from the hospital. No pt had simultaneous stimulation of two ipsilateral electrodes. No severe or permanent complication occurred. No hemorrhages or infections were encountered in this series. Reportable event: two pts experienced strain in the neck; a revision of the extension cable was performed.

 
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no add'l info was available, add'l info has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1887530
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dennis100
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« Reply #46 on: January 27, 2014, 10:02:57 AM »

Model Number 37603
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# va02wws, implanted: (b)(6) 2012, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

 
Event Description
It was reported that the patient experienced a pull in her neck the day of the report and left sided neck pain. The patient stated it could be related to the implant. The patient had intermittent neck pain which worsened. The patient was to have an x-ray to visualize the skull, neck and chest to look for kinked wires or anything abnormal. It was further reported that the patient was at the emergency room on the day of the report and was having problems. The patient had head and shoulder pain and felt ¿loopy¿ and nauseated. The symptoms had been coming and going but the start date was unknown. There were no falls or traumas. It was stated that the patient¿s husband thought the er visit was related to the device because she had never felt this way before. Additional information noted the patient was scheduled to meet with her healthcare provider (hcp) on (b)(6) 2013. Additional information stated the patient could feel the wire in her neck. It was noted the patient had first noticed this a ¿little while¿ prior to follow-up. It was stated there were no known accidents or incidents related to this condition. Additional information reported the patient was not feeling her stimulation ¿like she should be¿ and that she was not ¿feeling it as well. ¿ it was noted this had occurred for the month prior to follow-up. The patient reported her hcp was about to put her in the hospital at the time of follow-up. No additional information was provided at that time. The patient was redirected to her hcp. A supplemental report will be filed if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3534208
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dennis100
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« Reply #47 on: January 28, 2014, 09:18:24 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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dennis100
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« Reply #48 on: January 28, 2014, 09:19:07 AM »

Model Number 7428
Device Problem No Known Device Problem
Event Date 11/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4). Analysis results were not available at the time of this report. A f/u report will be sent when analysis is completed.

 
Event Description
Received report, the pt felt there was something wrong with the ins battery because they were experiencing more pain in their shoulders and neck. She heard the battery only lasted for 5 years and her battery was more than 5 years old. The battery was checked regularly and it was at 2. 64v with 30-70% capacity used. The hospital did not feel anything was wrong with the device, but one doctor finally agreed to change it. The battery was checked 2 more times. On (b)(6) 2010, it was at 2. 64v and again on (b)(6) 2010, it was still 2. 64v. Impedances were not checked at this time, but it was noted that more than 5 yrs ago, there were some irregular impedances which resolved with time. Pt was reported as having no injury. The hospital does not think anything is wrong with the device, but is returning it to medtronic for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1920169
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dennis100
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« Reply #49 on: January 28, 2014, 09:20:18 AM »

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

 
Manufacturer Narrative
(b)(4) (no code): torticollis (yes). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time, no additional information was available, additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1913949
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« Reply #50 on: May 11, 2014, 06:27:08 PM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported that the lead up a patient¿s neck was ¿quite sore all the time¿ and was ¿swollen part of the time. ¿ it was noted that the patient was wondering if there was a problem with the wires or if he was allergic to it. It was reported that it started a couple of months prior to the report and it had been painful for three or four days prior to the report. The reporter stated that the patient¿s physician said that it ¿happened sometimes. ¿ it was reported that the patient had an appointment scheduled to see his physician on (b)(6) 2013. Additional information received reported that the patient is still having concerns with their device but has not sought further help. It was noted that the patient had an appointment on 2013 (b)(6). It was later reported that there was an infection. The patient had been treated for an infection at the lead wire sites in the neck. The patient was taking a second round of antibiotics and the areas that appeared to be infected had not seemed to be getting any better. It was noted that there were 2 sites and they were the entry points in the patient¿s neck where the lead wires had been inserted. Since the implant, the patient had had ¿scabbing¿ at those two spots and they had never completely healed. It was noted that on (b)(6) 2014, the sores had appeared to be ¿boiling up¿ and looked bad. The caller was concerned that it was the lead wires themselves that caused the infection. The healthcare professional was aware of the sites and was treating the patient with a second round of antibiotics. The patient had had pain in the neck area around the lead wires for over a year prior to (b)(6) 2014. Patient¿s friend or family member was unsure what the next step was for the patient¿s leads or if they would need to be removed. Patient had a follow-up appointment scheduled for (b)(6) 2014. It was noted that all wires were on the patient¿s right side. Patient was reprogrammed on (b)(6) 2014 and (b)(6) 2014. It was further noted that about one and a half months prior to (b)(6) 2014, the patient had a mole removed that was near the lead entry points and the day prior to that the surgeon removed one of the ¿scabbed areas¿ with a razor. On (b)(6) 2014, the ¿lower lead entry point¿ appeared ¿puffy and boil like. ¿ it was further noted that the patient could feel the wires in his head sticking out of his skull. The healthcare professional felt the patient¿s skull in that area but had not felt what the patient had described feeling.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3721023
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dennis100
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« Reply #51 on: May 11, 2014, 08:13:24 PM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant medical products: product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(4) 2008, product type: lead. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2008, product type: lead. (b)(4).
Event Description
It was reported that the physician¿s assistant (pa) called the reporter stating therapy impedance was high. The reporter did not have the settings or all of the impedance readings. The reporter stated that this may have been the first follow-up since implant and the patient was in for a suture check. The patient also complained of shocking down her jaw and leg that occurred every four to five minutes. The shocking would go away when the device was turned off. Palpation did not show anything and the ¿left was fine. ¿ the following day it was reported that the patient experienced shocking and a feeling of parasthesias in the left face, neck, tongue, cheek, and even in her leg that occurred every four to five minutes. It was also noted that during a clinician programmer programming session when the programmer head was pressed up against the implantable neurostimulator (ins) pocket she ¿felt a little something at the pocket. ¿ the patient was seen by the pa the day prior to the report and her impedances were checked. They looked to be within normal range, but it was noted that the clinician programmer indicated the therapy impedance was high. The reporter stopped by the clinic during the session and also got a high therapy impedance. They decreased the patient¿s voltage from 3 volts to 2. 8 volts and all of her shocking and parasthesias went away. The sensation that occurred when the programmer head touched the pocket site also went away. The patient had had good therapy since the most recent ins replacement and continued to get therapy after voltage was changed. They planned to keep an eye on the patient going forward for any changes. The patient was scheduled to be seen in (b)(6) 2014. Three days later it was reported that the patient still felt the shocking sensation, so the doctor was making arrangements to see her again the week of the report. Nine days later it was reported that the patient was to be seen again on (b)(6) 2014 for further investigation. The patient was tentatively scheduled for an extension revision. Additional information was requested, but was not available as of the date of this report.

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« Reply #52 on: May 12, 2014, 02:26:11 AM »

Model Number 37612
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported that the patient was having random shocking pain on and off through the whole body but mainly behind the ¿wire¿ in her neck about half an inch behind the wire. It was noted that this had been going for a couple of months prior to the date of this report. It was further noted that the last couple of weeks prior to the date of this report the shocking pain seemed to have gotten pretty bad. The patient had botox about a month prior to the date of this report which seemed to have helped the shocking pain. Impedance levels were tested at the end of (b)(6) 2014 when the patient had the botox and impedance levels were fine. It was noted that the patient never seemed to get better for very long. Patient was on their way to the emergency room because of the shocking pain at the time of this report. It was later reported that there was a shocking or jolting sensation. The patient had lead replacement surgery on (b)(6) 2014. Additional information was requested but had not been received as of the date of this report.

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« Reply #53 on: July 05, 2014, 12:13:13 AM »

Model Number 7426
Event Date 08/05/2009
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant products: product id 7426, serial# (b)(4), implanted: (b)(6) 2009, product type implantable neurostimulator; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type extension; product id 3387s-40, lot# v252498, implanted: (b)(6) 2009, product type lead; product id 3387s-40, lot# v274380, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type extension. (b)(4).
Event Description
It was reported that the patient¿s parkinson¿s had been progressing ¿since forever. ¿ the patient¿s progressing symptoms included walking stiffness, feeling immobilized, neck stiffness, and depression. The reporter stated that the patient had an x-ray ¿last week¿ to confirm the lead wires were too short. The reporter mentioned that shortly after implant a revision was done to ¿make the leads longer or move the implantable neurostimulator (ins) higher. ¿ since then the patient still felt the leads were too short and were tugging on the ins, pulling it higher on her chest. The patient¿s healthcare provider (hcp) told her to ¿just wait and the leads would get longer. ¿ the reporter stated that ¿it did not look right,¿ that two wires were visible, sticking out of the patient¿s neck and could be seen under her skin. No erosion was indicated. The reporter noted that the patient¿s symptoms were worse when the ¿wires stuck out, like the stimulation was causing something to happen. ¿ the reporter also mentioned that the patient had a mammogram ¿last year¿ and was worried that it crushed a corner of the ins. The corner ¿felt out of place. ¿ 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=3845773
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« Reply #54 on: July 05, 2014, 12:16:05 AM »

Model Number 7426
Event Type Injury Patient Outcome Required Intervention,Hospitalization Manufacturer Narrative
Concomitant medical products: product id 3387-28, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2014, product type: lead. (b)(4).
Event Description
It was reported that 18 months prior to report, the impedance values of the patient¿s #0 and #2 electrodes suddenly decreased. It was further reported that this ¿resulted in high-power stimulation and the patient presented with symptoms of internal capsule stimulation. ¿ it was stated the patient¿s physician considered the ¿possibility of a lead problem¿ and it was decided to replace the patient¿s leads on (b)(6) 2014. It was reported that following the replacement of the lead, the patient¿s ¿impedance values had not changed at all. ¿ it was stated ¿the problem was not attributable to the lead¿ and ¿the physician did not know what might be a possible cause. ¿ additional information stated that when stimulation was performed on (b)(6) 2013 there ¿were fluctuations in the electric current value due to fluctuations in impedance. ¿ it was reported that when impedances were checked on (b)(6) 2013 ¿there were no problems with the left electrode¿ and that the right electrode¿s #0 and #2 had ¿low¿ impedances. Impedance records indicate the ¿low¿ values for contacts #0 and #2 were 346 ohms and 479 ohms respectively. It was stated the patient¿s ¿neck was still in pain¿ and that it was ¿difficult to face right. ¿ it was reported that ¿tension in the right dominant sternocleidomastoid (scm) was the most noticeable¿ and that it was also noticeable in the patient¿s right trapezius muscle. It was noted the patient had ¿botulinus administered on (b)(6) 2013 and that ¿it was difficult to control the patient¿s symptoms in their neck region, so botulinus was used concurrently. ¿ it was reported that ¿dystonia was not triggered through stimulation in the left finger like it was in the past. ¿ it was stated the patient had been previously hospitalized at a neurological hospital in (b)(6) 2012. It was further reported that impedance testing performed on (b)(6) 2014 found ¿low¿ impedances on electrodes #0 and #2 of 259 ohms and 356 ohms respectively ¿ both measured at 2. 5 volts. It was again noted these impedances were ¿too low. ¿ while performing stimulation testing it was reported the patient experienced their left hand being ¿heavy. ¿ it was stated the patient could not fully extend their fourth or fifth fingers at times during the test. Eventually it was noted the patient could extend their fourth finger ¿if done consciously. ¿ it was additionally reported that a surgery was performed on (b)(6) 2014 ¿to shift the dbs (deep brain stimulation) electrode on both sides. ¿ it was stated this was performed because ¿there was a problem with the electrode placement position itself¿ and ¿there was a concern about whether the impedance was low due to the dbs electrode. ¿ it was further stated there ¿seemed like there was a problem with the dbs electrode itself (disconnection?). ¿ it was reported that after the surgery to shift the electrodes, the impedances in the right electrodes #0 and #2 were ¿still low. ¿ the ¿low¿ therapeutic impedance values when measured at 3 volts were found to be 269 ohms and 374 ohms for electrodes #0 and #2 respectively. It was stated that ¿when the electric current was applied¿ the patient complained of ¿tingling sensations in the implantable neurostimulator (ins) region. ¿ it was further stated the patient reported the ¿ins was painful¿ and the ¿ins was tingling. ¿ it was reported it was ¿slightly difficult to extend [their] left fingers¿ and ¿slightly difficulty to bend [their] right fingers¿ during a stimulation test. It was additionally reported that during the stimulation test the patient¿s right upper limb and lower left limb were ¿slightly heavy¿ and the right bottom half of the patient¿s body ¿felt tingly and fuzzy. ¿ it was stated the patient¿s shoulder also felt ¿strained. ¿ impedance testing performed on (b)(6) 2014 indicated the right electrodes #0 and #2 had impedances of 294 ohms and 432 ohms respectively. Impedance testing also indicated the right bipolar electrode pair 1-3 had an impedance value ¿>2000¿ ohms. It was noted that electrodes #0 and #2 ¿were both five years old. ¿ additional information reported ¿electrode replacement surgery was performed, however, the resistance value was low and did not change. ¿ it was stated there was ¿possibly a problem with the electrode and there was a problem with the indwelling position of the lead as well. ¿ it was noted that on (b)(6) 2014 a lead was ¿extracted¿ and would be collected at a later date for analysis. It was additionally noted that ¿since the low resistance continues even after changing the ins and lead, the cause of the low resistance could be from the extension part. ¿ it was noted the patient was admitted to the hospital for ¿recovery¿ following their lead replacement procedure. Additional information stated ¿stinging sensations persisted¿ after the lead replacement was completed. Additional information stated the patient ¿had not had effective therapy¿ and the ¿cause was not determined¿ as of 17 days after initial report. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3855294
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« Reply #55 on: August 11, 2014, 01:19:40 AM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Event Description
It was originally reported on (b)(6) 2012 that the patient had acute pain and when she moved her neck it was painful. There was also a tight feeling where the lead, extension, and implantable neurostimulator (ins) were located. The patient stated that one could see the ins move when she moved her head. The patient noted that this feeling began approximately two to three weeks post implant. The patient saw her manufacturer representative in (b)(6) 2012 to turn off her ins for eye surgery and discussed the issue with them and both of her doctors, but nothing was being done about it. Eight days later, it was reported that the patient had ¿restricted neck movement¿ and pulling of the ins at the ins site since implant. The patient also reported that ¿behind the battery pack, she felt a burning miserable pain, which was about a 5-6 on pain scale. ¿ the patient noted that the issues started three to four weeks post implant of the ins. The issues were at the ins location, the right upper chest, the lead-extension connection location, and the extension location. The patient¿s status was fair, but she was very frustrated with her healthcare provider (hcp) as she had been pushed off by the hcp. The patient was supposed to be getting a callback from the surgeon or nurse on the day of the report to discuss further options. The patient discussed an x-ray with the surgeon in (b)(6) , but was told that ¿x-rays would not allow them to see the extension. ¿ the patient mentioned that being unable to turn her head made it challenging to do things. About two weeks later, it was reported that the patient was still having concerns regarding her device or therapy, but was working with her doctor or manufacturer representative. About two months later, it was reported that the patient had an issue with scar tissue restricting the lead from her therapy to the battery pack. It pulled when the patient moved her head and pulled the battery pack, which was painful. The doctor stated that he could do surgery to release the scar tissue, but could not prevent it from happening again. A different doctor was willing to see the patient and try to release the scar tissue and felt he could do a procedure which may be able to prevent the scar tissue problem from happening again. The first doctor recommended astym therapy, which the patient did twice a week for seven weeks, but it was not effective and ¿sure did hurt. ¿ the patient noted that the therapy had been wonderful for her tremors which were about 99% corrected. The patient¿s legs shaking and head nodding were also gone. The patient mentioned that she had two surgeries, one on each side. The patient had the leads going into a larger battery, rather than two smaller ones. It felt as though the sides, corners, and edges felt kind of sharp, so it was noticeably uncomfortable. The patient suggested that if the ins could be designed with the type of contours as the remote, it would be smoother and probably more comfortable. The patient suggested that maybe she just had not had it in her body long enough to get used to it. About two weeks later, it was reported that the cause of the event was tightness of the extension cable with head turning. The event was attributed to the extension. No programming or intervention was performed. No hospitalization was required and the patient outcome was noted as no injury. Almost two years later it was reported that the patient¿s first doctor ¿kind of screwed things up when she had the implant in 2012. ¿ the patient stated that it took two surgeries to correct things. The patient did not know why, but from the time the battery pack was installed her head was so restricted that if she moved her head at all it was pulling that battery pack and she could feel it tearing tissue. The patient stated that she called her first doctor¿s office ¿day after day starting right after the surgery in (b)(6), but never got a call back. ¿ the only time the patient spoke with the first doctor was at the post-operative visit and ¿she was already a week in frustration, but she just had surgery so she did not know what should be right or wrong, but felt like her head should not be so restricted. ¿ in (b)(6) 2012, the patient saw a new doctor and the first thing he did was order x-rays. The doctor stated that the x-ray did not look good and replaced the extension that was nine inches longer because the other was too short.

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« Reply #56 on: September 06, 2014, 12:52:44 AM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Event Description
It was originally reported on (b)(6) 2013 that the patient was feeling really hot in the chest on the left side where the implant was located, and also in the head and back. It was stated that the patient also felt dizzy. This started two weeks prior to the report. It was stated that it could be her menopause, too. The patient also felt that stimulation was too strong and that it made her muscle tense up more than the previous implant. She started at 2. 50 v with this system, but in her previous system her range was 0-2. 50. About eleven months later it was reported that the patient¿s neck was hot and this started one year ago. The patient was told that her lead was fractured and she was scheduled for device removal on (b)(6) 2014. The patient wanted to know what she could do about the heat and noted that she got the remote, synched with the implantable neurostimulator (ins), and stimulation showed off. The patient had spoken with her healthcare provider (hcp) and the office, but they would not move up the surgery date and they did not have any direction on what she could do in the meantime. Additional information was requested, but was not available as of the date of this report.
Manufacturer Narrative
Concomitant products: product id 37642, serial # (b)(6), product type programmer, patient; product id 64002, lot # n390514, implanted: (b)(6) 2013, product type adapter; product id 3387-40, lot # j0519305v, implanted: (b)(6) 2005, product type lead; product id 748251, serial # (b)(6), implanted: (b)(6) 2005, product type extension; product id 3387-40, lot # j0519305v, implanted: (b)(6) 2005, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension. (b)(4).

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« Reply #57 on: October 12, 2014, 04:21:08 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported by the doctor that the patient may have a system malfunction as the left side of his body developed a tonic contraction that lasted 30 seconds when the right implantable neurostimulator (ins) was turned off. The patient was seen on (b)(6) 2014 by the doctor and manufacturer representative to have the system evaluated. The patient stated that he had minimal efficacy since (b)(6) 2013 and what little efficacy he did noticed had decreased recently. He was having more speech and tremor problems. Since that date the patient had noticed the tonic contraction on the left side of his face and neck at the moment the ins turned off. The contraction was intense for several seconds and he felt numbness in his tongue. The contraction faded away after ten to fifteen minutes. The configuration was changed multiple times and the contraction was less severe. The patient was not told when the ins was turned off in order to rule out the influence. It was discovered that if the settings were slowly decreased he felt increased parasthesias in his thumb and fingertips, but he did not have the face and arm tonic contraction. Impedances were taken in several positions and while palpating. The impedances were consistent throughout and within normal range. It was noted that the placement of the lead was ¿textbook¿ and there were no historical impedance values available. The patient had reprogramming once a month to address the efficacy issues. It was eventually decided that the patient would have his right ins and extension replaced on (b)(6) 2014. The surgery had not yet occurred, so the patient outcome was unavailable. Additional information will be requested after the reported surgical date and if additional information is received, a supplemental report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# va0a6sn, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3389s-40, lot# va0ab21, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. (b)(4).

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« Reply #58 on: October 13, 2014, 03:29:39 AM »

Model Number 37602
Event Date 08/06/2014
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient¿s implantable neurostimulator (ins) was changed the day prior to report and ¿the nurse who was doing the settings put the patient¿s settings too low. ¿ the patient was ¿complaining of having breathing difficulties, freezing, head fallen sideways, trouble walking,¿ and stiffness of her neck at the time of report. The patient had also reportedly ¿fallen from bed because of the freezing in her body. ¿ the patient was instructed to go to the emergency room at the time of report due to her ¿loss of therapeutic effect¿ following the ins replacement. Upon replacing the patient¿s devices, the patient had reported ¿feeling a little bit of tingling in her finger at a higher setting¿ so the nurse had lowered the patient¿s settings. Later however, when the patient recovered from anesthesia, ¿all of the parkinson¿s symptoms returned with a vengeance¿ on the morning of the report. Additional information has been requested. A supplemental report will be filed if additional information is received. Please see manufacturer report #3004209178-2014-16425 for information regarding the patient¿s other ins.

Manufacturer Narrative
Concomitant products: product id 37602, serial # (b)(4), implanted: (b)(6) 2014, product type implantable neurostimulator. (b)(4).

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« Reply #59 on: November 07, 2014, 10:45:04 PM »

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

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

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