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Author Topic: Deep brain stimulator - Leads  (Read 194902 times)
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dennis100
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« Reply #30 on: November 06, 2013, 12:20:43 AM »

Model Number IPGNEURO
Device Problem No Information
Event Date 07/11/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4): analysis of extension model 7482 serial number (b)(4) determined the # 0 and 3 conductors were broken at the weld. The conductor was broken at the distal end of the extension up to the transition point.
 
Event Description

It was reported that the patient's tremor increased and the lead impedance was checked. All electrodes showed over 2000 ohms. No stimulation occurred when the electrode settings were changed. The hcp suspected a fracture and an x-ray was taken. The extension fracture was observed in the x-ray, the hcp decided to replace. The extension was replaced (b)(6) 2011.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2201782
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dennis100
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« Reply #31 on: November 06, 2013, 12:21:11 AM »

Model Number IPGNEURO
Device Problems Fracture; High impedance
Event Date 06/01/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that there were high impedance readings on a lead. The physician opened the patient and tested the lead without the extension, which confirmed the high impedances. A lead fracture appeared to be visible. An appointment was going to be scheduled to replace the lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2149501

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dennis100
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« Reply #32 on: November 06, 2013, 12:21:46 AM »

Model Number IPGNEURO
Device Problem Buckled material
Event Date 04/15/2010
Event Type  Malfunction 
Event Description

The single set screw for the temporary deep brain stimulator lead cover seemed to bend/kink the lead at the point of contact between the #0 and #1 electrodes. Impedances were normal after the extension and battery were connected to the lead. 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=1686525
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dennis100
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« Reply #33 on: November 06, 2013, 12:22:06 AM »

Model Number IPGNEURO
Device Problem Wire(s), breakage of
Event Date 04/12/2010
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative

(b) (4).
 
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 #34 on: November 06, 2013, 12:22:27 AM »

Model Number IPGNEURO
Device Problems Fracture; High impedance
Event Date 05/06/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

When pt went to the hospital for programming, impedances were found to be higher than 2000 ohms. They opened and checked the lead. The lead broke at the position 2 to 3 cm up the joint. Additional info has been requested, a follow-up report will be sent if additional info becomes available.
 
Manufacturer Narrative

(b) (4). Final device analysis of the lead revealed a reliability non-conformance. All four conductors were broken 3. 5 cm from the proximal end of the lead. Visual observation noted that the conductor coils were crushed in multiple locations along the length of the lead. The lead was severely stretched and the conductors were pulled out of the tubing at the #3 electrode. The #3 conductor was broken at the #3 electrode weld site due to severe stretching of the lead at the electrode. The lead is stretched, the #0 connector is pulled out of place, and the #0 conductor broke at the #0 connector weld site. All the circuits were opened. There were no shorts between circuits.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1716162
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dennis100
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« Reply #35 on: November 06, 2013, 12:22:57 AM »

Model Number IPGNEURO
Device Problem Improper or incorrect procedure or method
Event Date 01/01/2010
Event Type  Malfunction 
Manufacturer Narrative

(b)(4).
 
Event Description

On (b)(6) 2010, it was initially reported that the proximal end of a lead was damaged during a stage 2 procedure. The physician cut off the last contact of the lead. The physician retained the existing lead. Patient programming was planned. On (b)(6) 2010, it was further reported that the physician had made an incision behind the patient's ear to expose the leads. The physician had trouble removing one of the temporary lead covers of the third contact. The set screw was found to be too tight and the physician could not get the screw to release. The physician then dissected the temporary lead housing, and the set screw did come off, however, the bottom contact was destroyed in the process. The entire contact came off, so the bottom contact was cut off. A company representative tested impedance, and all measurements came back normal even with the contact missing. It could not be recalled which side the contact was cut from. Stimulation was not 'pushed high enough' for the company representative to determine which side the contact was missing from (left or right). No device component was explanted. The patient was fine, however, the company representative did not consider the patient to be fully recovered due to the faulty lead. Additional information will be provided in a follow-up report as it becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1899777

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dennis100
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« Reply #36 on: November 06, 2013, 12:23:17 AM »


Model Number IPGNEURO
Device Problem Fracture
Event Date 09/28/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4). The lead has been returned to the mfr for analysis which is not complete as of this report. A f/u report will be sent when the analysis is complete.
 
Event Description

It was reported the pt's lead was found to be broken by the health care provider. The lead was replaced and the pt recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1895278

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« Reply #37 on: November 06, 2013, 12:23:39 AM »

Model Number IPGNEURO
Device Problem Wire(s), breakage of
Event Date 04/01/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

Literature: vergani f, landi a, pirillo d, cilia r, antonini a, sganzerla ep. Surgical, medical, and hardware adverse events in a series of 141 patients undergoing subthalamic deep brain stimulation for parkinson disease. World neurosurg. Apr 2010;73(4):338-344. Summary: the authors reported a single center, retrospective analysis of complications in a large population of parkinsonian patients with a long-term follow-up (mean, 4. 6 years). A total of 141 patients underwent bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) between (b)(6) 1998 and (b)(6) 2007. In this series, neither seizures nor extradural/subdural hematomas were observed. Reportable event: one patient presented with an extension wire breakage at the infraclavicular level. No history of trauma was reported. An extension wire replacement was necessary. This complication required a longer in-hospital stay for the patient.
 
Manufacturer Narrative

(b)(4). 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=1895265

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dennis100
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« Reply #38 on: November 06, 2013, 12:24:11 AM »

Event Date 08/20/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Broken lead wire "cracked" batteries "dead".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1820865
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dennis100
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« Reply #39 on: November 06, 2013, 12:24:35 AM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 09/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

The pt had dbs device implanted five years ago. In (b)(6), the doctor found the lead exposed. The lead was changed on (b)(6). The pt is well now.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1910483
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dennis100
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« Reply #40 on: November 06, 2013, 12:25:05 AM »

Device Problems Fracture; High impedance
Event Date 07/01/2011
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that the pt experienced a return of parkinson's symptoms. X-rays confirmed a break of the lead, 2-3 cm from the connection with the extension. Impedence readings confirmed the break of the lead, showing readings greater than 4,000 ohms. The lead was removed and replaced. There was no pt injury. The pt was noted to be "ok" following the procedure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2212631

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dennis100
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« Reply #41 on: November 06, 2013, 12:25:30 AM »

Model Number IPGNEURO
Device Problem Fracture
Event Date 03/01/2011
Event Type  Injury   Patient Outcome  Congenital Anomaly
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. The pt info provided in section a is the average for all the pts. At this time no additional info was available, additional info regarding the pt and device has been requested.
 
Event Description

Literature: shahlaie k, larson paul s, starr philip a. Intraoperative computed tomography for deep brain stimulation surgery: technique and accuracy assessment. Neurosurgery. 2011;68(1 suppl operative):114-124; discussion 124. Www. Neurosurgery-online. Com. Doi: 10. 1227/neu. 0b013e31820781bc. Summary: the authors reported on a series of 15 patients undergoing frame-based stereotactic placement of deep brain stimulators with intraoperative computed tomography (ct) to confirm lead placement. The o-arm ct is fused to the preoperative imaging to provide the location of the implanted lead in stereotactic space. Reportable event: the authors report that in one pt they performed a lead replacement of an existing globus pallidus internus lead that was fractured without microelectrode recording. The lead was removed and replaced to a more lateral position. The source literature did not specify which device models were used.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2234566

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dennis100
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« Reply #42 on: November 06, 2013, 12:25:49 AM »

Model Number IPGNEURO
Device Problem Malposition of device
Event Date 08/19/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the leads were not placed deep enough and the pt got no improvement from the deep brain stimulation therapy. The leads were replaced on (b)(6) 2011. Refer to manufacturer report# 3007566237201107067.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2234533

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dennis100
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« Reply #43 on: November 06, 2013, 12:26:08 AM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 05/08/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: kluger bm, foote kd, jacobson ce, okun ms, lessons learned from a large single center cohort of patients referred for dbs management. Parkinsonism relat disord. 2011;17(4):236-239. Www. Elsevier. Com/locate/parkreldis. Doi:10. 1016/j. Parkreldis. 2010. 05. 003. Summary: the authors prospectively collected data on 108 patients who had received dbs surgery for the treatment of parkinson's disease, essential tremor, dystonia or other, at an outside institution and who were referred for further management in order to uncover potential lessons to optimize dbs. Reportable event: ninety percent of patients reported at least one area of symptomatic dissatisfaction with the results of their dbs. Common issues included pre-operative misdiagnosis ((b)(6)), presence or exacerbation of symptoms not addressable by current dbs technology ((b)(6)), lead misplacement ((b)(6)), and need for medication ((b)(6)) or dbs programming ((b)(6)) optimization. Overall, (b)(6) of subjects had no improvement, (b)(6) slight improvement and (b)(6) large improvement after medical and/or surgical management.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2245657

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dennis100
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« Reply #44 on: November 06, 2013, 12:26:31 AM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 11/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Received info reporting a pt who will be scheduled for a lead revision because the lead pulled out 9 mm. The lead was secured with a stimloc when it was implanted on (b)(6) 2010 and post-operative mri of the brain on (b)(6) 2010 shows leads in place. Ipg was implanted on (b)(6) 2010 and post operative skull x-ray shows migration of the left lead. Lead revision and or replacement surgery has yet to be scheduled. At this time, stimulation has not been turned on. Add'l info has been requested and if received, a f/u report will be sent. Reference mfr report # 3007566237-2010-09867.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1910711

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« Reply #45 on: November 06, 2013, 12:26:51 AM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 11/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Received info reporting a pt who will be scheduled for a lead revision because the lead pulled out 9 mm. The lead was secured with a stimloc when it was implanted on (b)(6) 2010, and post-operative mri of the brain on (b)(6) 2010, shows leads in place. Ipg was implanted on (b)(6) 2010, and post operative skull x-ray shows migration of the left lead. Lead revision and or replacement surgery has yet to be scheduled. At this time, stimulation has not been turned on. Additional info has been requested and if received, a follow up report will be sent. Reference mfr report 3007566237201009869.
 
Manufacturer Narrative

(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1910699
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« Reply #46 on: November 06, 2013, 12:27:14 AM »

Model Number IPGNEURO
Device Problem Malposition of device
Event Date 02/16/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

Literature: o'sullivan d, pell m. Long-term f/u of dbs of thalamus for tremor and stn for parkinson's disease. Brain res bull 2009; 78 (2-3): 119-121. Summary: dbs of the vim nucleus of the thalamus maintains long-term benefit for tremor due to essential tremor or to severe tremulous parkinson's disease. As far as bilateral stn stimulation, it maintains the benefit for the movement disorder aspect of parkinson's disease, such as tremor, rigidity and bradykinesia, but in the author's experience, does not prevent the progression of the disease and therefore is of no benefit for the non-dopaminergic aspects of the disease. Reportable event: it was reported that the pt improved over a 2-year period and then developed dystonic features due to the disease and medication, and has had repeat surgery with benefit. The hcp indicated that the repeat surgery was to reposition the leads as they were placed suboptimally. The hcp indicated that they did not believe the symptoms were exacerbated due to the system. No system components were returned to the manufacturer.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1910977

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« Reply #47 on: November 06, 2013, 12:27:35 AM »

Model Number IPGNEURO
Device Problems Malposition of device; Battery issue
Event Date 04/30/2010
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative

(b)(4) suicide -(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with the previously reported events. It is also possible several events occurred in one pt. The pt info provided in section a is the average for all the pts. At this time no additional info was available, additional info has been requested.
 
Event Description

Literature: kishore a, rao r, krishnan s, et al. Long-term stability of effects of subthalamic stimulation in parkinson's disease: indian experience. Mov disord. Oct 30 2010; 25(14):2438-2444. Summary: the authors reported on 45 consecutive pts who received bilateral subthalamic nucleus (stn) stimulation for parkinson disease (pd) from 1999 to 2004. Of the 45 pts, 18 were women and 27 men; their average age was 44. 1 years. Pts showed a stable and substantial reduction in the cardinal signs of pd, motor fluctuations, and dyskinesias, but less so for axial signs. The reduction in medications and the intensity of electrical stimulation needed also remained stable during follow up. This is the first report of stn stimulation in asian pts with pd. Reportable events: the authors indicated that there were several complications of subthalamic stimulation: they are summarized below: two pts experienced intra operative seizures; both were small pneumocephalus; one pt experienced fluid collection at the battery implantation site necessitating reimplantation; two pts experienced hardware failure of the battery (unspecified); two pts experienced led repositioning; one pt experienced a fall and lead breakage; one pt experienced new-onset of severe depression; eight pts experienced new-onset of apathy; one pt committed suicide at 4 years. The source literature did not specify which device models were used.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1909862
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dennis100
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« Reply #48 on: November 06, 2013, 12:27:56 AM »

Model Number IPGNEURO
Device Problem Connection issue
Event Date 04/01/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative

(b)(4).
 
Event Description

Literature: vergani f, landi a, pirillo d, cilia r, antonini a, sganzerla ep. Surgical, medical, and hardware adverse events in a series of 141 patients undergoing subthalamic deep brain stimulation for parkinson disease. World neurosurg. Apr 2010;73(4):338-344. Summary: the authors reported a single center, retrospective analysis of complications in a large population of parkinsonian patients with a long-term follow-up (mean, 4. 6 years). A total of 141 patients underwent bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) between (b)(6) 1998 and (b)(6) 2007. In this series, neither seizures nor extradural/subdural hematomas were observed. Reportable event: one patient presented a current dispersion at the connection between the electrode and the extension wire. Intraoperative electrical tests of resistance and current outflow were carried out for every contact of the electrode, showing its good functioning. The extension wire was then replaced, with a good reprise of stn dbs. This complication required a longer in-hospital stay for the patient.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1895263
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« Reply #49 on: November 06, 2013, 12:28:20 AM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 04/01/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

Literature: vergani f, landi a, pirillo d, cilia r, antonini a, sganzerla ep. Surgical, medical, and hardware adverse events in a series of 141 patients undergoing subthalamic deep brain stimulation for parkinson disease. World neurosurg. Apr 2010;73(4):338-344. Summary: the authors reported a single center, retrospective analysis of complications in a large population of parkinsonian patients with a long-term follow-up (mean, 4. 6 years). A total of 141 patients underwent bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) between november 1998 and december 2007. In this series, neither seizures nor extradural/subdural hematomas were observed. Reportable event: one patient had a major infection that started from the ipg and rapidly extended along the extension wires. Cultures were negative however, both the ipg and extension wires were removed to achieve infection healing and to prevent intracranial dissemination of the infection. Antibiotic therapy was maintained for at least 3 weeks. This patient was not reoperated because of a poor response on that side to the stndbs. This complication required a longer in-hospital stay for the patient however, the patient did not show significant comorbidity.
 
Manufacturer Narrative

(b)(4). 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=1895249


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« Reply #50 on: November 06, 2013, 12:28:55 AM »

Model Number IPGNEURO
Device Problem Impedance issue
Event Date 09/25/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

Information received reports the ins was changed in 2009 and afterwards the patient complained the effect was not good. It was felt the "muscular tension" was very high and several attempts at reprogramming were unsuccessful. When the physician "pressed the external ear connector, it was controlled and the impedance was lower". The problem happened again and the impedances reached >37000 ohms and muscular rigidity happened again. During revision surgery the physician found the connector was not good.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1907206
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« Reply #51 on: November 06, 2013, 12:29:28 AM »

Model Number IPGNEURO
Event Date 04/01/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

Literature: vergani f, landi a, pirillo d, cilia r, antonini a, sganzerla ep. Surgical, medical, and hardware adverse events in a series of 141 patients undergoing subthalamic deep brain stimulation for parkinson disease. World neurosurg. Apr 2010;73(4):338-344. Summary: the authors reported a single center, retrospective analysis of complications in a large population of parkinsonian patients with a long-term follow-up (mean, 4. 6 years). A total of 141 patients underwent bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) between november 1998 and december 2007. In this series, neither seizures nor extradural/subdural hematomas were observed. Reportable event: one patient presented with skin erosion along the extension wire, with no signs of infection. The extension wire was removed to allow for a better wound healing. A successful reimplantation of the wire was performed 6 months later. This complication required a longer in-hospital stay for the patient.
 
Manufacturer Narrative

(b)(4). 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=1895247
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« Reply #52 on: November 06, 2013, 12:29:51 AM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 09/01/2010
Event Type  Injury   Patient Outcome  Hospitalization,Life Threatening,Required Intervention
Manufacturer Narrative

(b)(4). It is not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no additional info was available, additional info has been requested.
 
Event Description

Literature: hyam ja, de pennington n, joint c, et al. Maintained deep brain stimulation for severe dystonia despite infection by using externalized electrodes and an extracorporeal pulse generator. J neurosurg. Sep 2010;113(3):630-633. Summary: the authors present two cases of severe dystonia in which deep brain stimulation was maintained despite the presence of infection at the site of the pulse generator, using ongoing stimulation by externalization of electrode wires and an extracorporeal pulse generator. This allowed the infection to clear and wounds to heal while maintaining stimulation. Reportable event: a (b)(6) girl with a 6-year history of medically intractable generalized tonic dystonia (dyt1 negative) underwent bilateral implantation of deep brain electrodes in the globus pallidus internus. Six months after the procedure, there was a 65% decrease in her bfmdrs score. This marked improvement gave her the ability to play independently for the first time, but 10 months after surgery she dislodged one of her electrodes while testing this freedom by sliding down a staircase on her abdomen. Her symptoms worsened, and her displaced electrode was revised. Following revision she developed a spreading infection from the abdominal would that failed to respond to broad-spectrum intravenous antibiotics. She developed signs of systemic sepsis, and the entire dbs system was removed. The sudden loss of stimulation precipitated a dystonic crisis, which compromised her respiratory function and necessitated emergency intubation and ventilation for 21 days. To allow wearing of ventilatory support, a dbs system was implanted despite the likely continued presence of infection. Over the next 6 years she underwent 11 further procedures to replace her pulse generators and deal with recurrent wound infections. Multiple wound swabs were taken but only one exhibited positive growth, a methicillin-sensitive staphylococcus aureus. Throughout most of this time, the pt received oral rifampicin and several courses of intravenous antibiotics. Dermatological skin patch testing was negative for sensitivity to pulse generator components. Although she remained systemically well, her dystonia deteriorated. Her entire system was revised 6 years after her original surgery, and the extension cables tunnelled along new paths to a new pulse generator implanted deep to the rectus abdominis muscle. Unfortunately after 6 months, the abdominal wound dehisced again. The authors believed that her recurrent wound problems were due to chronic hardware-related infection, and therefore, they externalized her existing pulse generator to the now extracorporeal, resterilized pulse generator. The pulse generator remained externalized for 4 months within an improvised carrying pouch; once all wounds were healed; new extension leads were tunnelled from the head to a new pulse generator placed in a new subpectoral wound. All antibiotics had been stopped for 18 months, inflammatory markers were normal, and all wounds had healed well. The pt's dystonia has improved again to the level initially achieved following her first surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1907359

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dennis100
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« Reply #53 on: November 06, 2013, 12:30:20 AM »


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 #54 on: November 06, 2013, 12:30:48 AM »

Model Number IPGNEURO
Device Problem High impedance
Event Date 07/28/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the pt was not responding to the stimulation and had a return of symptoms. The physician suspected to a device problem and on a f/u visit impedance measurements with soletra showed >2000 ohms. Test with a external device showed >18,000 ohms on all conductors. The lead was replaced and the pt was reported as "okay".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1823487


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dennis100
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« Reply #55 on: November 06, 2013, 12:31:13 AM »

Model Number IPGNEURO
Device Problem Device operational issue
Event Date 07/26/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

The patient experienced a "tremble" in the right side. The doctor thought it happened due to a lead problem. The patient had an operation to change the lead. To ensure the smooth operation, the doctor cut the older lead and pull it out. Additional information was requested.
 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1817759

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dennis100
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« Reply #56 on: November 06, 2013, 12:31:36 AM »

Model Number IPGNEURO
Device Problem Inappropriate shock
Event Date 05/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

The patient no longer had effective stimulation. The patient experienced a shock. Leak breakage was suspected. The lead was replaced. There was reported to be no patient injury. The patient was "fine" following the lead replacement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1723620

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dennis100
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« Reply #57 on: November 06, 2013, 12:32:06 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 10/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

Literature: bronte-stewart h, louie s, batya s, henderson jm. Clinical motor outcome of bilateral subthalamic nucleus deep-brain stimulation for parkinson's disease using image-guided frameless stereotaxy. Neurosurgery. Oct 2010;67(4):1088-1093; discussion 1093. Summary: the authors reported on a group of 20 men and 11 women with parkinson's disease (mean age of 62 yrs). Twenty-eight subjects had bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) and 3 had unilateral stn dbs using a frameless approach. The authors indicated that their outcomes results are comparable to those reported with the use of the framed-based technique. All pts had postoperative ct scans within 6 hrs of the procedure; mild pneumocephalus was common, but there were no intracranial hemorrhages. Reportable event: this report is for one pt who developed postoperative infection requiring dbs lead removal, intravenous antibiotics, and subsequent reimplantation. The source literature did not specify which device models were used.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1915074

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dennis100
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« Reply #58 on: November 06, 2013, 12:32:29 AM »

Device Problem Disconnection
Event Date 11/01/2010
Event Type  Malfunction 
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the pocket adaptor pulled out of the deep brain stimulator header. 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=1944308
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dennis100
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« Reply #59 on: November 06, 2013, 12:32:53 AM »

Model Number IPGNEURO
Device Problems Break; Impedance issue
Event Date 01/01/2010
Event Type  Malfunction 
Event Description

The pt experienced a worsening of his motor symptoms. Device interrogation revealed abnormal impedances. The lead looked broken on x-ray. Implant of a new lead was planned. Add'l info has been requested. A follow-up report will be submitted if add'l info becomes available.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1934208
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