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Author Topic: Deep brain stimulator - Leads  (Read 194964 times)
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dennis100
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« on: November 06, 2013, 12:07:05 AM »

Model Number IPGNEURO
Device Problems Fracture; Device Issue; Positioning Issue
Event Date 08/01/2010
Event Type  Death   Patient Outcome  Death,Required Intervention
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 add'l info was available, add'l info has been requested.
 
Event Description

Literature: burdick ap, fernandez hh, okun ms, chi yy, jacobson c, foote kd. Relationship between higher rates of adverse events in deep brain stimulation using standardized prospective recording and pt outcomes. Neurosurg focus. Aug 2010;29(2):e4. Summary: the authors disclose the standardized and prospectively recorded ae data from their institution between (b)(6) 2002 and (b)(6) 2008. Two hundred seventy dbs procedures were performed in 198 pts; 26 pts had dystonia, 43 had essential tremor, 113 had parkinson disease, 6 had ocd, and 10 had other causes of tremor. The dbs leads were implanted on the left hemisphere in 133 procedures, on the right in 88, and bilaterally in 49. A total of 300 aes were recorded in 146 of the 270 procedures, and the aes were recorded in 119 of 198 pts. No significant qol differences. Event: the frequency of the 300 adverse events were as follows: mental status decline 53, other (unspecified) 43, gait problem 21, other motor problem 20, seizure 16, ich (symptomatic) 16, lead misplacement 15, speech-aphasia 13, speech-dysarthria 11, subdural/other bleed 11, mania/hypomania 8, infection, deep (hardware removal) 7, air embolus 6, speech-hypophonia 6, depression 6, infection, deep (revision, iv antibiotics) 5, swallow problem 5, anxiety 5, incontinence 4, visual problem 4, infection, superficial (oral antibiotics) 4, hardware malfunction (other) 4, death 2, hardware malfunction (fracture) 2, hydrocephalus 2, neurological deficit (other) 2, stroke 2, scalp erosion 2, suicidal ideation 2, ipg seroma 1, other sensory problem 1 and psychogenic disorder 1. See attached literature article.
 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885229

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dennis100
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« Reply #1 on: November 06, 2013, 12:07:30 AM »

Model Number IPGNEURO
Device Problems Fracture; No Information
Event Date 03/08/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: moro e, lozano am, pollak p, et al. Long-term results of a multicenter study on subthalamic and pallidal stimulation in parkinson's disease. Mov disord. 04/15/2010;25(5):578-586. Summary: this article reported the 5 to 6 year follow-up of a (b)(4) study of bilateral subthalamic nucleus (stn) and globus pallidus internus (gpi) deep brain stimulation (dbs) in advanced parkinson's disease (pd) patients. Thirty-five stn patients and 16 gpi patients were assessed at 5 to 6 years after dbs surgery. Primary outcome measure was the stimulation effect on the motor unified parkinson's disease rating scale (updrs) assessed with a prospective cross-over double-blind assessment without medications (stimulation was turned on and off randomly). Secondary outcomes were motor updrs changes with unblinded assessments in off- and on- medication states, with and without stimulation, activities of daily living, anti-pd medications, and dyskinesias. The patients had been implanted with bilateral gpi- or stn-dbs between (b)(6) 1996 and (b)(6) 1998 and also had been assessed at a 3-4 year follow-up, the results of which have been reported elsewhere. Reportable events: one gpi-dbs patient underwent surgery for a lead fracture. One gpi-dbs patient who lost dbs motor benefit between the 3-4 year evaluation and the 5-6 year follow-up underwent successful bilateral stn-dbs. It was hypothesized that the loss might have been due to suboptimal placement of the electrode inside the pallidum. One gpi-dbs patient had the leads and ipg's explanted and not replaced between the 3-4 year evaluation and the 5-6 year follow-up. No other information was provided. One stn-dbs patient had the ipg explanted prior to the 3-4 year follow-up. No other information was provided. Two patients with stn-dbs underwent lead replacements. No other information was provided. One patient with stn-dbs underwent replacement of the ipg and extension. No other information was provided.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. It is also possible several events occurred in one patient. At this time no additional information was available, additional information regarding the patient, event, interventions and outcome has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107174

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dennis100
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« Reply #2 on: November 06, 2013, 12:08:52 AM »

Device Problems Fracture; Device Issue
Event Date 11/13/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4). A copy of this article is available on the world wide web at http://thejns. Org/doi/pdf/10. 3171/2009. 10. Jns09371.
 
Event Description

Literature: zhang k, bhatia s, oh my, cohen d, angle c, whiting d. Long-term results of thalamic deep brain stimulation for essential tremor. J neurosurg. Jun 2010;112(6):1271-1276. Summary: this article discusses long-term follow-up of 34 pts with essential tremor who were treated with deep brain stimulation (dbs) of the ventral intermediate nucleus of the thalamus (vim) between (b)(6) 1998 and (b)(6) 2005. The tremor and handwriting components of the fahn-tolosa-marin clinical tremor rating scale were assessed pre- and post-operatively. Follow-up was performed at routine visits, usually every 3-6 months. Pts were also contacted by phone for comprehensive evaluation of therapeutic efficacy in (b)(6) 2006 (n=22) and (b)(6) 2008 (n=12). The average follow-up period was 56. 9 months. Event: one pt experienced erosion of the incision that was treated with incision and debridement. The pt also experienced overt infection and the system was removed prior to the 2006 follow-up. The timing of these events was unclear. One pt experienced erosion of the incision that was treated with incision and debridement. The pt also experienced overt infection and the system was removed between the 2006 and 2008 follow-ups. The timing of these events was unclear. One pt had the system removed due to infection. The system was explanted and reimplanted several months later. Four pts underwent replacement of the leads due to lead fracture. One pt underwent replacement of the extension due to "malfunction. " it was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. 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, event, interventions and outcome has been requested.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129806
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dennis100
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« Reply #3 on: November 06, 2013, 12:09:31 AM »

Model Number IPGNEURO
Device Problem Low impedance
Event Type  Malfunction 
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that low impedances of 6 ohms were measured on contacts 1 and 3. Another lead was used with impedances over 4000 but therapeutic effect was good.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2275455

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dennis100
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« Reply #4 on: November 06, 2013, 12:09:58 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 10/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
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 infections requiring dbs lead removal, intravenous antibiotics, and subsequent reimplantation. The source literature did not specify which device models were used.
 
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. (b)(6). At this time no add'l info was available, add'l info has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1915110

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dennis100
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« Reply #5 on: November 06, 2013, 12:10:25 AM »

Device Problems Fracture; High impedance
Event Date 09/12/2011
Event Type  Malfunction 
Event Description

It was reported that the patient experienced a return of parkinson's symptoms, at a follow-up examination. X-rays confirmed that the leads were broken a few centimeters above the connection. Impedance readings were greater than 4,000 ohms, and also confirmed the break of the leads. It was noted that there was no injury to the patient. As of the date of this report, the patient received therapeutic effect on only one side, and was further treated with an increase in the dosage of medication. There was no device system revision planned. Additional information was requested but not available as of the date of this report. A follow-up report will be filed if additional information becomes available.
 
Manufacturer Narrative

(b)(4).
 
Manufacturer Narrative

Analysis of lead model 3389-40 lot # unk determined the conductor was broken and stretched due to overstress damage. There were no shorts between circuits and an open circuit was found in segment 1. The proximal end was not returned.
 
Manufacturer Narrative

Additional information from analysis of the lead model 3389-40, lot # unk showed that the broken conductor was within 10 cm of the connector area. All of the conductors were observed to be broken 43 cm from the distal end of the lead. The outer insulation was cut with cosmetic environmental stress cracking noted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2278604

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dennis100
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« Reply #6 on: November 06, 2013, 12:10:49 AM »

Model Number UNKNOWN
Device Problem Fracture
Event Date 09/07/2011
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that, during perioperative tunneling, the obturator that was supposed to hold the lead inside the extension passer, broke. The lead got stuck in the middle of the pt's neck. It was necessary to make an additional small incision in the pt's neck in order to move the lead into the correct location. The pt experienced no further issues, and there was no injury to the pt. The pt was "fine," and received good therapeutic effect from the stimulation.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2265234

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dennis100
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« Reply #7 on: November 06, 2013, 12:11:13 AM »

Model Number IPGNEURO
Device Problem No Information
Event Date 01/01/2000
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the patient had a deep brain stimulation system (dbs) implanted in 1995. In 2000, the patient had a second lead implanted. It was stated that the second lead implant procedure was "complicated by hemorrhage. " no other details were provided. No further follow up is possible.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2276354

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dennis100
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« Reply #8 on: November 06, 2013, 12:11:39 AM »

Model Number IPGNEURO
Device Problem Difficult to insert
Event Date 09/27/2011
Event Type  Malfunction 
Event Description

Additional information received reported that the patient had been switched on with no issues to report. The patient was scheduled to be reviewed after one month.
 
Event Description

It was reported that during the implant procedure of four deep brain stimulation leads in a pediatric patient, it was not possible to insert the leads into the connectors of the two bifurcated extensions beyond the second connection in the extension. Forceps were used to hold both the leads and the extensions. It was the second contact on all four extension channels where the lead stopped. A blunt needle was passed through the extension channel to insure that there was no blockage and the needle appeared to pass through fine. The leads then were passed through again. This time the leads went through but still with some resistance. The leads and extensions were implanted. No impedance measurements were taken. At the time of this report, the patients system had not yet been switched on. Additional information has been requested, a follow-up report will be sent if additional information becomes available.
 
Manufacturer Narrative

(b)(4).
 
Manufacturer Narrative

Lead model 3389-28 lot# 0205400514 implanted: unknown explanted: unknown, lead model 3389-28 lot# 0205400513 implanted: unknown explanted: unknown, lead model 3389-28 lot# 0205398913 implanted: unknown explanted: unknown, lead model 3389-28 lot# 0205398001 implanted: unknown explanted: unknown.
 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2291592
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dennis100
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« Reply #9 on: November 06, 2013, 12:12:01 AM »

Model Number IPGNEURO
Device Problems High impedance; Device operates differently than expected
Event Date 09/22/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

Analysis of the lead found the proximal end was stretched and insulation was broken underneath the #0 connector sleeve. No setscrew marks were observed. The conductors were stretched and conductor coils were crushed. The #0 and #1 conductors were broken at the #0 and #1 connector weld site from overstress/damage. The outer insulation was intact, and the distal end was ok. There were open circuits.
 
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the system had impedances of over 4,000 ohms on the lead, even when measured at 5 volts. Parkinson symptoms worsened over night. Intraoperative measurement of the extension and lead showed impedances over 4,000 ohms. The connection between the extension and the deep brain stimulation lead was opened and it was seen that the lead was damaged at the distal part. The lead was replaced with a lead of the same model, and the patient continued with deep brain stimulation therapy. Additional information was requested, but was not available as of the date of this report.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2281206
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dennis100
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« Reply #10 on: November 06, 2013, 12:12:27 AM »

Model Number IPGNEURO
Device Problem Device operates differently than expected
Event Date 09/28/2011
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that a lead revision took place (b)(6) 2011. Group impedances inter-operatively of the new lead were 198 ohm. The pt had a positive result after the revision.
 
Manufacturer Narrative

(b)(4).
 
Manufacturer Narrative

Analysis of the lead model 3587 lot unknown found no significant anomaly. The proximal end of the lead was ok and there were setscrew marks in the correct location. The lead conductors were ok. The outer insulation was cut 3. 1cm from the proximal end in suspected explant damage. There were suspected body fluids observed in the lead. The distal end of the lead was ok. Continuity was acceptable and there were no shorts between circuits.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2297805
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dennis100
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« Reply #11 on: November 06, 2013, 12:12:50 AM »

Model Number IPGNEURO
Device Problem Break
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the pt's lead was replaced in 2009 due to a lead break. A second lead was found to be broken in (b)(6) 2011. The lead was replaced. No pt symptoms or outcome were reported. Additional info has been requested but was not available as of the date of this report.
 
Manufacturer Narrative

 
Event Description

Additional information received reported that it was unknown what symptoms the patient experienced as a result of the lead break. The patient outcome was "good".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2301799
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dennis100
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« Reply #12 on: November 06, 2013, 12:13:10 AM »

Model Number NEU_INS_STIMULATOR
Device Problems High impedance; Device markings issue
Event Date 12/19/2011
Event Type  Malfunction 
Event Description

It was reported that the mark was missing on the extension, thus safe handling was not possible when introducing the electrode. All impedances were over 40,000 ohms, except 8 and case which measured 1050 ohms at the pole 8-11. There was no patient injury.
 
Manufacturer Narrative

Extension model 37085, serial# unknown, implanted: (b)(6) 2011, explanted unk.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2415915
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dennis100
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« Reply #13 on: November 06, 2013, 12:13:30 AM »

Model Number NEU_INS_STIMULATOR
Device Problem Device operates differently than expected
Event Date 01/17/2012
Event Type  Malfunction 
Manufacturer Narrative

Lead model 3387 lot# unknown implanted (b)(6) 2012 explanted (b)(6) 2012. Analysis results were not available as of the date of this report. A follow up report will be submitted when analysis is complete.
 
Event Description

It was reported that one contact on the lead did not work. The lead was replaced and there was no patient injury.
 
Manufacturer Narrative

Analysis of the lead model 3387 found no anomaly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2453754

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dennis100
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« Reply #14 on: November 06, 2013, 12:13:57 AM »

Device Problem Melted
Event Type  Malfunction 
Event Description

Additional information received reported the event did not occur with any patients. The physician was concerned of the possibility of the event occurring.
 
Event Description

It was reported that the proximal end of the extension can be damaged/melted when using electrocautery to remove the neurostimulator from the pocket during neurostimulator revisions. Details regarding specific instances where this had occurred were not provided.
 
Manufacturer Narrative

Extension model 37085 serial# unknown implanted unk explanted unk.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2464799
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dennis100
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« Reply #15 on: November 06, 2013, 12:14:21 AM »

Model Number NEU_INS_STIMULATOR
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that the lead had to be replaced because of dysfunction. Additional information has been requested, but was not available as of the date of this report.
 
Manufacturer Narrative

(b)(4): lead model 3889, lot# unknown, implanted: unknown, explanted: 2012-(b)(6). (b)(4): analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.
 
Manufacturer Narrative

Analysis of the lead model# 3389, found no significant anomaly. The lead was stretched at the proximal end. The conductor coil was crushed at one point in the lead. Functional test found continuity acceptable at all circuits as well as no shorts.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2634999
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« Reply #16 on: November 06, 2013, 12:14:45 AM »

Model Number NEU_INS_STIMULATOR
Event Date 09/01/2012
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: mulroy, e. , quigley, g. , roberts, k. , cummins, g. , magennis, b. , fortune, g. , o'brien, d. , blunnie, w. P. , harrington, e. , gillivan-murphy, p. , kavanagh, e. , gilligan, p. , reilly r. , scola, p. , kelly, s. , murray, m. , lynch, t. Deep brain stimulation in ireland for parkinson's disease and essential tremor. The irish medical journal. 2012;105(8 ):11. Summary: deep brain stimulation (dbs) is highly effective neurosurgery for idiopathic parkinson's disease (ipd), essential tremor (et) and primary dystonia. Dbs involves stereotactic surgical implantation of a battery-operated stimulator into deep brain nuclei. (b)(6) patients are referred abroad for dbs and have to travel repeatedly for pre and post-operative care resulting in stress, anxiety and hardship. Safe pre and post-operative care of these complex, ageing patients is compromised by the absence of a dbs service in (b)(6). Moreover, both dbs surgery and the subsequent post-operative care abroad incurs substantial cost to the state. The (b)(6) institute at the (b)(6) university hospital ((b)(6)) is a non-profit institute for the care of patients with neurological diseases. The (b)(6) developed, in collaboration with the (b)(6) hospital and the (b)(6) centre, a dbs program in 2008/2009. We performed dbs at the (b)(6) campus on three carefully selected patients from a cohort of movement disorder patients attending the (b)(6) and continue to provide pre-operative assessment and post-operative care for patients following dbs in (b)(6) and abroad. Reported event: one year post dbs placement, the patient re-presented with recurrence of tremor and a feeling like "electric shocks" down his left arm due to dbs lead breakage. The shocks stopped once the dbs was switched off but his tremor reemerged. The patient was referred for repair, which was performed 9 months later. In the interim, he was again disabled by his severe essential tremor. He reports a significant improvement in his quality of life, activities of daily living and self-esteem post dbs. Further information has been requested; a supplemental report will be submitted if additional information is received.
 
Manufacturer Narrative

Product id neu_unknown_lead, serial# unknown, product type lead; product id neu_unknown_lead, serial# unknown, product type lead. (b)(4). The actual event dates were not provided. This date is based on the date of publication of the article.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2833108

« Last Edit: December 04, 2013, 05:49:31 AM by dennis100 » Logged
dennis100
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« Reply #17 on: November 06, 2013, 12:15:09 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/12/2012
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

Product id neu_unknown_lead, serial# unknown, product type lead. The actual event dates were not provided. This date is based on the date of publication of the article. (b)(4).
 
Event Description

Literature: baizabal carvallo, j. F. , mostile, g. , almaguer, m. , davidson, a. , simpson, r. , jankovic, j. Deep brain stimulation hardware complications in patients with movement disorders: risk factors and clinical correlations. Stereotactic and functional neurosurgery. 2012;90(5):300-306. Doi: 10. 1159/000338222. Summary: deep brain stimulation (dbs) has proven to be an effective treatment for parkinson's disease (pd) and other movement disorders, but its usefulness is limited by complications related to the hardware. We reviewed the records of all our patients treated with dbs from january 1996 to august 2010 and analyzed those with hardware complications and reasons for surgical revision. A total of 512 patients underwent 856 electrode implantations during the study period. A total of 297 (58%) patients had pd, 127 (24. 8%) had essential tremor (et), 40 (7. 8%) had dystonia, and 48 (9. 37%) had another movement disorder. The mean age at the first electrode implantation was 57. 6 +/- 14 years and patients were followed for a mean of 3. 9 8 2. 8 years. A total of 44 patients (8. 6%) had a hardware complication or system revision. Lead fracture was the most common complication and occurred in 13 (2. 5%) patients, followed by infections (n = 10, 1. 9%), electrode misplacement (n = 10, 1. 9%), electrode migration (n = 9, 1. 75%), and other complications (n = 2 , 0. 39%). Patients with et had a higher risk of hardware complications compared to those with pd, 13 vs. 7% (or 2. 03; p = 0. 042). Dbs is a safe intervention with a relatively low rate of hardware complications. Reported event: one patient with a lead fracture had bilateral vim deep brain stimulation (dbs) and was involved in a motor vehicle accident. Due to the accident the patient suffered whiplash neck trauma, complicated with cerebrospinal fluid (csf) leakage underneath the scalp and damage of the dbs system with secondary loss of stimulation effect, requiring surgical repair and system replacement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2862111
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« Reply #18 on: November 06, 2013, 12:15:59 AM »

Device Problems Break; Electromagnetic compatibility issue
Event Date 09/29/2010
Event Type  Injury   Patient Outcome  Hospitalization,Life Threatening,Required Intervention
Event Description

The pt has a long history of suicidal ideation and a number of suicide attempts prior to her enrollment in the original deep brain stimulation study for treatment of obsessive compulsive disorder. Treatment produced a nearly complete remission of her ocd symptoms. However, she has continued to struggle with recurrent depression, and depressive episodes have contributed to numerous hospitalizations for suicidal ideation during the course of her deep brain stimulation therapy. Discontinuation of therapy due to a lead break (on one occasion), end of battery life, or magnet exposure has contributed to some prior episodes. The pt was in a post-data collection phase, continuing therapy under a clause included in the original study protocol. The pt made a serous suicide attempt by overdose on previously prescribed and hoarded medications. At about 11:30 pm on (b)(6) 2010, she ingested over 100 tablets of ambien (10mg) and about 15 seroquel tablets (200mg). This attempt had been planned for many months, but was acutely precipitated by a traffic ticket for speeding and driving with an expired license (not renewed many months previously because of her plan to die). The guilt and embarrassment she anticipated in having to reveal this to her parents pushed her to take the overdose. The pt was taken from her parent's home to the hospital. She was treated with activated charcoal, sedated with propofol and subsequently weaned, with full recovery. She was then transferred to psychiatry service for safety and stabilization.
 
Manufacturer Narrative

(b)(4). The pt reports that she checked her stimulators a week or two before her attempt and they were functioning at that time. She does not believe they were switched off prior to the attempt. They were off when queried 2 days after the attempt, but the hour counts suggest that they had probably been off for only a short time, perhaps as a result of some magnet exposure during her extensive medical eval and intervention after the overdose. The hcp reported the suicide attempt was unrelated to deep brain stimulator therapy. Five days after the event, the pt reports full cognitive recovery and describes an 'epiphany' created by her survival and her faith, leading to full resolution of her suicidal intent and a new commitment to sustaining her life. She will remain hospitalized until her change of heart can be fully evaluated and consolidated, and her safety assured.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936101

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« Reply #19 on: November 06, 2013, 12:16:20 AM »

Model Number IPGNEURO
Device Problem Fracture
Event Date 12/16/2010
Event Type  Malfunction 
Manufacturer Narrative

(b)(4).
 
Event Description

The doctor tunneled the device from lead site to pocket site. The extensions were placed in the carriers and the doctor gently pulled back. The carriers then became lodged at what appeared to be about the level of c2 and broke off at the proximal end of the carriers. Extensions and carriers were lodged in neck and required excising. The integrity of the extensions was doubtful; therefore, a new set of extensions were re-tunneled. The pt was implanted without consequence and recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1952019
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dennis100
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« Reply #20 on: November 06, 2013, 12:16:41 AM »

Model Number IPGNEURO
Device Problems Fracture; Impedance issue
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Rec'd info the pt experienced a worsening of his motor symptoms. Lead impedances were abnormal and on x-ray the lead appeared fractured, about 1cm from the stimloc. It was planned to replace the lead in (b)(6), 2010. See previous mfr report 3007566237-2010-10471; this report should have been filed under a main device, an implantable neurostimulator. See also correction in section d for lead lot number and implant and explant dates of lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1956778
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dennis100
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« Reply #21 on: November 06, 2013, 12:17:02 AM »

Model Number IPGNEURO
Device Problems Coiled; Wire(s), breakage of
Event Date 09/22/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

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

Literature: burdick ap, okun ms, haq iu, et al. Prevalence of twiddler's syndrome as a cause of deep brain stimulation hardware failure. Stereotact funct neurosurg 2010;88(6):353-359. Summary: the authors reviewed their deep brain stimulation patient database to describe hardware complications which resulted from implantable pulse generator mobility, a phenomenon referred to as twiddler's syndrome. A prospectively collected database of adverse events for all center patients was queried searching for hardware malfunctions. Out of 362 total leads implanted in patients since 2002, 17 hardware malfunctions were identified. Among these 17 hardware malfunctions, 5 leads (in 3 patients) were identified after careful review to be twiddler's syndrome based on history, radiographic evidence and intraoperative findings during hardware revisions and are being reported in this article. Reportable event: a (b)(6) male had bilateral staged (3 months) ventralis intermedius nucleus dbs implantation. He weighed (b)(6) and was (b)(6) tall, giving him a body mass index of (b)(6). Within days of the placement of the second dbs system on his right side, he reported that he occasionally felt as though the ipg were standing perpendicularly within the pocket. He reported manipulating the ipg to relieve these sensations. One year after implantation of the first dbs system, he presented to the emergency room after awakening the night before with pain and swelling in his left posterior scalp. He reported that his scalp felt 'like a tube. ' it was presumed that the pain was due to pressure on the hardware during sleep, and he was prescribed anti-inflammatory medication and instructed to cushion the area at night. Five months later (17 months after implantation), his right-hand tremor recurred, and interrogation of the left ipg was unsuccessful (no contact could be established with the ipg for programming). Imaging was not obtained. He was diagnosed as having an ipg failure and taken to the operating room, and the left ipg was removed from the subcutaneous pocket and found to be very loose in the pocket. The extension cable was wound upon itself, fractured and completely severed 10 cm above the ipg. The ipg and extension cables were replaced. The pocket size was reduced by stitching the inferior and medial aspects and the ipg was anchored within the pocket. Three months following this revision, his left dbs system again failed. X-rays revealed kinking of the left intracranial lead 2 cm distal (superior) to the connection with the extension cable, and interrogation of the left ipg was not possible (again contact could not be made with the remote programmer). Interrogation of the right ipg showed normal impedances and current drain values for contacts 0 and 2 but high impedances and current drain contacts 1 and 3, suggesting a fracture within the lead. X-rays revealed the left extension cable had no evidence of twisting, but the right extension cable was moderately twisted. The patient felt that both ipgs were 'moving', especially when he lay supine, with the right ipg more problematic than his left. He was taken to the operating room and both ipg pockets were explored. The previously revised left ipg was immobile within the pocket and remained in the correct orientation. However, it still could not be remotely interrogated. The right ipg pocket was noted to be lax, and the ipg could be rotated within it. No tension was encountered in either extension cable. A new ipg was placed into the left chest pocket, and both ipgs were anchored securely. See literature article with mfr report# 3007566237-2011-02085.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2028319

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dennis100
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« Reply #22 on: November 06, 2013, 12:17:30 AM »

Model Number UNKNOWN
Device Problem High impedance
Event Date 06/08/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the patient experienced a return of symptoms. At a follow-up impedance, measurements were >4000. A revision procedure was performed, during which the lead was disconnected from the extension and connected to an external neurostimulator. The impedance measurements confirmed impedances >4000 on all electrode pairs. It was noted that probably during the disconnection of the lead, the remaining intact conductors were damaged. The lead was replaced. Following surgery, the patient was reported to be "okay. ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2159285

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dennis100
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« Reply #23 on: November 06, 2013, 12:17:52 AM »

Device Problem Device operates differently than expected
Event Date 06/10/2011
Event Type  Malfunction 
Event Description

It was reported that the physician had "multiple failures" of the lead cap when attaching and/or detaching it from the proximal end of the lead, between the first- and second-stage procedures. The metal housing for the grub screw rotated within the silicon body of the lead cap, and was too small to hold effectively. This resulted in "obvious damage" to the lead on several occasions. The leads were not replaced. There was no injury to the pt. The pt recovered without sequela. A follow-up report will be filed if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2182200

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dennis100
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« Reply #24 on: November 06, 2013, 12:18:18 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/01/2011
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: slavin kv. Technical aspects of peripheral nerve stimulation: hardware and complications. Prog neurol surg. 2011;24:189-202. Summary: the authors report on peripheral nerve stimulation complications seen since (b)(6) 2000. They reviewed 40 pts with pns implants who were followed for longer than 30 months. Reportable event: the authors report one revision due to lead erosion 4 weeks after implantation. See literature article with mfr report# 3007566237-2011-05208.
 
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 additional info was available, additional info regarding the pt, event, intentions and outcome has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2160845
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dennis100
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« Reply #25 on: November 06, 2013, 12:18:42 AM »

Model Number UNKNOWN
Device Problem Fracture
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that the pt visited the physician due to the return of symptoms. The pt was reprogrammed and an x-ray was performed. There was "some breakage" found at the proximal end of the lead. An explant and replacement of the lead was performed during the week of (b)(6) 2011. The pt, then, received "proper" therapy. There was no injury to the pt.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2160651

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dennis100
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« Reply #26 on: November 06, 2013, 12:19:10 AM »

Model Number IPGNEURO
Device Problem Break
Event Date 10/02/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time, no add'l info was available, add'l info regarding the pt, event, interventions and outcome has been requested.
 
Event Description

Literature: halim a, baumgartner l, binder dk. Effect of deep brain stimulation on autonomic dysfunction in pts with parkinson's disease. J clin neurosci. Jun 2011; 18(6):804-806. (b)(6). Summary: the authors examined the effects of subthalamic nucleus (stn) deep brain stimulation (dbs) on autonomic symptoms (sweating, bladder, or bowel function); they examined 11 pts undergoing stn dbs for parkinson disease. Reportable event: the authors report on a (b)(6), right-handed, male (pt (b)(6)). His age of onset of pd was (b)(6). He underwent unilateral left stn-dbs surgery at the age of (b)(6) for motor function control of his right hand. The pt was "slightly dissatisfied" with his bladder condition before surgery and reported occasional urgency to urinate, difficulty with excreting urine, and urine leaking unwittingly while awake and asleep. Post-operatively, the pt was "satisfied" with his bladder condition. He reported having significant, symmetric sweating problems pre-operatively that worsened during the day and was worse when "off" medication. Post-operatively, he did not experience any sweating problems. His bilateral sweating problem resolved completely even with unilateral stn stimulation. The pt required a revision to replace the left stn electrode due to a lead fracture, his sweating problem resumed until the electrode was replaced and the pulse generator was turned back on, at which time the sweating problem again resolved immediately.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2161802
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dennis100
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« Reply #27 on: November 06, 2013, 12:19:34 AM »

Model Number IPGNEURO
Device Problem High impedance
Event Date 06/22/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

It was reported that there was a return of symptoms during the last four months. The hcp believed that it was due to the fact that only one lead had been implanted, so they decided to implant a new lead on the other side to obtain bilateral stimulation. At the moment of the procedure it was noticed that the lead already implanted presented an interruption of the conductions (they seemed to be broken) just before the connection with the extension. The impedances reported were>4000. Add'l info has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2169553

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dennis100
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« Reply #28 on: November 06, 2013, 12:19:56 AM »

Device Problem Connection issue
Event Date 06/22/2011
Event Type  Malfunction 
Event Description

It was reported that the pt's physician suspected that the base of the lead underwent a "deflection" due to the shape of the pt's skull. Thus, the base of the lead was bent "a little," and the support clip did not fit the base of the lead. Another lead was used to complete the procedure. There was "no health hazard" to the pt and no further issue was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2196661
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dennis100
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« Reply #29 on: November 06, 2013, 12:20:19 AM »

Model Number 37601
Device Problem Fracture
Event Date 01/01/2011
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that the pt had a fall several months ago, sustaining a blow to the head at the connection of the leads and extension. The pt subsequently received no therapeutic effect from the left lead. Impedance tests revealed that all of the electrodes were out of range, at all voltages on the left lead. X-ray indicated a left lead fracture, at the tip of the boot. The right lead appeared to be stretched, but was electrically intact and remained implanted. The left lead was removed and replaced. There was no pt injury and the pt recovered without sequela.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2193697

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