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Author Topic: Deep brain stimulator - Arms  (Read 52317 times)
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dennis100
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« Reply #60 on: January 17, 2014, 10:28:36 PM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 02/01/2009
Event Type  Injury 
Event Description
The pt was shutting the back window of her car when she received a shock that traveled from her right hand, down her arm, across her chest, to her left arm. The pt was seen by her hcp. Impedances were normal. There was no power on reset. Therapeutic results were fine. Please see mfr. Report# 3004209178200901805. 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=1344064
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dennis100
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« Reply #61 on: January 17, 2014, 10:29:46 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/01/2009
Event Type  Malfunction 
Event Description
It was reported the patient fell and hit her head a couple of days prior and since then has felt "tingles" in her right arm. Described as a "buzzing. " additional information was requested.

 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1395022
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dennis100
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« Reply #62 on: January 18, 2014, 04:02:52 AM »

Model Number 7428
Device Problems Extraneous radiofrequency wave transmission; Replace; Inappropriate shock; Implant, reprogramming of
Event Date 12/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient experienced worsened tremor. The deep brain stimulator was replaced due to battery depletion. At the clinic visit 1 week after device replacement, the pt experienced improved gait and slightly improved tremor control. The pulse width was increased resulting in complete tremor control to the left side of body. Mild to moderate tremor persisted in the right upper limb and occasionally right leg. The patient experienced right shoulder pain. The patient was treated with ropinirole xl and sinemet. At a clinic visit approximately 1 month later, the patient felt shocking when the device was turned on at an amplitude of 4. 0 volts. Impedances were greater than 4000 ohms on electrode combinations involving electrode #3. The tremor was well controlled at 4. 8 volts, but the patient had deteriorated, slurred speech. Therapy amplitude of 5. 7 volts controlled tremor, but caused right-sided tingling and increased slurring of speech. The pt experienced slight right-sided tingling at 4. 7 volts. At 5. 2 volts, the patient felt slight numbness to the left leg. The ropinirole caused facial dyskinesias. The device was reprogrammed to previous settings (as they were prior to generator replacement). The patient had better tremor control on the right body side on lower settings. The patient's postural stability was similar to that before increasing the settings. The patient's speech was less slurred, but slow at times. The patient ambulated with slow, small steps. The patient's condition was not able to be stabilized with reprogramming. The deep brain stimulator was replaced (b)(6) 2009. The patient was doing well with the new stimulator at the original settings. The nurse mentioned that there was.

 
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1370871
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dennis100
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« Reply #63 on: January 18, 2014, 04:09:09 AM »

Model Number 7426
Device Problems Device remains implanted; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 01/01/2009
Event Type  Malfunction 
Event Description
It was reported that the patient experienced "tingling down his right arm" when cautery used on the left side of the patient's face. Additional information has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1428959
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dennis100
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« Reply #64 on: January 18, 2014, 04:10:25 AM »

Model Number 7426
Device Problems Lead(s), breakage of; Migration of device or device component; Implant, reprogramming of
Event Date 11/01/2008
Event Type  Malfunction 
Event Description
It was reported that the patient experienced chest pain in the middle and right side of the chest while the stimulation was turned, when the physician increased the pulse rate from 4. 5 to 4. 8. The pain subsided when the stimulation was turned off. The voltage was decreased on the left side. The patient was seen a week later, and reported pain in the right side of the back in the thoracic area. No changes to programming were noted. A week later, the patient had a botox injection, which resulted in less pain. The patient reported no "seizure-like episodes". No changes were made. Two weeks later, the patient noted painful contractions in the left forearm and left foot. No changes were made to programming. The patient was going into swimming courses. Several months later, it was reported that the entire system was scheduled to be replaced. X-rays revealed that the connector had been pulled down approximately 3 inches from behind the ear into the next region, and the lead was fractured and there were problems with the impedances. No patient outcome was reported. Reference manufacturer's report #3004209178200903788.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1458863
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dennis100
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« Reply #65 on: January 18, 2014, 01:51:45 PM »

Model Number 7426
Device Problem Replace
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient experienced a loss of therapeutic effect with return of symptoms (tremor of the right hand and arm). The patient was unable to adjust stimulation with their patient programmer or with one sent by loaner/repair. Patient commented on end of life of their implantable neurostimulator. Additional information received reported that the patient underwent a surgical revision of their implantable neurostimulator and was no longer experiencing stimulation problems.

 Manufacturer Narrative
The patient programmer was returned for analysis/repair. The device tested according to specifications. There was no anomaly found. The implantable neurostimulator was not returned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1387040
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dennis100
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« Reply #66 on: January 18, 2014, 01:53:17 PM »

Model Number 7426
Device Problems Intermittent continuity; Implant, reprogramming of
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 Event Description
See mfr# 3004209178200903254. It was originally reported that the pt thought her device was not working and that she was feeling horrible. She does not have a pt programmer. Every time her device was reprogrammed her hips hurt, arms get stiff and she shakes. These symptoms last for several days. The pt felt that her device has never really helped her. It was later reported that her right hand "turns inside out" and it gives her hip problems. She does not know if this was the case of prior to turning stimulation, due to her shaking so much without stimulation. She does have some symptom relief. Her device has been reprogrammed. The pt's device kept turning off. She still does not have a pt programmer. She was still having issues with her device system. Further info is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1458573
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dennis100
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« Reply #67 on: January 19, 2014, 12:11:14 AM »

Model Number IPGNEURO
Device Problem Implant, reprogramming of
Event Date 12/01/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
The pt fell off a bike and injured his right shoulder. Following the fall, the pt experienced a loss of therapeutic effect. The pt's tremor symptoms in his right arm seemed to have worsened and were not getting better with adjustments. The pt also experienced increased pain; the pt had torn his left rotator cup before and the pain after the fall felt like that. The physician wanted to do an mri, but the pt advised him that he couldn't have an mri. After the most recent reprogramming session, it was reported that the pt was getting good relief. The pt was at home. The pt planned to have the device checked by a healthcare professional. Additional info has been requested, a follow-up report will be sent if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1427974
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dennis100
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« Reply #68 on: January 19, 2014, 12:11:51 AM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 03/01/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
The pt fell about a month ago and fractured his hip; the pt was going through medical treatment for the fracture. Following the fall, the pt experienced a loss of therapeutic effect. The pt had more tremors since 2009, especially in his right arm. His left arm normally didn't tremor as much, but was shaking more than usual. The pt was at home. Additional info has been requested, a follow-up report will be sent if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1427975
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dennis100
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« Reply #69 on: January 19, 2014, 12:12:21 AM »

Model Number 7426
Device Problems Loss of power; Suspect EMI
Event Date 04/12/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4). This report is being filed following an internal audit.

 
Event Description
It was reported that while the patient was on the cordless phone, the right side device turned off. The patient also experienced spasms in her right arm. The patient stated the device was not working. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1475687
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dennis100
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« Reply #70 on: January 19, 2014, 12:39:50 AM »

Model Number 7426
Device Problems Inappropriate shock; Implant, reprogramming of
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a lack of therapeutic effect since the time of the implant and felt the symptoms had gotten worse over the past month. The patient symptoms were; dizziness, balance issues, trouble with speech, walking, has stiffness/rigidity, double vision, freezing constantly, weakness, and fatigue. The patient did note that he had been dizzy for the past two years. The patient stated the tremors in the right arm were worse now than before implant. The patient reported a shocking or jolting sensation every time he turned on his "lower: ipg. This resulted in a headache and "racing of heart". The device was turned off and the symptoms were gone about 2 hours later, but the patient's tremors in his right hand returned. Multiple attempts at reprogramming had been unsuccessful and the patient was requesting the leads to be explanted. Please see mfr. Report# 3004209178200904365. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1407420
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dennis100
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« Reply #71 on: January 19, 2014, 04:35:16 PM »

Model Number 7426
Device Problems Lead(s), breakage of; Replace
Event Date 05/18/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported, the patient experienced right sided tingling down the neck and arm. The extension was revised. Upon inspection during the revision, the distal end of the brain lead looked damaged with compromised insulation. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

 
Manufacturer Narrative
The device has been returned to the manufacturer for analysis, which is not complete as of the date of this report. A follow-up report will be sent when the analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1403241
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dennis100
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« Reply #72 on: January 19, 2014, 04:35:57 PM »

Model Number 7428
Device Problem Inappropriate shock
Event Date 07/01/2009
Event Type  Injury 
Manufacturer Narrative
 
Event Description
It was reported the patient experienced a shocking or jolting sensation randomly in her arm and leg. She additionally reported some pulling sensations that lasted for a few seconds and then goes away. The symptoms have occurred in the bathroom, at the dining table and in a restaurant. There was no correlation between the patient's positions and the symptoms. No further outcome was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1463139
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dennis100
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« Reply #73 on: January 19, 2014, 04:36:44 PM »

Model Number 37612
Device Problem No Information
Event Type  Malfunction 
Event Description
It was reported that the pt's leg went out on them and they fell and hit their head while throwing something over a chair. This was followed by a drawer falling on them. It was also reported that the pt experienced cramping in their torso, arm, hands, and knees to toes. The cramps were alleviated with walking around. The pt had a history of blood clots. Additional info has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1494706
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dennis100
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« Reply #74 on: January 19, 2014, 04:37:48 PM »

Model Number 7428
Device Problem Inappropriate shock
Event Date 07/01/2009
Event Type  Malfunction 
Event Description
The pt experienced a shocking or jolting sensation over the neck area and down his arm. The pt turned the device off until he could be seen by a physician to determine what was going on. Additional info has been requested, a follow-up report will be sent if additional info becomes available.

 
Manufacturer Narrative
(b) (4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1492124
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dennis100
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« Reply #75 on: January 19, 2014, 04:39:09 PM »

Model Number 7428
Device Problem Loss of power
Event Date 07/06/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that the pt woke up feeling "funny". The implantable neurostimulator was found to be off. The implantable neurostimulator was turned back on, however, the symptoms worsened. When stimulation was on, the pt reported a "stronger sensation" than usual. The symptoms began in the pt's arm. There was no known incident related to the event. Additional info has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1485136
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dennis100
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« Reply #76 on: January 20, 2014, 01:04:41 AM »

Model Number 7426
Device Problems High impedance; Inappropriate shock; Low impedance
Event Type  Malfunction 
Event Description
It was reported that the pt experienced a shocking sensation on the left side of their face which travels into hand and arm. The symptoms appeared following a tooth extraction on the right side of the pt's mouth. High and low impedances were reported. Impedances: c/0 >2000 8ua, c/1>2000 9ua, c/2 669 19, c/3 678 19 all bipolar pairs <50 and 223. Programmed c+1-, 2. 6v, 60 185.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1463155
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dennis100
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« Reply #77 on: January 22, 2014, 07:10:30 AM »

Model Number IPGNEURO
Device Problem No Information
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient wished she never had the implant. She had an "air bubble" and "the skin separated from the bones". She had pain in the radial nerve of her left arm and the device made it, so her eyes could not open. The device has since been explanted. Further info is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1590191
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« Reply #78 on: January 25, 2014, 03:41:26 PM »

Model Number 7426
Device Problem No Information
Event Date 08/01/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that while pt was having a biopsy on the left temple (same side as lead -- left stn), the pt felt a tingling down the right arm. Once the cautery stopped, the tingling subsided. The biopsy indicated that further treatment was necessary. It was recommend that radiation would be a better choice and the radiation beam should be directed away from the device. Additional information 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=1834607
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« Reply #79 on: January 25, 2014, 03:41:53 PM »

Model Number 7426
Device Problem High impedance
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).

 
Event Description
The impedance measurements were greater than 2000 ohms on all of the unipolar pairs. The patient experienced a tingle sensation in opposite hand/arm when the neurostimulator was on. Further information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1831835
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« Reply #80 on: January 26, 2014, 01:51:30 AM »

Model Number 7428
Device Problem Inappropriate shock
Event Date 06/01/2010
Event Type  Malfunction 
Event Description
It was reported, the patient experienced a shocking or jolting sensation down the left arm. It was stated, the impedances on the patient's device "changed when the doctor reran the impedance test. " the possibility of a fluid short was discussed. The patient's information was not reported. Additional information has been requested, a follow-up report will be sent if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885252
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« Reply #81 on: January 27, 2014, 08:44:32 AM »

Model Number 7426
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that after replacement the symptom was not improved. It was noted that now the patient was in the hospital. Additional information received reported that the patient did not clarify the device. It was noted that the patient was in the hospital for further observation and they would discuss with the hospital for programming. It was noted that the patient¿s limb and tongue stiffness was aggravated. It was noted that the left body tremble was aggravated.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528574
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dennis100
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« Reply #82 on: January 27, 2014, 08:45:35 AM »

Model Number 7426
Event Date 01/24/2007
Event Type  Injury   Patient Outcome  Other,Required Intervention,Hospitalization
Manufacturer Narrative
Product id 3389s-40 lot# v013803, implanted: 2007 (b)(6); product type lead product id 3389s-40 lot# v014891, implanted: 2007 (b)(6); product type lead product id 7482a51 lot# serial# (b)(4); product type extension product id 7482a51, serial# (b)(4); product type extension product id 7426, serial# (b)(4); product type implantable neurostimulator. (b)(4).

 
Event Description
It was reported that the patient had left basal ganglia infarct during implant surgery. Post-operatively, the patient had mild right arm and facial weakness, and the follow-up ct scan of the brain noted a left basal ganglia lacunar infarct. During the patient¿s time in the hospital, he had post-operative confusion which slowly resolved. His facial weakness and arm weakness completely resolved without sequelae. ¿other¿ intervention occurred. It was resolved as of (b)(6) 2007. See mfr report numbers 2182207-2007-00690 and 2182207-2007-00689 for previously reported information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3531162
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« Reply #83 on: January 27, 2014, 08:46:54 AM »

Model Number 37601
Event Date 07/08/2013
Event Type  Injury   Patient Outcome  Disability
Manufacturer Narrative
Product id 3389s-40 lot# va07vdx, implanted: 2013 (b)(6); product type lead product id 3389s-40 lot# va07vdx, implanted: 2013 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension. (b)(4).

 
Event Description
It was reported, the patient was regressing and their symptoms returned the night prior to this report. It was noted, the patient had an appointment with their healthcare professional on the day of this report. The reporter stated, the patient was adjusted yesterday afternoon and was okay for an hour and then they started to decline until they were completely disabled. It was noted the patient was complaining of symptoms behind their right ear and their arm. It was further noted the patient felt tightening that had improved in their arm, but not behind the ear. The reporter stated the patient had anxiety about their symptoms and they could not move. It was noted the patient was not able to adjust stimulation. It was noted the patient programmer showed a synchronize patient programmer and implantable neurostimulator warning screen. It was further noted the patient placed the antenna over the implant, pressed the sync key, and the warning screen went away. 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=3528240
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« Reply #84 on: January 28, 2014, 09:51:23 AM »

Model Number 7428
Device Problem Break
Event Date 10/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: cacciola f, farah jo, eldridge pr, byrne p, varma tk. Bilateral deep brain stimulation for cervical dystonia: long-term outcome in a series of 10 pts. Neurosurgery. Oct 2010;67(4):957-963. Summary: the authors reported on the long-term outcome of their pts with bilateral gpi deep brain stimulation in cervical dystonia. Ten consecutive pts from february 2002 to august 2008 were followed; their mean age was 52. 2 years. On the total twstrs score, an overall improvement was seen; three pts had excellent improvement, 4 were good and 3 were moderate. On the severity subscale score, all pts were classified as responders with a mean improvement of 66. 6%. Three had excellent, 5 good, and 2 moderate improvements. On the pain subscale score, all but 1 pt responded to treatment, with a mean improvement of 58. 3%. Five had excellent, 1 good, and 3 moderate improvement, whereas 1 pt failed to respond. On the disability subscale score, all pts responded with a mean improvement of 80. 7%. Seven had excellent, 2 good, and 1 moderate improvement. Three complications were reported. Reportable event: this report is for one pt who experienced a lead breakage. The lead breakage occurred 1 year after initial placement, resulting in a partial return of the torticollis and mainly the sensation of electrical surges, as reported by the pt from the neck down into the right arm. The electrode was subsequently replaced.

 
Manufacturer Narrative
(b)(4) (no code): torticollis (yes). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time, no additional information was available, additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1913949
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« Reply #85 on: February 07, 2014, 08:31:15 AM »


Model Number NEU_INS_STIMULATOR
Event Date 09/04/2012
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization,Disability
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, lot# unknown product type: lead. Product id: neu_unknown_ext, lot# unknown product type: extension. (b)(4).

 
Event Description
It was reported there was a concomitant left basal ganglia intracerebral hemorrhage (1 x 2cm) that surrounded the left deep brain stimulation (dbs) lead. It was noted intervention included medical or non-surgical therapy. It was stated there was a ct scan without contrast. It was noted the results were expected post-operative pneumocephalus and no new hemorrhage was identified on (b)(6) 2012. It was noted on (b)(6) 2012 another ct scan without contrast was performed and the hemorrhage around the tip of the left dbs was unchanged. It was stated an eeg was performed and the results were independent right and left frontotemporal irregular delta slowing, frontal intermittent rhythmic delta activity which was suggestive of a mild to moderate non-specific cerebral dysfunction on (b)(6) 2012. It was noted an eeg with video suggested dysfunction in the left hemisphere. It was stated on (b)(6) 2012 a ct scan without contrast was performed and the results showed the pneumocephalus had resolved and there was a continued evolution of intraparenchymal hemorrhage that was centered around the left dbs lead and no hemorrhage was seen. Etiology consisted of surgery and anesthesia. It was noted it was not related to the device or therapy but it was possibly related to the implant procedure. It was noted the patient had weakness on right upper extremity and aphasia with a decline in respiratory rate and it was severe. It was noted the event resulted in in-patient hospitalization and prolonged existing hospitalization and persistent or significant disability/incapacity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3591800
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« Reply #86 on: March 29, 2014, 12:04:41 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the patient was extremely uncomfortable with the implantable neurostimulator (ins). The ins did not seem very suitable for her. It was very large and she was very skinny. She had pain in the muscles of the left side of chest right above the breast and she could not use her arm properly. She had a lot of pain in her chest. It was ¿kind of like¿ contracting her muscles when she moved her arm in certain positions. Eating and ¿stuff¿ would cause the muscle to contract and pain. The patient did not feel this uncomfortable with the last ins. It was very difficult for her and she could not eat. The patient was going to talk to her health care professional on (b)(6) 2012. Additional information received reported there was ¿very little¿ the health care professional could do to make the patient more comfortable. It was later reported that the patient¿s first operation was in (b)(6) 2012 and she had had a single ¿big battery¿ implanted but it was too big and coming out of her chest. The patient was slender. Patient had her second operation in (b)(6) 2013 and that was when 2 smaller batteries were put in her chest. It was noted that after this surgery everything was fine. Patient had devices check in (b)(6) 2013 and everything was fine then too.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3640480
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dennis100
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« Reply #87 on: March 29, 2014, 12:05:27 AM »

Model Number 7428
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient was implanted on (b)(6) 2008 due to dystonia. In (b)(6) 2013, the patient had gone to the hospital for programming. It was noted that the patient was told that the product could remain for only 4-6 months. In (b)(6) 2014, the patient had experienced arm numbness and difficulty opening eyes. Additional information received reported the reason for the patient symptoms was unknown and it was unobtainable whether they were related to a device malfunction. It was unobtainable whether this was expected/normal or premature battery depletion. Patient¿s family was considering replacing the product. It was unobtainable whether patient would have replacement of their system. Additional information received reported that the patient was planning to have a replacement operation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3649772
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dennis100
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« Reply #88 on: April 10, 2014, 08:20:05 AM »

Model Number 37603
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
It was originally reported on (b)(6) 2014 that the patient had a hematoma and a patient injury. It was noted a week prior to report the patient had woken up with a neck ache and they went ¿downhill from that point. ¿ it was stated the patient had an injury and they had gone to see their doctor about one month prior to report because of headaches on the side of their head where the leads were. It was stated the patient had a concussion at that time. It was noted the concussion was caused by a fall in their bedroom where the patient had hit their head. It was stated the patient had 3 concussions in their life because they were ¿sort of a klutz¿ and they had fallen recently. It was noted the patient had been hospitalized ¿on a couple of occasions because when they would hit their head their forehead would swell and it was insane. ¿ it was noted the patient might have had a bit of blood there and that¿s why they had headaches. It was stated they may have had a little subdural hematoma that would have created the pain from the leads. Two days later it was reported that the patient was staying at the clinic¿s hotel for the outpatient program at the time of the report. The reporter stated that after implant everything was fantastic and all of her symptoms went away, maybe 95% of them, but then all of a sudden last week they all came back in a 24 hour period and got progressively worse. The patient went to the doctor to reprogram the device ¿on friday and today. ¿ the reporter noted that at previous reprogramming sessions the patient could always feel the doctor reprogramming, such as her arm jerking if it got too high or feeling it in her tongue which would go away, but this time she felt nothing. The doctor tried twice to reprogram it. The reporter noted that the patient had to go in for reprogramming every two months to ¿tweek¿ it a little bit. The reporter stated that they seemed to believe the device was working, they had no reason to believe otherwise, except none of them had seen it come back so fast in such a short time. The reporter stated that ¿something was odd when something stopped working immediately. ¿ the reporter stated that ¿after seven months of absolute perfect to have it all go to hell in one day, something was not right there. ¿ the reporter was assuming that something went wrong or the battery went out or it got turned off. The doctor reportedly told the reporter that the device was working. The patient still had ¿full symptoms going. ¿ the reporter was not sure if they had tested system integrity or not and did not know if they were getting any messages on the patient programmer. The reporter stated that the patient was also in excruciating pain, all within 24 hours. The patient had a concussion two weeks prior to the report. The patient hit her head against the wall, but had no symptoms at that time. The reporter stated that the implantable neurostimulator (ins) was ¿way off to the side, so they could not really set it and it was bugging the hell out of the patient. ¿ the patient was playing with the ins all of the time and trying to make it feel better. The patient pushed the ins from side to side because it ¿kind of rubs against the bone. ¿ the reporter stated that the doctor said the only way to change it was when the ins was changed out the next time. The doctor had not done any x-rays or anything. The reporter was going to talk to the doctor the day after the report. 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=3677018
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dennis100
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« Reply #89 on: April 10, 2014, 08:21:37 AM »

Model Number 37612
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient had increased stimulation and ¿side effects¿ after going through a theft detector at a drug store. The following day, it was reported that the patient didn¿t have any problem with therapy until (b)(6) 2013, when the patient went through the theft detector. The patient started to feel shocks in his left arm and had blurred vision the day after. Additionally, the battery was checked with the patient programmer which showed a call-your-doctor icon. After recharging the battery to 100%, the shocks ceased. The following morning, the battery had completely run down. It was recharged again and reset by the healthcare provider (hcp) but the shocks continued. Since then, ¿satisfactory results in the treatment was no longer obtained¿. On (b)(6) 2014, after several attempts, it was possible to set the device to obtain the therapeutic results prior to the theft detector incident. Five days after that however, a call-your-doctor icon was displayed again. The patient also started to feel shocks in his left arm and the battery started to run down quickly. The device was reprogrammed twice after that but that did not ultimately remedy the situation. Stimulation was subsequently turned off. The reporter believed that ¿the device was not supporting amplitude pulses greater than 3v since there was discharge and the need to turn the device off and reduce the amplitude¿. Four days later, it was reported that the patient was charging more than expected. The message that accompanied the call-your-doctor icon could not be recalled. It was further reported that the patient also started feeling tingling in his arm after going through the theft detector. It was unknown if it was a power-on-reset (por) that was displayed along with the call-your-doctor icon. The device reportedly discharged within a day and the patient believed there was a ¿failure¿ with it. Diagnostic testing performed on (b)(6) 2014 showed the typical recharge duration was 0. 5 hours and the typical recharge interval was 0 days and the implantable neurostimulator (ins) status was ok. Similar testing done approximately a week later indicated that the typical recharge duration was 0. 4 hours and the typical recharge interval was 0. 2 days. It was also noted that stimulation was off. Cycling had been off in both cases and the patient had been programmed to 0+,1+,2-,3+ and 8+,9-,10-,11+ on the left and right globus pallidus (gpi) respectively. No information on coupling was provided for both tests. There were no out-of-range impedances found. The charge percentage at the end of recharge sessions varied, but were not always 100%. Approximately two weeks later, it was reported that a ¿malfunction¿ was observed but the cause of the issue was not determined. Telemetry was performed and information pertaining to that diagnostic testing was pending. Surgery was going to be performed, details related to this of which were unknown at the time. The patient was not receiving effective therapy. If additional information becomes available, a follow-up report will be submitted.

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