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Author Topic: Deep brain stimulator - Neck  (Read 29193 times)
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dennis100
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« on: November 06, 2013, 01:36:17 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 04/29/2010
Event Type  Death   Patient Outcome  Death
Event Description

Literature: williams a, gill s, varma t, et al. Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced parkinson's disease (pd surg trial): a randomised, open-label trial. Lancet neurol jun 2010;9(6):581-591. Summary: this article discussed the results of a one-year f/u in an ongoing, randomized, open-label trial involving 13 centers in (b)(6) of 366 patients with parkinson's disease (pd) that was not controlled by medical therapy who were randomly assigned between (b)(6) 2000 and (b)(6) 2006 to immediate surgery (deep brain stimulation) and best medical therapy or best medical therapy alone. The subthalamic nucleus was the target in 174 out of 178 surgery patients, and 176 of the 178 procedures were bilateral. Patients in both groups received medical therapy, which could have included apomorphine, other dopamine agonists, monoamine oxidase type b inhibitors, cathechol-o-methyltransferase inhibitors, amanatadine, or other drugs used for pd. The primary data used was pt self-reported quality of life on the 39-item pd questionaire. Clinical assessments of functioning using the unified parkinson's disease rating scale in both on and off states and cognitive states using the dementia rating scale-ii also were performed. Changes between baseline and one year were compared. Serious and non-serious adverse events were also recorded. Serious adverse events were defined as those events that resulted in a prolonged stay in the hospital, hospital admission, were thought to be life-threatening, or resulted in death. Reportable event: all of the following events were designated "serious adverse events" as defined above: one pt died from hemorrhage during implantation surgery. Two patients experienced surgery-related hemorrhage. One pt had a hemorrhage five months after surgery. The hemorrhage was considered "probably not" treatment related. Sixteen pts developed surgery related infections. Five patients experienced post-operative confusion that was considered dbs-specific. Two patients experienced neck pain that was considered surgery related dbs-specific. Two patients experienced seizures that were considered surgery related, dbs-specific. One pt experienced deteriorating control of pd because the battery was switched off. There was no allegation that the device malfunctioned. One pt experienced psychosis that was considered surgery related, dbs-specific. One pt became unresponsive on the operating table. The authors believed this possibly to be related to levodopa withdrawal. One pt experienced visual neglect from edema that was considered surgery related, dbs-specific. Four patients experienced urinary retention that was considered general surgery related. Two patients experienced pulmonary embolism that was considered general surgery related. One pt experienced an anxiety attack that was considered general surgery related. One pt experienced post-operative hypotension. In one pt, there was difficulty removing the catheter after surgery. One pt experienced pyrexia that was considered general surgery related. Three patients experienced falls that were considered pd related and/or drug related. Two patients experienced constipation that was considered pd related and/or drug related. One pt experienced two episodes of constipation that was considered pd related and/or drug related. Eleven patients experienced worsening of pd symptoms or uncontrolled pd symptoms that were considered pd related and/or drug related. One pt experienced two episodes of worsening of pd symptoms or uncontrolled pd symptoms that were considered pd related and/or drug related.
 
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. It is also possible several events occurred in one pt. At this time, no add'l info was available, add'l info regarding the pt, event, interventions and outcome has been requested. Two patients experienced chest pain that was not categorized as surgery related or pd related or drug related. One pt experienced angina that was not categorized as surgery related or pd related or drug related. Three patients experienced pain that was not categorized as surgery related or pd related or drug related. Three patients experienced neuropsychiatric disturbance (including hallucinations or paranoia) that were considered pd related and/or drug related. One pt attempted suicide that was considered pd related and/or drug related. The pt previously had attempted suicide prior to trial entry. Two patients had unspecified pd drug related adverse events. Two patients experienced chest infections that were not categorized as surgery related or pd related or drug related. One pt collapsed, which was not categorized as surgery related or pd related or drug related. One pt experienced deep vein thrombosis more than 8 months after surgery that was not categorized as surgery related to pd related or drug related. One patient experienced pulmonary embolism more than 8 months after surgery that was not categorized as surgery related, pd related or drug related. One pt experienced a fainting episode that was not categorized as surgery related or pd related or drug related. One pt experienced vertigo that was not categorized as surgery related or pd related or drug related. Five patients experienced urinary problems that were not categorized as surgery related or pd or drug related.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2116650

« Last Edit: February 03, 2014, 02:41:44 AM by dennis100 » Logged
dennis100
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« Reply #1 on: November 06, 2013, 01:37:02 AM »

Model Number IPGNEURO
Device Problem Low impedance
Event Date 07/20/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the patient felt stimulation in the neck and head beginning about (b)(6) prior to report. It was noted that the lead-extension connection site was along the patient's neck. Therapy impedance measured 491 ohms (46ua). Low impedances (50 ohms) were reported. Specific impedance measurements were as follows: o&c 569 ohms, 1&c 965 ohms, 2&c 950 ohms, 3&c ohms, 0&1 850 ohms, 0&2 817 ohms, 0&3 50 ohms with 234 ua, 1&2 1077 ohms, 1&3 861 ohms, 2&3 828 ohms. The lead was replaced. The patient incurred no injury and was well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2230450

« Last Edit: February 03, 2014, 02:42:04 AM by dennis100 » Logged
dennis100
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« Reply #2 on: November 06, 2013, 07:26:08 AM »

Model Number IPGNEURO
Device Problems Circuit Failure; Disconnection
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b) (4).
 
Event Description

After implant an open circuit was discovered. The physician tried to troubleshoot all the connections. He observed that the extension needed to be advanced into the ins another 1-1. 5mm. The physician commented that several of his patients complained about tight feelings in the neck with the current extension design.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1626740
« Last Edit: February 03, 2014, 02:42:30 AM by dennis100 » Logged
dennis100
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« Reply #3 on: November 06, 2013, 11:43:06 AM »

Model Number IPGNEURO
Device Problem Device operates differently than expected
Event Date 11/09/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

The patient experienced decreased stimulation since the beginning of 2009. Implantable neurostimulator therapy amplitude was increased to 8 volts. The patient had muscle contractions around his head and neck. The extension was replaced. Afterward, impedances were good and stimulation worked well. There was no patient injury associated with the event.
 
Manufacturer Narrative

The extension was 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=1562570

« Last Edit: February 03, 2014, 02:43:04 AM by dennis100 » Logged
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« Reply #4 on: December 06, 2013, 12:33:13 PM »

Model Number 7426
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Product id 3387s-40, lot #v399857, implanted: 2010 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 3387s-40 lot# v415236, implanted: 2010 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 7426, serial# (b)(4), implanted: 2010 (b)(6), explanted: 2012 (b)(6); product type implantable neurostimulator product id 3387s-40 lot# v399857, implanted: 2010 (b)(6); product type lead product id 3387s-40, lot #v415236, implanted: 2010 (b)(6); product type lead product id 7426, serial# (b)(4), implanted: 2010 (b)(6), explanted: 2012 (b)(6); product type implantable neurostimulator. (b)(4).

 
Event Description
It was reported the patients deep brain stimulation was working for her until she had an adjustment done sometime in 2010, and it "messed everything up". It was reported, the adjustment caused her "neck to pull back and broke the lead". The lead was replaced (b)(6) 2012.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3456426
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dennis100
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« Reply #5 on: December 06, 2013, 12:33:48 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Product id: 3387s-40, lot# v020895, implanted: (b)(6) 2007, product type: lead. Product id: 3387s-40, lot# v020895, implanted: (b)(6) 2007, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 7436, serial# (b)(4), implanted: (b)(6) 2007, product type: programmer. Patient product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. (b)(4). Analysis of the implantable neurostimulator (ins) found the battery was not in new condition. Foreign material was seen in connector ports #6 and #7. Ins output was tested at the distal end of a known good extension. Good, stable output was observed on each electrode pair on an oscilloscope, across a 510 ohm load, connected to the distal end of the extension. Power on reset had occurred prior to analysis. Punchout holes in setscrew grommets #6 and #7. There was foreign material (suspected body fluid) in the setscrew port under the grommets. The device was used for an off label indication. The therapy the device was used for was epilepsy.

 
Event Description
It was reported the patient experienced neurostimulator pocket discomfort and vibration in the neck. It was noted the event date of the discomfort was (b)(6) 2010 and (b)(6) 2010 for the vibration in the neck due to the extension tract. It was also noted the patient¿s ¿dbs was not working. ¿ the patient¿s neurostimulator was replaced on (b)(6) 2011 due to battery depletion and it was reported the patient recovered without sequelae after the neurostimulator was replaced. The outcome was resolved without sequelae with a resolution date of (b)(6) 2013 and symptoms were alleviated when wearing a sports bra.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3451980
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« Reply #6 on: December 07, 2013, 06:21:47 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3476855
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« Reply #7 on: December 07, 2013, 06:22:33 AM »

Model Number 37602
Event Date 09/13/2013
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id 37642, serial # unknown, implanted: (b)(6) 2013, product type programmer, patient; product id 37602, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 3387s-40, lot # v094755, implanted: (b)(6) 2008, product type lead; product id 3387s-40, lot # v050681, implanted: (b)(6) 2007, product type lead. (b)(4).

 
Event Description
It was reported that patient experienced loss of therapeutic effect post implant. It was added that the company representative had set the amplitude at 2/3v. It was reported that patient was having ¿internal shaking; no one could see it and felt nauseated. ¿ it was reported that four days after the day of this report the amplitude was changed back to old setting, 4. 1/4. 3v and patient felt fine for couple of hours. It was indicated that patient felt fatigue and her voice felt weak. It was noted that patient continued to have freezing and stiffness in the neck. It was added that there was no change in medication and anesthesia informed could be due to post-surgical. Additional information reported that the patient did not have access to adjust stimulation. Follow up from the health care provider reported right side impedances were high when they were checked on (b)(6) 2013. The patient was not getting effective stimulation. All impedances using contact zero were greater than 22,000 ohms. It was noted this was the patient¿s therapeutic contact. They attempted to reprogram using contact one. Programming was unsuccessful to the patient¿s satisfaction. The physician explored the stimulator site on (b)(6) 2013 and found a loose connection. Impedance check was normal and patient resumed therapeutic settings.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3462365
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« Reply #8 on: December 07, 2013, 06:23:34 AM »

Model Number 37601
Event Date 10/03/2013
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
Concomitant medical products: product id 3708660, serial# (b)(4), product type extension product id 3708660, serial# (b)(4). Product type extension. (b)(4).

 
Event Description
It was reported that there was a "misdirection of the electrode around the implantable neurostimulator (ins)". It was stated that this "necessitated medical or surgical intervention". X-rays had been taken that revealed a "dislocation of electrode" on (b)(6)-2013. The signs or symptoms were reported to be "pressure, pain above the ins location when moving the right arm, and pain in the head was growing". It was noted that there was no inflammation. Additional information received reported that there was "stimulator dislocation, loop of extension cable". It was not clear what the problem was. It was stated that this was "part of ongoing, but reduced complaint could still resolve as postoperative pain". That was also not clear. It was stated that this was "ongoing with no further action needed". It was reported that the device was surgically revised on (b)(6)-2013. It was noted that the stimulator and the extension were revised. X-rays were taken that revealed "loop of cable". It was not clear what this meant. It was stated that this event was possibly related to the implant procedure and it was related to the device or therapy. Signs or symptoms were reported as "pain in the stimulator and extension cable right neck". It was stated that this event resulted in "in-patient hospitalization". Additional information received reported that the extension migrated or dislodged.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3447275
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dennis100
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« Reply #9 on: December 07, 2013, 06:24:27 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that on the week prior to the report, the impedances were a little high. C-0 was 5000 but none of the other contacts were over 5000. It was noted that the extensions were tight in the neck area so they opted to reposition the battery and replace the extensions. It was noted that it was done during the case on the day of the report, however intraoperative, they had worse high impedances. The reporter stated they had disconnected the extension/lead as well as the lead/extension basically 3 times and reconnected multiple times without resolving. It was noted that the bad impedances were on the left side and the right side was a little high, but that was like that prior to the day of the report. It was noted there were 3000s to 4000s. It was noted that left side impedances were c-3 at 26377, 0-3 38000, 1-3 28000, and 2-3 25000. The reporter noted they had not tested right onto the lead. It was noted there was no adaptor in the case. It was further reported that the extensions were exchanged to relieve the tightness. Additional information has been requested but was not available as of the date of this report.

 
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3447350
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« Reply #10 on: December 30, 2013, 06:43:33 AM »

Model Number 7428
Device Problem Explanted
Event Type  Other   Patient Outcome  Other
Event Description
Hcp reported patient presented with signs of an infection of the device pocket. These include fever, redness, swelling, and neck pain. Cultures were not obtained. The patient was treated with both iv and oral antibiotics. Hcp reported patient's infection is now resolved.

 
Event Description
Hcp reported patient presented with signs of infection in may 2005. Symptoms included redness, swelling, fever, drainage and stiff neck. The device was removed and a picc line was inserted. The device was explanted but not returned to the manufacturer for analysis.

 
Manufacturer Narrative
B5: hcp reported patient presented with signs of an infection of the device pocket. These include fever, redness, swelling, and neck pain. Cultures were not obtained. The patient was treated with both iv and oral antibiotics. Hcp reported patient's infection is now resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=616961
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« Reply #11 on: January 02, 2014, 02:17:18 AM »

Model Number 7482
Device Problem Explanted
Event Date 10/18/2006
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
Hcp reports via va dbs clinical study report that the patient was admitted to the neurosurgery service for suspected infection of draining post-auricular dbs site. The wound culture was positive for methicillin-sensitive staph aureus which the paitent received via iv therapy. The remaining device system on the right side and the generator were explanted completely in 2006. The patient remained afebrille and was discharged next day with medication stabilized treatment of parkinson' disease and with the plan of 7 days full course of vancomycin followed by 7 days of oral keflex and home physical therapy. Later that night, the paitent had fever of 101. 4 and was readmitted for suspected meningitis. Ceftazidme was initally added to vancomycin regiment and then changed to cefepine based on cultures. Worsening of pc motoric symptoms attributed to missed anti-pd medicastion doses. Neck stiffness on exam. Patient remained afebrile during the hospital stay. A ct of the brain indicated no intracranial bleed; left parietal scalp swelling was new since 1/06 scan. Meningitis was reuled out and fever with accompanying fatigue, lethargy, was attributed to ingoing infectious process. The patient was discharged in stable condition the day after explantation with home antibiotic therapy and physical therapy. The device was returned to the manufacturer for analysis.

 
Manufacturer Narrative
Preliminary device analysis was not available on the date of this report. A follow up report will be sent when device analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=785681
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« Reply #12 on: January 02, 2014, 02:18:17 AM »

Model Number 7426
Device Problem Explanted
Event Date 10/13/2006
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Information received from hcp with product returned for analysis shows the patient presented in 2006 with signs of infection including redness and swelling over the left dbs generator; erythema and swelling in the left cervical region, and soreness in the neck and chest. The patient was afebrile at home, although was 99. 9 at the clinic. The patient was admitted to the hospital in 2006 for removal of the left deep brain stimulator battery as well as the wire (extension) and lead. Hcp reports dbs placement in two parts; second part in 2006. Operative notes show that antibiotics were held until intraoperative cultures were obtained. Intraoperative surgical inspection was also made of the left mastoid where the wire passed and gross pus was found resulting in total system removal with products returned to the manufacturer for analysis. The patient was started on vancomycin and cefepime while intraoperative cultures and sensitivites were pending. The cultures grew out coagulase-positive staph aureus that was oxacilin sensitive. Patient then began a course of oxacillin 12 grams by iv continuous infusion while administration of vancomycin and cefepime were stopped. Hcp reports the patient has started to display increasing parkinsonian tremor and disability following product explant. The patient is reported as able to ambulate, but has difficulty monitoring his adls because of the increase in symptoms. The patient was discharged in 2006 in stable condition with home antibiotics oxacillin 12 grams by iv continuous infusion for six weeks when the patient is to return for follow-up. The hcp stated that future dbs placement may be redone in this patient.

 
Manufacturer Narrative
Final device analysis results reveal - no anomaly found - normal device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=788996
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« Reply #13 on: January 02, 2014, 02:19:32 AM »

Model Number 3387
Device Problem Explanted
Event Date 10/18/2006
Event Type  Other   Patient Outcome  Hospitalization,Other
Event Description
Hcp reports via clinical study report that the patient was admitted to the neurosurgery service for suspected infection of draining post-auricular dbs site. The wound culture was positive for methicillin-sensitive staph aureus which the patient received via iv therapy. The remaining device system on the right side and the generator were explanted completely the next day. The patient remained afebrille and was discharged the next day with medication stabilized treatment of parkinson's disease and with the plan of 7 day full course of vancomycin followed by 7 days of oral keflex and home physical therapy. Later that night the patient had a fever of 101. 4 and was readmitted for suspected meningitis. Ceftazidime was initally added to vancomycin regimen and then changed to cefepine based on cultures. Worsening of pc motoric symptoms attributed to missed anti-pd medication doses. Neck stiffness on exam. Patient remained afebrile during the hospital stay. A ct of the brain indicated no inracranial bleed; left parietal scalp swelling was new since early 2006 scan. Meningitis was ruled out and fever with accompanying fatigue, lethargy, was attributed to ongoing infectious process. The patient was discharged 4 days later with home antibiotic therapy and physical therapy. The device was returned to the manufacturer for analysis. Refer to mdr # 2182207200601983.

 
Manufacturer Narrative
Final device analysis results revealed no significant anomalies. The device was cut, but the manufacturer suspects explant damage.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=798857
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« Reply #14 on: January 02, 2014, 02:21:17 AM »

Model Number 7428
Device Problem Explanted
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Hcp reports taking the pt to the operating room for re-implantation of an ins system that had been removed by another surgeon in 2006. The date of the attempted re-implant procedure was not reported. Upon re-opening the previous cranial incision, pus was noted at the electrode site and cultures were taken. The hcp reports the causative organism is unk. Perioperative antibiotics were administered and the pt did not have meningitis. Physician indicated iv antibiotics were administered and the infection has reportedly resolved. Risk factors listed for the pt included diabetes and the pt had required multiple revisions of the extension device, due to discomfort in the neck at the extension site. No report received by the mfr at this time of system re-implantation. The ins system removed in 2006 has not been returned to the mfr for evaluation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=780020
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« Reply #15 on: January 02, 2014, 02:22:14 AM »

Model Number 7426
Device Problem Explanted
Event Type  Other   Patient Outcome  Other,Required Intervention
Event Description
Manufacturer representative reported the device system was explanted due to infection. Signs of infection were noted on the patient's neck which included suture line dehiscence. The patient was treated with antibiotics and a partial explant of the device system. Cultures were obtained after administration of the antibiotics, but unable to identify the type of organism. The patient recovered and a new device system was implanted. The device was explanted, but not returned to the manufacturer for analysis. A follow up report will be sent if additional information is received. Refer to mdr#3004209178200601478.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=757480
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« Reply #16 on: January 02, 2014, 02:24:42 AM »

Model Number 3387
Device Problems Failure to capture; Explanted
Event Date 06/14/2006
Event Type  Other   Patient Outcome  Death,Other
Manufacturer Narrative
Preliminary device analysis was not available at the time of this report. A follow up report will be sent when device analysis is complete.

 
Event Description
Clinical study reported presented with dbs wound erosion at the lead site. The clinical staff was notified by the patient's dental office staff of non healing head wound. The pt presented with wounds showing blanched color, peripheral redness and eschar formation of the right surgical site. The pt was reportedly on the following medications at the time of the event: amantadine, sinemet, entacapone, pramipexole, docusate, mirtazapine, clonazepam. Patient will be admitted to operating room for a plastic surgery consult. The surgeon does not believe the wound is infected. A follow up report will be sent when additional information is received. On 8/2/06 new information received from clinical study indicates patient admitted to neurosurgery service in 2006, for removal of right lead and navigus cap the next day. The patient remained afebrile, pain free with no new neurological or other acute changes. Scalp wound showed dried exudates and epithelial colonizing without drainage. The lead and cap were removed without complications. Left system left intact and functioning. Pd medications readjusted for increased neck/head dyskinesias with resolution within 24 hours. Cultures were obtained resulting in few pseudomonas aeruginosa and few gram positive cocci in clusters. Infectious disease was consulted and it was determined the pt would be treated with antibiotic therapy for at least 3 weeks. At 26 days post antibiotic therapy the pt was still afebrile with several episodes of irritability mainly during night hours. These were treated by increasing quietiapine. They were situation-related and due to side effects of medications or other medical conditions. The following month, the pt had an elevated wbc of 14,000 but was still afebrile and pain free. An mri and ct showed no residual hardware on the right side of the brain, left dbs system intact, and no brain abscess. Blood and urine cultures pending. Wound healing as expected with eschar, no drainage, redness, swelling or inflammation. Patient's spontaneity seems near baseline. The device was returned to the manufacturer for analysis.

 
Manufacturer Narrative
Evaluation summary: no anomalies found; proximal segment returned. No anomalies found. Specifically, sensing performance was tested extensively. In all cases, there was correct response from the device. Capture management data and lead impedance trend data showed no anomalies. The pacemaker and leads were returned for analysis after the patient's death. Both lead connector ends were still attached to the device. The physician questions if there was ventricular capture during ventricular pacing. The cause of death was requested but not received. Actual device involved in incident was evaluated. Mechanical tests performed. Electrical tests performed. Visual examination: device performed according to specifications. No conclusion can be drawn. Capture, failure to.

 
Event Description
The pacemaker and leads were returned for analysis after the patient's death. Both lead connector ends were still attached to the device. The physician questions if there was ventricular capture during ventricular pacing. The cause of death was requested, but not received.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=748992
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« Reply #17 on: January 02, 2014, 02:26:18 AM »

Model Number 7426
Device Problems Device remains activated; Device remains implanted
Event Type  Other   Patient Outcome  Other
Event Description
Hcp reports patient presented in 2006 with complaints of slurred speech neck and knee aches, and an inability to walk. The hcp saw the patient in clinic and performed troubleshooting for these events. The patient is medicated and has severe tremor in the left hand with moderate to severe tremor in the right hand. Speech is mildly slurred. During troubleshooting of the ipg was determined that the patient is experiencing neurodegenerative difficulty accounting for the unsteady gait a walker was recommended. The aching neck and knees are likely related to underlying arthritis and not related to the tremor. The slurred speech may be related to the tremor and improved with lower settings of the ipg, however, with lower settings the tremor worsened. The device remains implanted. The patient will see the hcp for follow up as needed. A follow up report will be sent if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=682007
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« Reply #18 on: January 03, 2014, 06:51:44 PM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=813545
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« Reply #19 on: January 14, 2014, 11:32:07 AM »

Model Number 7428
Device Problems Device remains implanted; Other (for use when an appropriate device code cannot be identified)
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
For revision surgery, not otherwise specified.

 
Event Description
The pt had extensive scarring in her neck area. When she turned her head, the extensions pulled on her deep brain stimulator and the pt experienced pain and 'overdose/underdose with her parkinson medication'. The pt had 3 surgeries to revise the lead-extension and remove the scar tissue. Aside from the scarring, it was reported that the deep brain stimulator therapy was working fine for the pt. A f/u report will be submitted if add'l info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1180200
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« Reply #20 on: January 14, 2014, 01:00:04 PM »

Model Number 7426
Device Problems Device remains implanted; Unit inactivated
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported, following implant, the patient experienced a lack of effect, acute pain in the face, and nausea. The patient had the ipg devices on for one day with good results. Following the first programming the patient then began experiencing the pain in the face and neck (also described as a painful tingling sensation on the face (cheek, nose and eye areas). The patient also experienced sensitivity to light and noise, a pulling sensation on her neck, and pain from the wire in her neck and the ipg in her chest. Reportedly, the worst symptom was the severe nausea. When the device was turned on, the nausea built up over time. The patient experienced dry-heaving and became dehydrated due to not eating or drinking. The patient was hospitalized for a few days (date unknown) to be evaluated for infection. The patient did not have an infection. The patient was prescribed steroids which did help some. The patient had her device turned off due to the return of symptoms when turned on. See mfr report #3004209178200804484. Additional information has been requested, but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1083478
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« Reply #21 on: January 16, 2014, 02:46:02 PM »

Model Number 7426
Device Problems High impedance; Lead(s), breakage of
Event Date 10/01/2008
Event Type  Malfunction 
Event Description
It was reported the pt was experiencing a loss of therapeutic effect starting about three weeks prior. Impedances were tested and were >2000 ohms on all of the unipolar pairs. There was no recent fall or trauma. Additional information received indicated the pt had reported falling back, but had not had any falls since then. The pt had reported feeling a "popping" type pain in her neck approximately one month ago. X-rays were taken of the lead/extension connection. A fracture in the lead was observed. The pt was referred to a neurosurgeon and was scheduled for a lead revision in 2008. At the time of this report, pt outcome and revision status were unk.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1249852
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« Reply #22 on: January 16, 2014, 02:48:06 PM »

Model Number 7428
Device Problems Replace; Implant, reprogramming of; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 04/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt was scanned with a security wand at an airport. His deep brain stimulator was 'zapped'. The pt immediately became dizzy, felt sick to his stomach, and fell to his knees. Two hours later, he had recovered and flew home. Several days later, the dystonia muscle spasms treated by the device gradually returned. Two months later, the deep brain stimulator was interrogated. The tests showed that the stimulator, battery, and electrodes were fine. There was no power on reset reading or out-of-range impedances. The pt's health became worse. He was unable to go for long walks, had difficulty sleeping and eating. The neck muscle spasms were periodically getting worse. The pt increased the device output with his pt programmer but became worse afterward. There were no symptoms changes if the deep brain stimulator was on or off. The hcp tested the implantable system again several months later. The diagnostic tests showed that the device was working correctly. Two months later, the pt 'could barely function'. The hcp turned the device off and the pt felt better for a couple of days. While the device off, the dystonia symptoms were not as severe as they were prior to deep brain stimulation. Head and neck x-rays taken one month later showed that no wires were broken and that the connections were intact. The pt was having difficulty walking or doing any other activities. About 4 months later (one year after the airport incident), the deep brain stimulator was replaced. The pt felt much better afterward. 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=1248090
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« Reply #23 on: January 17, 2014, 07:48:00 PM »

Model Number 7428
Device Problems Premature discharge of battery; Replace; Inappropriate shock
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the ipg light on the programmer was blinking. The patient experienced pain in the neck area and shocking on the neck that extended into the jaw. Upon interrogation it was discovered that the ipg was at end of life. The ipg, and possibly the extension, was replaced. The outcome of the surgery is unknown. The patient has since expired from unrelated causes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1313758
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« Reply #24 on: January 17, 2014, 07:48:35 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Type  Malfunction 
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
It was reported the pt was being programmed for the first time; programing went well on the left side. When programming on the right side at 1 volt, the pt experienced painful tonic contractions of the neck. When reprogramming on the left side the physician was getting that effect also. The manufacturer representative suspected a fluid leak on the right side and may need to surgically address the problem.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1354648
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« Reply #25 on: January 17, 2014, 07:49:31 PM »

Model Number 7428
Device Problem Electro-magnetic interference (EMI)
Event Type  Malfunction 
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
It was reported the patient experienced a loss of therapeutic effect following exposure to ultrasonic treatment at the dentist. The symptoms were at the neck and arms. The patient was at home and the status was reportedly good. The indication lights were reviewed with the patient and it was determined the stim was turned off. The manufacturer technical agent had the patient turn their stim on and reviewed patient on / off options until the stimulator could be checked by the physician or manufacturer representative.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1354652
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« Reply #26 on: January 17, 2014, 11:25:37 PM »

Model Number 7426
Device Problems Lead(s), fracture of; Replace
Event Date 01/01/2007
Event Type  Injury 
Manufacturer Narrative
 
Event Description
The hcp reported the pt had a moderate response to deep brain stimulation therapy. The lead fractured due to dystonia of the neck. The lead was replaced. 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=1341892
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« Reply #27 on: January 17, 2014, 11:45:01 PM »

Model Number 7426
Device Problem Component(s), broken
Event Date 02/01/2009
Event Type  Malfunction 
Event Description
It was reported the patient had a "wire broken" in their neck. It was confirmed by the hcp. No symptoms or outcome were reported. 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=1341866
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« Reply #28 on: January 18, 2014, 12:14:29 AM »

Model Number 7426
Device Problems Replace; Inappropriate shock
Event Date 01/02/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
The stimulator was 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.

 
Event Description
It was reported that the pt experienced intermittent shocking at the neck. The stimulator was replaced. It was felt that there was possibly a broken lead, but the physician requested that the batter be checked for defects. The pt recovered with sequela, the sequela was not specified.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1329176
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« Reply #29 on: January 18, 2014, 12:15:44 AM »

Model Number 7426
Device Problem Device remains implanted
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the pt experienced acute pain at lead site in the neck and swelling at their brow line following a "blow" to the head. The pt also reported a lot tension where the leads are placed, but the symptom relief was "just fine though". 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=1325838
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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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3736838
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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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3764000
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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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3955904
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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).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3973603
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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).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4062858
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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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« Reply #60 on: January 10, 2015, 05:35:37 AM »

Model Number 37603
Event Date 11/19/2014
Event Type Injury
Event Description
It was reported the patient was in the hospital since (b)(4) 2014 with a headache and sharp pains in their head and neck. The patient was not sure if it was related to their device or therapy. When the patient was in the shower and washing their hair, they hit a really tender spot when they were scrubbing their scalp. The patient felt the tenderness ¿three fingers¿ from the tip of their ear. The patient had called their healthcare professional (hcp) and they stated that where the patient felt the pain was where the connector was implanted. 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: 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3389s-40, lot# va00cfp, 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. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4318262
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« Reply #61 on: January 10, 2015, 08:29:43 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 8840, serial# unknown; product type programmer, physician product id neu_unknown_lead, lot# unknown; product type lead product id neu_unknown_ext, serial# unknown; product type extension product id neu_unknown_prog, serial# unknown; product type programmer, physician. (b)(4).

Event Description
It was reported, the patient had a loss of efficacy which was unrelated to the stimulation therapy. They arrived at the emergency room due to the return of tremor. It was after a programming session that had occurred earlier the day prior to report. Their symptoms were similar to when the implantable neurostimulator (ins) was turned off and they also had a tongue sensation of ¿being pulled backward. ¿ the tremor started immediately after the programming session with their managing physician. It was noted they were able to change the patient¿s settings back to the settings they had in 2013. There was an immediate improvement after the rate was changed. However, the patient still had a tremor. The patient hadn¿t had any medication recently which they thought could be another cause for some tremor. Additional information reported the ins battery voltage was at 2. 73v and the stimulation was on. The patient had head pain, neck tightness, and left side tremor return to ¿pre-device implant. ¿ two weeks prior to report, the patient had a re-adjustment programmed for tightness of his tongue and left side tremor and the settings were reprogrammed back to 2013. The left side voltage was changed from 3. 5v to 3. 4v and the right side from 4. 3v to 4. 1v. The patient felt a little improvement with his tongue tightness. There was no falls or trauma and no x-ray was performed. Additional information received reported there was not a 50% or greater symptom reduction and the cause of the event was not determined. While reprogramming was done, the patient had severe parkinson¿s symptoms of tremor, bradykinesia, and they couldn¿t talk on 2014 (b)(6). The loss of therapeutic effect and the loss of stimulation were sudden. The patient was admitted to the medical center on 2014 (b)(6) and was discharged on 2014 (b)(6). The patient died 7 days after being discharged and it was unknown if the death was device related.

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« Reply #62 on: March 07, 2015, 03:52:46 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient had their deep brain stimulator installed in 2012 and after discovering an exposed wire had the present unit installed on (b)(6) 2013. The patient¿s neck had been bothering him for a couple of months so the healthcare professional had checked it and discovered the wire was exposed. The exposed wire was discovered 8 months after implant. A replacement was done on (b)(6) 2013. They had to rewire everything and the healthcare professional was playing it safe because they were afraid there might be an infection. No infection was reported that was just the reasoning for doing everything except the leads. The patient¿s last visit to the healthcare professional was on (b)(6) 2013 and they had not followed up with the patient since the event. The patient had not had concerns with their device or therapy.

Manufacturer Narrative
Concomitant medical products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension; product id 3389s-40, lot# va01lp5, implanted: (b)(6) 2012, product type: lead; product id 3389s-40, lot# va01lp5, implanted: (b)(6) 2012, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4526333
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« Reply #63 on: April 19, 2015, 02:31:50 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that six months prior to this report the patient had a revision surgery to correct a ¿bowstring cord¿ problem in their neck. The implantable neurostimulator (ins) was initially implanted in the patient¿s chest and the revision was done to relocate the ins to the abdomen and add two extensions. For the past two months the problem had reoccurred and appeared to be worse than before. The patient had a loss of therapeutic effect, their therapy was in decline, and they were not getting any therapy benefit. At the time of this report the ins was on and the patient had not had any falls or trauma. The wires in the patient¿s neck were pulling and tugging again and they had become very tight. The patient stated it felt like the wire shifted and was pulling in the same area of the neck again. The patient had pain in their shoulder, chest, and neck especially after waking in the morning. The patient¿s pain and discomfort was moderate, but it was increasing on the side where the wire was running to the ins. The patient had been stretching their neck and that seemed to help take the strain off of the cord a little, but it was very painful to do it. The patient stated they had no idea if they were damaging the cord, units, or implants while stretching their neck. The patient had noticed indentations in their head and a bulge where one of the caps and wires was coming loose from the skull. The patient noticed they had swelling in their chest where the old ins and there was a bunching of wire in their abdomen by the ins. The patient had lost 10-15 pounds and they stated that may account for the noticeable signs in their head and stomach. Overall the ins was doing its job and functioned well and the patient felt the benefits outweighed the negatives. The patient¿s healthcare professional (hcp) did not see anything concerning and they thought the scarring around the extension was contributing to the discomfort. The patient¿s main concern was that if the wire continued to stretch, would it cause problems with the vein or artery that crossed their neck or would it pull on the leads in their brain. Almost two weeks later, the patient reported that their ins was not working correctly and there appeared to be a partial or total failure. The patient programmer was not picking up anything and the recharger was sporadic at picking up a signal. The patient was not sure if this was related to the extreme pulling in their neck or the bunching of wires in their abdomen near the ins. The patient was not feeling as much of the benefits and they were concerned that a wire might be loose and the programmer was inoperable. The patient was not able to turn the ins off since the programmer was not recognizing or reading the ins and it did not show any signs of an ins being present. The recharger had been able to connect to the ins just fine at times and had shown the ins was charging and functioning. The patient knew the ins was on as they were feeling some benefit. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, the event will be updated.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0gh58, implanted: (b)(6) 2014, product type: lead. Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014,product type: extension. Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4596445
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« Reply #64 on: April 19, 2015, 02:32:36 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the lead wire was rigid and it caused the patient¿s neck to be sore and stiff. There was pain in the neck at the extension location. It had been progressively getting worse since (b)(6) 2014 when the patient had gotten the implant. The patient¿s extensions were too tight. There was a lead/extension issue, it was too tight from the lead connection down to the clavicle. No action was required as a result of the event. In (b)(6) 2015 the healthcare professional had done a revision, they had gone in to pull the lead wire up and they had pulled some of the extension wires up in the neck to see if that would loosen the wires to give the patient more slack or loosen the wires, but that had not worked and the patient had a bundle of lead wire protruding under the skin above the clavicle. The patient had a buckled wire around the clavicle. The patient was very thin so he scared easily. The patient had stated that the design for a lead that would not cause scar tissue should be a ¿requirement. ¿ the healthcare professional had told the patient that because he was very thin and had little subcutaneous fat the wires had not ¿skude¿ under the skin as well. The healthcare professional also told the patient that the manufacturer needed to coat the extension with nano technology in order to fix the problem. The current extension wire formed scarring which lead to pulling and pain in the neck. Patients with a lot of fat had not experienced the issue but others do. This was becoming a common problem. The cause of the event was determine and was device related. The healthcare professional thought the coating applied to the wire, all of the wires got scarring then tended to cause pulling unless the patient had a lot of fat which acted as a lubricant. The patient had not recovered, symptoms/issue was ongoing. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received, a supplemental report will be submitted.

Manufacturer Narrative
Concomitant medical products: product id: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3387s-40, lot# va0hyjm, implanted: (b)(6) 2014, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4613200
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« Reply #65 on: May 09, 2015, 02:18:27 AM »

Model Number 37601
Event Date 06/24/2013
Event Type Injury
Event Description
It was reported that the patient experienced redness at the left frontal incision without ¿drain. ¿ corrective action included medication added, discontinued or dose change. The medication was bactrim. The event was reported as resolved. The patient also experienced neck discomfort due to pulling of the extension. Corrective action was noted as ¿other¿ and the event was not resolved.

Manufacturer Narrative
Concomitant products: product id: 3387, lot# unknown, product type: lead. Product id: 3387, lot# unknown, product type: lead. Product id: neu_unknown_ext, lot# serial# unknown, product type: extension. Product id: neu_unknown_ext, lot# serial# unknown, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4657287
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« Reply #66 on: May 09, 2015, 02:19:19 AM »

Model Number 37612
Event Date 03/25/2015
Event Type Injury
Event Description
It was reported that the patient¿s neurologist called the manufacturer representative (rep) and asked which x-rays would provide the best image of the implantable neurostimulator (ins), extensions, and leads. The patient self-admitted to the emergency room (er) the morning of the report; he had pain on the right side of the neck and a return of symptoms, including speech degradation and a change in gait. It was considered a sudden loss of stimulation and therapeutic effect. The ins was checked by the neurologist using a clinician programmer and it appeared to be on without any problems. The patient was hospitalized due to the event and was referred back to the original implanting physician for evaluation. No surgical interventions or patient outcome were reported, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant products: product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37651, serial # (b)(4), product type recharger; product id 64002, lot # n248030, implanted: (b)(6) 2010, product type adapter; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v050963, implanted: (b)(6) 2007, product type lead; product id 3389s-40, lot # v050963, implanted: (b)(6) 2007, product type lead. (b)(4).

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« Reply #67 on: June 08, 2015, 06:05:30 AM »

Model Number 37601
Event Date 04/05/2015
Event Type Injury
Event Description
Additional information received reported that the patient experienced an intracranial infection in the right frontal lobe.

Manufacturer Narrative

Event Description
It was reported that there was intracranial infection. The patient presented to the er with altered mental status, severe head and neck pain, and feeling like his insides were melting. The patient experienced in-patient hospitalization and an emergency room visit. Other surgical intervention was conducted including complete removal of bilateral electrode systems and generator. Perioperative antibiotics were administered specifically kefzol. The patient did not have meningitis. An organism culture showed staphylococcus aureus from the wound. Medication were administered specifically iv vancomycin and iv nafcillin on (b)(6) 2015. The outcome was noted as resolved without sequelae.

Manufacturer Narrative
Concomitant medical products: product id 3387s-40, lot# va0qxld, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead; product id 3387s-40, lot# va0nplb, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension. (b)(4).

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« Reply #68 on: June 08, 2015, 06:06:18 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported the patient had chest pain, a loss of effect, and a lack of symptom control since the replacement of their implantable neurostimulators (ins). The patient had been having slurred speech and issues with controlling their tongue. On the day prior to this report, the patient had bit their tongue bad, which had made their speech even worse. The patient¿s jaw was tight and they almost broke a tooth. Every time the patient had their ins replaced, it took them three months to get the ins properly adjusted and for them to receive any benefit. The patient also had an increase in rigidity and dystonia in their neck and extremities with their left being worse than the right. The patient met with their healthcare professional (hcp) a day prior to this report because their pain was so bad they thought they were having a heart attack. The pain was located in the patient¿s chest near the ins and in their armpits. An x-ray was done and the patient was going to follow up with their cardiologist. The patient was evaluated by their cardiologist and cardiac etiology was ruled out. Impedances were checked and one of the contacts was not being used. Impedances of electrode zero were measured to be greater than 40,000 ohms on the left side. The left ins was programmed to 2-, 3+ at 4. 7v, 90 usec, and 145 hz. Impedances of electrode three were measured to be greater than 40 ,000 ohms on the right side. The right ins was programmed to 1+, 2- at 4. 2v, 90 usec, and 145 hz. Therapy impedances were measured to be within normal limits on both sides. The patient¿s hcp planned on reprogramming the ins to get efficacy. The cause of the event was not determined. A troubleshooting revision had been scheduled for (b)(6) 2015 due to the high impedances. During the revision, the hcp opened the right incision and noticed the bottom two screws on the ins were not tightened. The hcp loosened all four screws, dried off the extension, and retightened everything. The right side bottom connector for the ins and extension still seemed not tight and there was a small gap, but everything was tightened down. Impedances were then tested and all impedances were within normal limits. The same issue occurred when the left side incision was opened. After the revision, all impedances were within normal limits on both sides and no further troubleshooting was done. Refer to manufacturer report #3004209178-2015-09832.

Manufacturer Narrative
Concomitant products: product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v475868, implanted: (b)(6) 2010, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2015, product type implantable neurostimulator; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v443426, implanted: (b)(6) 2010, product type lead. (b)(4).

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« Reply #69 on: July 15, 2015, 10:36:57 PM »

Model Number 3387S-40
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot# va0ery5, implanted: (b)(6) 2014, product type lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type extension. (b)(4).

Event Description
It was reported that there were wires left in the patient¿s brain because the healthcare professional had been afraid to remove them from the brain and it was causing the patient to not be able to breath correctly which was why he needed a continuous positive airway pressure (cpap) machine. The patient had very bad headaches. The patient¿s leads had started to make his head hurt. The leads gave the patient headaches that made migraines feel like nothing. The patient could feel the wire on the left side of his neck and stated that it was a long wire and the wire on the right was not as long as the wire on the left. The patient would get pain that started on the left side of the neck and then the pain spread to the right side of the neck and hits the forehead from temple to temple and then the pain attacked the eye so he would have to put on dark glass. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted. Reference manufacturer¿s report number: 6000153-2015-00119.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4865089
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dennis100
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« Reply #70 on: July 15, 2015, 10:37:53 PM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient complained of the bowstring effect and pulling in their neck when meeting with their healthcare professional (hcp) due to the implantable neurostimulator (ins) reaching elective replacement indicator (eri). The ins reaching eri was considered normal. Impedance testing was done and the cause of the event was determined to be the bowstring effect in the patient¿s neck. The hcp decided to replace both extensions. Following the revision, the issue was resolved.

Manufacturer Narrative
Concomitant medical products: product id: 37085-60, serial# (b)(4), implanted: 2009-(b)(6), explanted: 2015-(b)(6), product type: extension. Product id: 37085-60, serial# (b)(4), implanted: 2009-(b)(6), explanted: 2015-(b)(6), product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389s-40, lot# v279269, implanted: 2009-(b)(6), product type: lead. Product id: 3389s-40, lot# v285199, implanted: 2009-(b)(6), product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4862317
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dennis100
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« Reply #71 on: July 15, 2015, 10:39:32 PM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the last few weeks had been terrible for the patient. She fell several times and had to go to the emergency room (er) to determine if her kneecap was fractured. Her mental state was deteriorating rapidly, as she cried for the better part of a day because of frustration in not being able to walk ten feet without falling down. Her leg strength was completely gone and simply would not support her body. The patient also had significant pain in her neck that never seemed to diminish. Her right side was not functional and she had developed restless leg, which would not allow her to sleep for any length of time. She could barely perform the basic functions to care for herself. Her emotions were running sky high and the reporter¿s fear was that she was in so much agony that she may harm herself in a fit of anger. The patient had minimal trouble walking before implant, but could hardly walk at the time of the report. She was at the two month mark post-surgery and had seen little improvement in her condition. Her overall condition was significantly worse at the time of the report than prior to implant. The only caution presented prior to surgery was that her iq might drop a few points. The reporter felt this was an understatement as the patient was actually acting ¿like an eight year old. ¿ the reporter questioned her overall competency. Adjustments to the device had yielded little improvement. The patient could not go on like this much longer as her health was deteriorating rapidly. Follow-up from the manufacturer representative (rep) reported that there was 50% or greater symptom reduction. The patient had three programming sessions and had a follow-up appointment scheduled with her doctor for (b)(6) 2015. It was unknown how the patient was doing, but the therapy was being delivered. The patient had not had her appointment with her doctor yet, so additional information will be requested at a later date. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant product/(s): product id: 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37642,serial# (b)(4), product type: programmer, patient. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3387s-40, lot# va0q888, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0q888, implanted: (b)(6) 2015, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4841044
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dennis100
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« Reply #72 on: September 07, 2015, 07:51:33 AM »

Model Number 37612
Event Date 07/15/2015
Event Type Injury
Event Description
A consumer reported via a manufacturing representative that since (b)(6) 2015 the patient's neck muscle was rigid. No troubleshooting was done and the cause of the event was not determined. Reprogramming was done on (b)(6) 2015 and the patient's health care provider (hcp) determined the event was due to a short wire. There was no improvement in symptoms and the hcp suggested replacement.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5017767
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