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Author Topic: Deep brain stimulator - Extension  (Read 63732 times)
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dennis100
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« Reply #30 on: January 20, 2014, 10:33:57 PM »

Model Number IPGNEURO
Device Problem Break
Event Date 09/22/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Results: used for tunneler.

 
Event Description
It was reported the tunneler broke during a stage 2 implant case. The device broke at the distal portion of the carrier where it thins into the obturator. The surgeon had to explant the tunneler, make a counter incision, re-tunnel, and then secure the system. The patient was fine post-operatively, the event resulted in 45 minutes added to operative time. The extensions being placed were also replaced due to concern of damage, while explanting the tunneler. The devices were not saved to be retuned to the manufacturer.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1516346
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dennis100
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« Reply #31 on: January 20, 2014, 10:57:47 PM »

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
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dennis100
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« Reply #32 on: January 20, 2014, 10:59:03 PM »

Model Number IPGNEURO
Device Problem Break
Event Date 11/05/2009
Event Type  Malfunction 
Event Description
It was reported the extension carrier broke upon retrieval of extension from the device pocket. The pt recovered without sequela.

 
Manufacturer Narrative
(b) (4): the device has been returned to the mfr for analysis which is not complete as of the date of this report. A follow-up report will be sent when the analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1562856
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dennis100
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« Reply #33 on: January 20, 2014, 11:00:44 PM »

Model Number IPGNEURO
Device Problem Wire(s), breakage of
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: greenberg bd, gabriels la, malone da jr, rezai ar, friehs gm, okun ms, shapira na, foote kd, cosyns pr, kubu cs, malloy pf, salloway sp, giftakis je, rise mt, machado ag, baker kb, stypulkowski ph, goodman wk, rasmussen sa and nuttin bj. Deep brain stimulation of the ventral internal capsule/ventral striatum for obsessive-compulsive disorder: worldwide experience. Molecular psychiatry. 2008: 1-16. Summary: this article represents combined long-term (8 yrs; from 1998) results from the united states and europe of deep brain stimulation (dbs) of the ventral anterior limb of the internal capsule and adjacent ventral striatum (vc/vs) for severe and highly treatment-resistant obsessive-compulsive disorder. A total of 26 patients reveal clinically significant symptom reductions and functional improvement in about two-thirds of patients. Dbs was well tolerated overall and adverse effects were overwhelmingly transient. Results generally improved for patients implanted more recently, suggesting a 'learning curve' both within and across centers. None of the 26 patients were rated as globally 'worse' or 'slightly worse' after stimulation; 4 (15. 4%) were rated 'unchanged'; 5 (19. 2%) were rated 'slightly better' and 17 (65. 4%) were rated 'much better'. Event: a break in a stimulating lead or an extension wire requiring a replacement occurred in one patient. Refer to manufacturer report number: 3007566237-2009-08664.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1548577
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dennis100
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« Reply #34 on: January 22, 2014, 02:38:33 AM »

Model Number 7428
Device Problem Loose or intermittent connection
Event Date 01/28/2010
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
(b) (4).

 
Event Description
The deep brain stimulator was replaced. Afterward the pt experienced a lack of effect. The pt was seen in clinic 3 times since replacement. Impedances were around 1800 ohms (within formal limits); everything looked fine. The hcp decided to revise the system on (b) (6) 2010. Upon opening the pocket, it was discovered that the left and right extensions were loose in the connector block of the neurostimulator. The screws were re-tightened. The pt is doing much better now. The hcp was concerned that impedances were fine with loose connections.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1624516
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dennis100
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« Reply #35 on: January 22, 2014, 02:39:03 AM »

Device Problem Fracture
Event Date 01/26/2010
Event Type  Injury   Patient Outcome  Other
Event Description
An extension fractured and was removed. 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=1624517
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dennis100
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« Reply #36 on: January 22, 2014, 02:39:47 AM »

Device Problems Break; Kinked
Event Date 01/22/2010
Event Type  Malfunction 
Event Description
While tunneling the extensions, the extension carrier broke. An add'l skin incision had to be made to remove the broken carrier pieces. The extensions were kinked when they were removed. The hcp implanted new extensions. Post operatively, the pt was doing well. There was no injury associated with the event.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1618324
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dennis100
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« Reply #37 on: January 22, 2014, 02:40:35 AM »

Device Problem Material rupture
Event Date 12/22/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4). The extensions and the extension carrier have been returned to the mfr for analysis which is not complete as of the date of this report. A f/u report will be sent when the analysis is complete.

 
Event Description
While carrying the extension cables through the tunneling device, the tunneling device ruptured. The extension remained in the body of the pt and could only be removed by an add'l release incision behind the ear of the pt. The hcp implanted a new extension. Post operatively, the pt outcome was "ok".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1618325
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dennis100
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« Reply #38 on: January 22, 2014, 02:41:27 AM »

Model Number 7428
Device Problem No Information
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt experienced a loss of therapeutic effect starting two days before. It was stated that the wires pulled when the pt moved his neck; he had decreased range of motion. Pushing up on the ins towards the collar bone relieved the tightness of the wires. It was believed that if the ins was moved up 1/2 inch then it would release the tension. When the pt turned his head he saw the wires in his chest. It was further stated that the pt was getting the relief he needed but the leads were interfering with his head movement; he could feel them pull. The extensions were replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617633
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dennis100
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« Reply #39 on: January 22, 2014, 07:33:03 AM »

Model Number 7428
Device Problems High impedance; Expulsion
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The patient experienced no stimulation and a loss of therapeutic effect. An x-ray confirmed that the neurostimulator had flipped several times in the pocket and the wires may have gotten twisted. There may be a fracture in the extension wires. The lead impedance measurements were greater than 4,000 ohms on all the bipolar pairs when tested at 4v. A surgery has been scheduled for (b) (6) 2010 to replace the extensions.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1632033
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dennis100
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« Reply #40 on: January 22, 2014, 07:33:42 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
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dennis100
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« Reply #41 on: January 22, 2014, 07:34:25 AM »

Model Number 7428
Device Problem No Known Device Problem
Event Date 01/31/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
(b) (6), gross re, wire tethering or 'bowstringing' as a long-term hardware-related complication of deep brain stimulation. Stereotact funct neurosurg. 2009;87(6):353-359. Summary: the authors retrospectively reviewed the surgical database of a single neurosurgeon at (b) (6) from (b) (6) 2001 through (b) (6) 2009, comprising 278 pts with 456 electrodes implanted for all indications, identifying all pts presenting with the complaint of tightness, discomfort, prominence, or limitation of motion related to implantation of dbs systems. The article describes 6 pts with moderate to severe wire tethering. Reportable event: a (b) (6) male with a long history of medically intractable cervical dystonia manifesting as severe spasmodic leftward torticollis, laterocollis and intermittent retrocollis, underwent bilateral implantation of gpi placed dbs leads followed by implantation of both extension wires on the left (dual-unilateral) along with the generator in the left infraclavicular region. Ten weeks following surgery, it was noted that while the pt had received a good clinical benefit from the dbs, the extension cables felt excessively taut and bothersome. Examination revealed a very tight extension wire on the left side. At that time, although the implanted extension wires certainly contained sufficient length, it was hypothesized that with the pt's leftward torticollis the extension wires had scarred in at the ipg site preventing free movement, and a surgical revision was, therefore, performed of the ipg itself, "releasing" the excess loops of the extension wire. While the stress on the wire appeared to be relieved intraoperatively, when the pt awoke, it was apparent that the cable still was tight and protruding. The pt was, therefore, brought back the next day for a second revision to totally replace the extension cables, which were re-tunneled on the original (left) side but ostensibly through new tracks achieved by repositioning the connectors more posteriorly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1626552
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dennis100
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« Reply #42 on: January 22, 2014, 07:36:19 AM »

Model Number 7428
Device Problem No Known Device Problem
Event Date 01/31/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
(b) (9). Wire tethering or 'bowstringing' as a long-term hardware-related complication of deep brain stimulation. Stereotact funct neurosurg. 2009;87(6):353-359. Summary: the authors retrospectively reviewed the surgical database of a single neurosurgeon at (b) (6) from (b) (6) 2001 through (b) (6) 2009, comprising 278 patients with 456 electrodes implanted for all indications, identifying all patient presenting with the complaint of tightness, discomfort, prominence, or limitation of motion related to implantation of dbs systems. The article describes 6 patients with moderate to severe wire tethering. Reported event: one pt who had previously undergone 3 revision surgeries for tethering or "bowstringing" of the implanted extension wires (reference mfr report # 3007566237201001699 and 3007566237201001706), underwent a fourth revision where the scar was disconnected from the pulse generator pocket. When this did not relieve the protrusion, finally a procedure was performed where four separate 1 cm incisions where made along the scar whereupon the cord was visibly seen to abate if not disappear. This was done while the pt was awake to view the effects of the adhesion lysis under conditions of active muscle use. One month later the pt experienced total remission of this difficulty, and one and a half years later, the pt was markedly improved. See literature article with mfr report # 3007566237201001699.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1626554
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dennis100
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« Reply #43 on: January 22, 2014, 07:37:19 AM »

Model Number IPG
Device Problem No Known Device Problem
Event Date 01/31/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Miller pm, gross re. Wire tethering or 'bowstringing' as a long-term hardware-related complication of deep brain stimulation. Stereotact funct neurosurg. 2009;87(6):353-359. Summary: the authors retrospectively reviewed the surgical database of a single neurosurgeon at (b) (6) from (b) (6) 2001 through (b) (6) 2009, comprising 278 patients with 456 electrodes implanted for all indications, identifying all patients presenting with the complaint of tightness, discomfort, prominence, or limitation of motion related to implantation of dbs systems. The article describes 6 patients with moderate to severe wire tethering. One pt experienced tethering of "bowstringing" of the implanted extension wires requiring lysis treatment which resulted in some visible prominence of the wire but relieved the discomfort. It was noted this pt's onset may have followed an automobile accident.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1626561
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dennis100
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« Reply #44 on: January 22, 2014, 08:39:59 AM »

Model Number CARRIER
Device Problem Component(s), broken
Event Date 02/19/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).

 
Event Description
During tunneling of the extensions from the clavicular area to the area behind the ear, the doctor experienced friction, which was reported to be normal given the anatomical area. When pulling on the tunneler to retrieve it, suddenly the doctor felt no resistance at all anymore and he saw that he had retrieved only the metal part of the tunneler and the proximal part of the carrier. The carrier broke in 2 pieces. The distal part of the carrier, including the 2 heads of the extensions, were still in the patient and got stuck in the area behind the ear. The doctor tried to retrieve the system by pulling on the distal part of the extensions in the opposite direction, but it was impossible to retrieve them. The extensions are flexible and became elongated and damaged. Finally he had to open the area behind the ear to be able to retrieve the extension and distal part of the carrier. To finalize the operation, new extensions, tunneler and carrier were used in the same tunneling channel without any problem. There was reported to be no patient injury. The patient outcome was reported as "ok. ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1645617
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dennis100
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« Reply #45 on: January 22, 2014, 09:08:42 AM »

Device Problem Fracture
Event Date 01/14/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported when the doctor tunneled the extensions; the tunneler got stuck at the middle of the track during the second step of tunneling, when pulling backwards with the extensions in it. Because the profile of the "plastic straw" was wider than the metal part of it, it stuck in the middle of the track and broke. The doctor had to make another cut in the skin and go in and "dig" the torn extensions out. The patient outcome was good with no complications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614526
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dennis100
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« Reply #46 on: January 22, 2014, 09:09:29 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614478
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dennis100
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« Reply #47 on: January 22, 2014, 09:09:58 AM »

Device Problem Fracture
Event Date 01/05/2010
Event Type  Malfunction 
Manufacturer Narrative
(b) (4): analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

 
Event Description
It was reported that the tunneling tool with double port broke during the implant when pulling the extension back. The extension was deformed. There was no patient injury. A new extension was used to complete the implant.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617693
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dennis100
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« Reply #48 on: January 22, 2014, 09:10:32 AM »

Model Number 7428
Device Problem No Known Device Problem
Event Date 12/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
The device has been returned to the mfr for analysis which is not complete as of the date of this report. A f/u report will be sent when the analysis is complete.

 
Event Description
It was reported the pt had the device and extensions removed due to an infection. Cultures of the proximal and distal ends of the extensions indicated the infection was serratia marcessans. Add'l info has been requested, 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=1580209
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dennis100
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« Reply #49 on: January 22, 2014, 09:11:00 AM »

Model Number 7428
Device Problem No Information
Event Date 05/12/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that pt had a "repair" (extension replacement) of the dbs system that occurred in 2009. 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=1580211
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dennis100
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« Reply #50 on: January 22, 2014, 09:29:41 AM »

Model Number IPGNEURO
Device Problem Break
Event Date 12/17/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported as the tunneller, carrier, and extensions were being pulled from the site of the ipg pocket to the lead site (skull), the carrier broke within the tunneller. The carrier had snapped at the junction where the first of the extensions sits. An incision was made in the patient's neck to retrieve the extensions and the remainder of the tunneller. The extensions appeared to be intact and were tunneled the remainder of the distance up to the leads in the skull with no further event. The patient's status was uneventful after the device was removed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1582140
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dennis100
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« Reply #51 on: January 22, 2014, 09:30:15 AM »

Model Number 7428
Device Problem High impedance
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported impedance readings were >4000 ohms on some of the bipolar pairs. The pt was scheduled for a revision of the extension due to "tightness". The pt's symptom relief was reasonable.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1582382
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dennis100
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« Reply #52 on: January 23, 2014, 09:09:46 AM »

Model Number LEAD
Device Problems Difficult to position; Device operational issue
Event Date 03/31/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Literature: fytagoridis a, blomstedt p. Complications and side effects of deep brain stimulation in the posterior subthalamic area. Stereotact funct neurosurg. 2010;88(2):88-93. Summary: forty consecutive patients (67% men) operated with dbs in the posterior subthalamic area (psa) were analyzed for complications and side effects of the procedure. Twenty-seven patients had essential tremor, 8 had parkinson's disease, 2 had dystonic tremor, 1 had cerebellar tremor, 1 had neuropathic tremor and 1 writer's cramp. The mean age at surgery was ((b) (6)). The pts were followed for a mean time of 34 months (range 3-59). All procedures were performed by one surgeon during the period 2004-2008. Fifty-four dbs leads were implanted in these 40 patients, requiring a total of 57 tracks. Twenty-nine patients were operated in the left hemisphere, 7 in the right and 4 bilaterally. Four patients received an extra ipsilateral electrode in the psa due to an ambiguous response during perioperative stimulation of the original electrode. The pts were hospitalized for a mean of 7. 4 days (range 2-15). Reportable events: one procedure was aborted in the operation theatre and completed at a later occasion because the durotomy provoked a generalized seizure. One procedure was aborted in the operation theatre and completed at a later occasion due to suboptimal placement of the electrode in a pt too exhausted to allow a relocation of the electrode in the same session. Revision of the extension cables was performed in 2 patients due to straining and a feeling of tightness. One pt had an irritating granuloma removed from the infraclavicular scar. The implantable pulse generator malfunctioned in 1 patient with 2 ipsilateral electrodes. This problem was related to the stn electrode, and the clinical result was not affected. The source literature indicated the dbs lead models used were either 3387 or 3389, the electrodes were secured with a stimloc bur hole cover, extension models were not indicated, and the ipg model was 7428 (kinetra) in 37 of the 40 patients and model 7426 (soletra) in 3 of the 40 cases. The individuals and models for each event are unk.

 
Manufacturer Narrative
(b) (4). It was not possible to ascertain specific device info from the article. It is also possible several events occurred in one patient. At this time, no additional information was available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1676374
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« Reply #53 on: January 23, 2014, 09:10:25 AM »

Model Number UNKNOWN
Device Problems Fracture; Device or device fragments location unknown
Event Date 04/01/2010
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that the distal end of the carrier broke off into the pt's neck area when the extension was being pulled through. The doctor tried to locate the piece of carrier and remove it, but couldn't locate it. It was suggested that fluoroscopy be performed to see if the carrier piece could be located, but the doctor did not want to use fluoroscopy and decided to leave the piece of carrier inside the pt's body.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1674885
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« Reply #54 on: January 23, 2014, 09:43:17 AM »

Model Number 748ZA
Device Problems Break; False claim
Event Date 04/07/2010
Event Type  Malfunction   Patient Outcome  Other
Event Description
During surgical procedure to place a brain stimulator a small plastic piece of the extension kit broke off. The piece could not be located by x-ray or ct but is known to be located in the neck tissue and not in a vessel. Surgeon chose to leave piece in the pt as surgeon does not believe the piece will cause injury or harm to the pt. X-ray and ct failure to identify piece in the pt's neck. The brain stimulator was placed successfully despite the device issue.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1680176
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« Reply #55 on: January 23, 2014, 10:06:30 AM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1705667
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dennis100
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« Reply #56 on: January 23, 2014, 10:07:14 AM »

Model Number IPGNEURO
Device Problem Wire(s), breakage of
Event Date 04/12/2010
Event Type  Injury   Patient Outcome  Other
Event Description
A patient with deep brain stimulation (dbs) therapy and the implantable neurostimulator (ins) in an abdominal pocket presented with return of symptoms (tremor). The physician interrogated the ins and found it was on and regularly programmed. Impedances were about 200-300 ohms. During reprogramming attempts to try to regain dbs efficacy, when reaching high values (around 4/5v) patient referred pain, burning like sensation, at the pocket site. An x-ray of the pocket revealed that the extension appeared broken near the connection to the ins. The patient referred having a dog which often jumped on him. The physician stated that the patient had gained a lot of weight after implant, the extension might have been "trapped" by fibrosis and might not have been able to "follow" patient's very important abdominal enlargement. The physician explanted and replaced the extension. He found the old extension was torn in two pieces. With new extension, patient is well and dbs is effective. Old extension was thrown away by the physician because for him it was "reasonable" that the mentioned conditions could make the extension break. The extension was superficial and was also tunneled for a long path (from head to lower abdominal pocket). No injury to the patient was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1699458
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dennis100
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« Reply #57 on: January 25, 2014, 03:16:56 PM »

Model Number IPGNEURO
Device Problem Fitting problem
Event Date 07/01/2010
Event Type  Malfunction 
Event Description
It was reported that during an implant procedure, leads (model 3387-28) and extensions (model 37082) would not fit together. After tunneling the extensions to the implanted device and then trying to connect them with the 4 leads, the proximal part of the lead could not be inserted in a normal way. The physician had to drill out all 4 screws of the connector block of the extensions, and had to use an aqua dest for making it possible to get the lead into the connector block of the extension. It was noted to be very difficult and time consuming to bring the lead into the extension. It was noted that this had happened on two occasions on (b)(6) 2010 and (b)(6) 2010. See mfr report #3007566237-2010-05993.

 
Manufacturer Narrative
(b)(4). Reason for late mdr due to implementation of process improvement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1854245
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dennis100
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« Reply #58 on: January 25, 2014, 03:17:25 PM »

Model Number IPGNEURO
Device Problem No Information
Event Date 08/25/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that the tunneling tool with double port was broken during the implantation when pulling back the extension. The extensions were deformed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1848238
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dennis100
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« Reply #59 on: January 25, 2014, 03:18:04 PM »

Model Number 37085
Device Problem Material fragmentation
Event Date 07/15/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported the distal part of the extension carrier broke off under the skin in the neck/lower skull area. The broken portion was retrieved by neurosurgeon "when he cut off an extra 5 cm". Additional info has been requested and will be made as follow up as it becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1800012
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