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Author Topic: Deep brain stimulator - Neck  (Read 26695 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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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