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Author Topic: Deep brain stimulator - Stroke  (Read 29781 times)
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dennis100
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« Reply #30 on: January 25, 2014, 02:50:14 PM »

Model Number 37612
Device Problem No Known Device Problem
Event Date 07/21/2010
Event Type  Injury   Patient Outcome  Hospitalization,Other
Manufacturer Narrative
(b)(4).

Event Description
Right caudate ischemic event. On (b)(6) 2010, pt had implantation of bilateral dbs for dystonia. In the operating room, it was noted she had slight left sided facial weakness. Post-op mri revealed no acute abnormalities. A small abnormality was seen in right caudate head on diffusion imaging by the dbs team, not noted by radiologist. On (b)(6) 2010, mri was repeated due to facial weakness and flat affect. This mri shows right caudate had ischemia. On (b)(6) 2010, symptoms improved, decrease in left facial weakness, smiling, back to prior alertness and personality. On (b)(6) 2010, she was discharged to home after rapid improvement in her affect and facial weakness. She had evaluations from pt, ot and speech therapy in the hospital and will be scheduled for outpatient therapy if needed.

Manufacturer Narrative
(b)(4).

 
Event Description
Additional information received reported that the patient was in a motor vehicle accident after discharge. The patient returned to the hospital and it was noted that left facial weakness and somnolence remained from the initial post-operative stroke. It was reported that the patient experienced rapid improvement. On (b)(6) 2010 staring spells were noted. The patient was taken off lortab for 24 hours with no difference to staring spells. An electroencephalogram was performed, and the results were reported as abnormal, with some bifrontal sharp waves that might be suggestive of a possible tendency towards seizures. The patient was discharged the following day. On (b)(6) 2010 the patient underwent a ct scan and it was reported that there was no acute intracranial abnormality demonstrated. It was noted that the dbs wires were in unchanged position.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1888046
« Last Edit: February 07, 2015, 11:40:11 AM by dennis100 » Logged
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« Reply #31 on: January 25, 2014, 02:51:40 PM »

Model Number 7426 NEUROSTIMULATOR
Event Date 07/14/2010
Event Type  Injury  
Patient Outcome  Other
Event Description
Stroke surrounding the right sided stimulator. On (b)(6) 2010, pt had implantation of bilateral dbs for dystonia. Upon awakening the evening of surgery, the pt experienced facial drooping and problems with understanding her speech. On (b)(6) 2010, symptoms continued and she progressively had problems with putting sentences together, talking very slowly, and had difficulty understanding what was being said to her. On (b)(6) 2010, she developed left hemiparesis. Pt was transferred to rehab unit on (b)(6) 2010 and discharged home with mother on (b)(6) 2010. Upon discharge, pt was full transfer alone and one handheld assist with gait due to impulsivity and poor motor planning. Clinically, pt was nearly back to baseline. Pt will be scheduled for outpatient therapy if needed. F/u info 07/27/2010: all motor symptoms from stroke have resolved. Family reports cognition is at baseline and possibly better than prior to implants.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1913087
« Last Edit: February 07, 2015, 11:40:40 AM by dennis100 » Logged
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« Reply #32 on: January 26, 2014, 01:42:48 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
« Last Edit: February 07, 2015, 11:41:26 AM by dennis100 » Logged
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« Reply #33 on: January 27, 2014, 02:44:51 AM »

Model Number 3389S-40
Event Date 11/14/2013
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # va0amdm, implanted: (b)(6) 2013, product type lead. (b)(4).

Event Description
It was reported that the patient was in the emergency room with a possible stroke. It was stated that it was unrelated to the system. The physician wanted to do an mri. The patient had their leads placed 9 days prior for the partial implant and the stimulator had not yet been placed. Additional information was requested, if received, a follow up report will be sent.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3499603
« Last Edit: February 07, 2015, 11:41:50 AM by dennis100 » Logged
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« Reply #34 on: January 27, 2014, 08:59:50 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
« Last Edit: February 07, 2015, 11:42:22 AM by dennis100 » Logged
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« Reply #35 on: January 27, 2014, 10:12:36 AM »

Model Number 37612
Event Date 12/04/2013
Event Type  Injury  
Patient Outcome  Hospitalization
Manufacturer Narrative
Product id: 37642, serial# (b)(4), implanted: (b)(6) 2010, product type: programmer. Patient product id: 37651, serial# (b)(4), implanted: (b)(6) 2010, product type: recharger. Product id: 64002, lot# n245317, implanted: (b)(6) 2010, product type: adapter. Product id: 3389-40, lot# j0320167v, implanted: (b)(6) 2004, product type: lead. Product id: 3389-40, lot# j0421486v, implanted: (b)(6) 2004, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. (b)(4).

Event Description
It was reported that the patient went to the hospital for a possible stroke. It was noted that the patient was doing better at the time of the report. Additional information received reported that the patient received assistance from the manufacturing representative and their concerns were resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3544959
« Last Edit: February 07, 2015, 11:42:49 AM by dennis100 » Logged
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« Reply #36 on: January 28, 2014, 09:13:09 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 01/01/2010
Event Type  Injury  
Patient Outcome  Other
Event Description
The hcp noted an area of hypodensity in a pt treated with deep brain stimulation. He was in the process of evaluating the event as a possible stroke. 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=1946759
« Last Edit: February 07, 2015, 11:43:15 AM by dennis100 » Logged
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« Reply #37 on: February 06, 2014, 11:11:28 PM »

Model Number 7426
Event Date 05/06/2004
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
Product id 3387-40, lot# j0107975v, implanted: 2001 (b)(6); product type lead product id 7495-25, serial# (b)(4), implanted: 2001 (b)(6); product type extension. (b)(4).

Event Description
It was reported, the patient had a stroke on the table during their second implant on (b)(6) 2004 and another stroke 6 months later. It was reported, the patient came out of them "pretty good but had a lot of weakness".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3600340
« Last Edit: February 07, 2015, 11:43:42 AM by dennis100 » Logged
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« Reply #38 on: February 07, 2014, 12:21:28 AM »

Model Number 37612
Event Date 12/31/2013
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
Product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# va0a55s, implanted: 2013 (b)(6); product type lead product id 3387s-40, lot# va0a55s, implanted: 2013 (b)(6); product type lead 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 had one side of the deep brain stimulator (dbs) turned on 2013 (b)(6) and the patient was doing ¿very very well¿ and they could understand when the patient talked and the patient could talk perfectly. It was stated, the patient¿s second side was turned on 9 days prior to report and ever since then the patient had problems. It was noted, the patient was stumbling and they used a walker to help them and they had an awful time navigating. It was stated, the patient would babble. It was noted it was hard to understand the patient. It was stated, the patient would babble and it ¿was like the patient had a stroke. ¿ it was stated they did not think the patient had a stroke. It was stated when the second side was turned on the patient fell at the health care professional¿s office. It was stated, the patient was weak and falling again. It was noted, the stimulation was turned down until the patient felt better and steadier on their feet and would not stumble. It was noted, the patient programmer did not have the ability to increase stimulation but only decrease. It was further reported, the cause of the event was possible effect of the programmer 1-2 weeks after the patient was seen. It was stated, the patient had fallen and tore their rotator cuff. It was noted, the patient fell 1-2 weeks after reprogramming of the dbs. It was stated, the patient was ¿all over the place¿ with movements on their right side and problems with speech, balance, and hallucinations. It was stated, the patient as seen by their family physician on 2014 (b)(6) who had questioned whether it was untoward affect from dbs and or the medication. It was stated, the patient¿s left side settings were decreased. It was noted, the patient¿s medication was also discontinued. It was stated no x-rays were performed. It was noted, the patient as to be seen on the day of report for reprogramming but it was cancelled due to poor weather. It was stated, the wife had rescheduled the appointment for 2014 (b)(6). It was noted the symptoms of jerky movement and affected speech had resolved. It was stated symptoms associated with the event were hyper-movement of left side, speech decreased, and hallucinations. It was stated, the patient sustained torn rotator cuff after fall. It was noted, the patient outcome was non-serious injury or illness. It was stated 2014 (b)(6), the patient was doing well. It was stated, the patient was able to feed themselves. It was stated the patient dressed with minimal assistance and they could put their jeans on. It was noted their speech improved and they were mentally clear. It was stated the patient had a walker that they would use inconsistently.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3595012
« Last Edit: February 07, 2015, 11:44:57 AM by dennis100 » Logged
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« Reply #39 on: February 07, 2014, 07:22:03 AM »

Model Number 37601
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v754185, implanted: (b)(6) 2011,product type: lead. Product id: 3387s-40, lot# v754185, implanted: (b)(6) 2011, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported that the healthcare professional wanted to scan the patient¿s brain to check on possible stroke.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3554525
« Last Edit: February 07, 2015, 11:45:28 AM by dennis100 » Logged
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« Reply #40 on: February 07, 2014, 07:30:12 AM »

Model Number 37601
Event Date 12/14/2013
Event Type  Death  
Patient Outcome  Other,Death,Hospitalization
Manufacturer Narrative
Product id 3387s-40, lot# v875336, implanted: 2012 (b)(6); product type lead product id 3387s-40, lot# v825941, implanted: 2012 (b)(6); product type lead product id 37085-60, lot# serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 37085-60, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient. (b)(4).

Event Description
It was reported that the patient was in the hospital with a ¿massive¿ brain bleed which happened on the saturday prior to the report. A ct scan was done which revealed the bleeding. It was reportedly ¿expected¿ that the patient would die ¿any time now¿. The reporter indicated that ¿no one had said if it was related to the device¿. They reportedly ¿did not know but seemed to be pretty surprised at the amount of blood in the patient¿s brain¿. The reporter was wondering if the device should be turned off. It was later reported that the system was tested the following day and upon interrogation the implantable neurostimulator (ins) was found to be off and all impedances were within normal limits. The patient reportedly experienced loss of consciousness as well as a stroke. The location of the patient¿s symptoms was unknown. The physician determined that the hemorrhage was not a result of the device. The reporter indicated that the patient remained unresponsive, was hospitalized and was subsequently in hospice. Two days after the previous report, it was indicated that the patient died the day prior to the report due to the brain bleed. The death wasn¿t believed to have been device related. If additional information becomes available, a follow-up report will be made available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3566595
« Last Edit: February 07, 2015, 11:46:08 AM by dennis100 » Logged
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« Reply #41 on: February 07, 2014, 08:07:50 AM »

Model Number NEU_INS_STIMULATOR
Event Date 08/14/2013
Event Type  Injury  
Patient Outcome  Other,Required Intervention
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant: product type lead, product id 3387, product type lead, product id neu_ins_stimulator, product type implantable neurostimulator, product id neu_ins_stimulator, product type implantable neurostimulator, product id neu_ins_stimulator, product type implantable neurostimulator, product id neu_ins_stimulator, product type implantable neurostimulator, product id neu_ins_stimulator, product type implantable neurostimulator, product id neu_ins_stimulator, product type implantable neurostimulator, product id neu_ins_stimulator, product type implantable neurostimulator, product id neu_ins_stimulator, product type implantable neurostimulator, product id neu_ins_stimulator, product type implantable neurostimulator, product id neu_ins_stimulator, product type implantable neurostimulator, product id neu_ins_stimulator, product type implantable neurostimulator, product id 3387, product type lead. (b)(4).

Event Description
Peng-chen, z. , morishita, t. , vaillancourt, d. , favilla, c. , foote, k. D. , okun, m. S. , shukla, a w. Unilateral thalamic deep brain stimulation in essential tremor demonstrates long-term ipsilateral effects. Parkinsonism <(>&<)> related disorders. 2013;19(12):1113-1117. Doi: 10. 1016/j. Parkreldis. 2013. 08. 001. Summary: deep brain stimulation (dbs) of thalamus in essential tremor (et) is effective for the treatment of contralateral tremors. Bilateral dbs controls tremors on both sides but is associated with increased morbidityand risks. We evaluated if unilateral surgery had ipsilateral benefits on tremors and thus could be a potentially safer alternative to bilateral dbs. Medication refractory et patients undergoing unilateral thalamic dbs were included and longitudinally followed. Tremor rating scale was used to record total motor, arm tremor and activities of daily living (adl) scores at baseline, six months and at last visit (three or more years after surgery). Postoperative scores were recorded with dbs turned off and on. Twenty-two patients with a mean follow-up 3. 4 _ 0. 14 years were enrolled. When baseline scores were compared to scores with the dbs turned on, significant improvements were noted in total tremor (40%), adl (67%) and arm tremor scores both on the ipsilateral and the contralateral side at six months and at the last visit of follow-up (all p <(><<)> 0. 05). Ipsilateral arm tremor (w56%) improvements were milder compared to the contralateral side (w73%) tremors. Unilateral thalamic dbs in et demonstrates significant long-term benefits for ipsilateral arm tremors and can be offered to higher risk and to select patients. Reported events: 1. 1 patient had air embolus that was transient. 2. 2 patients had superficial infections that were transient. 3. 1 patient had transient hemiparesis due to transient ischemic attack. 4. 1 patient had ¿transient¿ lead fracture. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3586773
« Last Edit: February 07, 2015, 11:47:05 AM by dennis100 » Logged
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« Reply #42 on: April 10, 2014, 05:52:33 AM »

Model Number 37601
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
Concomitant medical products: product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 3389s-40, lot# v443426 , implanted: (b)(6) 2010, product type: lead. Product id: 3389s-40, lot# v415286, implanted: (b)(6) 2010, product type: lead. (b)(4).

Event Description
It was reported that the patient had deep brain stimulator for parkinson¿s disease since 2010 with much success. Previously the patient had only been activated on the right hemisphere for their left side. Recently the patient was activated on the left hemisphere for their right side and it appeared that the patient probably had a minor transient ischemic attack (tia) at that time. Patient was inquiring about mri of their brain to see what happened. Additional information was requested but had not been received as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3709897
« Last Edit: February 07, 2015, 11:47:47 AM by dennis100 » Logged
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« Reply #43 on: April 10, 2014, 09:45:38 PM »

Model Number NEU_INS_STIMULATOR
Event Type  Injury  
Patient Outcome  Hospitalization,Other
Event Description
It was reported there was a post-operation patient bleed that required hospitalization. It was noted the post-operative computed tomography (ct) scan was normal but the bleed occurred the morning after surgery. It was stated there were no issues during the case. It was stated the patient was still in the hospital at the time of report and they were alive with injury. It was noted the patient had a stroke at the lead location.

Manufacturer Narrative
Concomitant medical products: product id 3389s-40, lot# va0e7xh, implanted: 2014-(b)(6), product type lead, product id 3389s-40, lot# va07hd5v02, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3702378
« Last Edit: February 07, 2015, 11:48:29 AM by dennis100 » Logged
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« Reply #44 on: May 11, 2014, 08:03:33 PM »

Model Number 37601
Event Date 11/13/2013
Event Type Injury
Patient Outcome Other
Manufacturer Narrative
Other: stroke. Concomitant medical products: product id 37601, serial# unknown, implanted: 2013-(b)(6), product type implantable neurostimulator, product id 37642, serial# (b)(4), product type programmer, patient. (b)(4).

Event Description
It was reported the patient had a stroke on the operating table when the device on their second side was implanted on 2013-(b)(6). No further information was provided at the time of initial report. Additional information has been requested. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3734289
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« Reply #45 on: May 12, 2014, 02:14:08 AM »

Model Number 37612
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that a month after the patient had been implanted with a bilateral implantable neurostimulator (ins) system ¿they started to see the skin open on the hole drill area. ¿ it was further reported this first occurred with the right side and then the left side. It was ¿the intervention of a plastic surgeon was needed to clean and close the wound. ¿ it was then reported that approximately three months later they started to see the skin on the neck in the extension and lead area start to open. It was stated that this again required the intervention of a plastic surgeon, this time to ¿reconstruct the area. ¿ it was noted a sample of the area was taken and cultured and tested negative for an infection. It was reported the patient¿s physician ¿observed that the skin didn¿t heal until the equipment was turned off¿ and that about a month prior to report ¿he started to notice a skin wound in the pocket area. ¿ it was further reported that a ¿skin lesion on the pocket side¿ had started to appear at that time. It was stated the physician checked the patient the week prior to report and noted that though there was ¿no more infection¿ and that the skin continued to not close, so the physician ¿decided to explant the whole system. ¿ it was reported that when the patient¿s ins was on the patient had experienced a ¿slight improvement in the parkinsonian symptoms. ¿ it was noted the patient¿s parkinson¿s symptoms were being controlled with medicine at the time of report because their ins was off at that time. Regarding the patient's relevant medical history, it was stated that "during the surgery the patient suffered a cerebral infarct with motor secuels. " it was unclear however which surgery was being referred to by the reporter at the time of initial report. Additional information reported the patient¿s system was explanted as scheduled on (b)(6) 2014. It was stated that before surgery the operating physician ¿started to see a wound in the pocket area. ¿ it was noted that upon explant, ¿the physician didn¿t see any physical damage in the system or a bad connection. ¿ it was stated the patient¿s family had refused to return the system for analysis. Additional information noted the patient¿s physician ¿hadn¿t the certainty that the patient problem was related with the equipment. ¿ additional information has been requested. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3758615
« Last Edit: February 07, 2015, 11:49:43 AM by dennis100 » Logged
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« Reply #46 on: June 07, 2014, 11:11:00 AM »

Model Number 37603
Event Date 04/30/2014
Event Type Injury
Patient Outcome Hospitalization,Other
Event Description
It was reported the patient had gone to the office the day prior to report for a reprogramming session. It was stated no programming had been done yet but the patient had a seizure or stroke in the office. It was stated they did not know if it was related to the device and it was unknown if the patient had a history of stroke or seizure. It was noted the patient was admitted to the hospital and the patient status was unknown. It was further reported the cause of the issue was not determined. It was noted the patient was currently hospitalized.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3824909
« Last Edit: February 07, 2015, 11:50:13 AM by dennis100 » Logged
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« Reply #47 on: August 10, 2014, 06:28:41 AM »

Model Number 37601
Event Type Injury Patient Outcome Other
Event Description
It was reported that the patient¿s deep brain stimulator was for shakes and tremors. The patient had not received any training. It was noted that the patient¿s spouse was trying to read the book on how to operate the patient programmer but there was too much information. Inquired if there was someone to come train them in person. The implantable neurostimulator (ins) was implanted on (b)(6) 2014. The ins was not hooked up and the day after the patient had a stroke and 3 days after had a heart attack. Additional information received reported the manufacturing representative was unaware of the stroke or heart attack. The manufacturing representative had met with the patient and spouse via the phone to teach them how to use the patient programmer. Additional information received reported the patient was last seen on (b)(6) 2014 for programming that was a normal and planned appointment. There was no mention of a heart attack or stroke by the patient nor was it in the healthcare professional¿s records. The patient had been in on (b)(6) for cardiac issues. The patient had a re-existing condition of atrial fibrillation. There was no mention of stroke in the file. There was no rule of heart attack in the file, electrocardiogram showed atrial fibrillation with no st elevation. The patient had a long history of seeing a cardiologist for the atrial fibrillation issue and it was not considered to be related to the patient¿s deep brain stimulator system. Additional information was requested but had not been received as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3923574
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dennis100
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« Reply #48 on: October 12, 2014, 02:47:24 AM »

Model Number 7426
Event Date 04/02/2007
Event Type Death
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_ext, serial# (b)(4), product type: extension. Product id: neu_unknown_lead, serial# (b)(4), product type: lead. (b)(4).

Event Description
It was reported that the patient did not have any strokes prior to implant and they started almost immediately after implant. The patient died of a stroke and the reporter stated it was device related. The information provided about the patient¿s death was not from a healthcare professional, so additional information was requested. If additional information is received, a supplemental report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4119196
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« Reply #49 on: October 12, 2014, 12:51:26 PM »

Model Number 37603
Event Date 08/21/2014
Event Type Injury
Event Description
It was reported that the patient had a stroke last (b)(6) 2014. The patient had brain damage and was in a coma in the intensive care unit. The patient¿s daughter inquired about how to turn stimulators off and had inquired if the stimulation was turned on if it would help the patient¿s condition, mental status. It was noted that there would be no repercussions to turning the device off. The patient¿s implanting healthcare professional had not known of any malfunction and they had not heard that there was anything out of the ordinary with the patient¿s case and they also had not heard from them. No interventions or outcome were reported regarding this event. Additional information could not be obtained at the time of the report. Should additional information be received a supplemental report will be filled. Reference manufacturer's report number: 3004209178-2014-17043.

Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3387s-40, lot# va0aue6, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4090294
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« Reply #50 on: October 13, 2014, 12:52:09 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v354660, implanted: (b)(6) 2009, product type: lead. Product id: 7438, serial# (b)(4), product type: programmer, patient. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

Event Description
It was reported that the patient had a stroke after implanted four years prior to the report. Information regarding the cause of the event, reprogramming that was completed, and patient outcome have been requested, which was not reported regarding this event. If additional information is received, a follow-up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4078249
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« Reply #51 on: November 08, 2014, 12:42:20 AM »

Model Number 37612
Event Date 10/07/2014
Event Type Injury
Event Description
It was reported the patient had been admitted to the hospital for a possible stroke. The ct scan had been done and it showed a distal end of lead tip to the brain and proximal end of the lead ends at the ear location. They could see added bulk at the proximal end of the lead by the ear. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 37085-60, serial# (b)(4), implanted: (b)(4) 2012, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 3387s-40, lot# v964030, implanted: (b)(6) 2012, product type: lead. Product id: 3387s-40, lot# v964030, implanted: (b)(6)2012, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4207170
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« Reply #52 on: January 10, 2015, 05:22:35 AM »

Model Number 37602
Event Date 11/15/2014
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3389-40, lot# j0301149v, implanted: (b)(6) 2003, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2002, product type: extension. Product id: 3389-40, lot# j0230871v, implanted: (b)(6) 2002, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2002, product type: extension. Product id: neu_ptm_prog, serial# unknown, product type: programmer, patient. (b)(4).

Event Description
It was reported the deep brain stimulator (dbs) was working well but the patient had a minor stroke 3 days prior to report and had to go to the hospital but the patient was ¿fine now. ¿ they were able to turn the stimulator off so they could do a test and then turn it back on ¿which was a big help. ¿ they ¿seemed to not think¿ the stroke was related to the dbs implants.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4318111
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« Reply #53 on: February 07, 2015, 07:21:11 AM »

Model Number 3387S-40
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported the patient had a stroke at the time of the lead implant and therefore the system was never completely implanted. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4443337
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« Reply #54 on: February 07, 2015, 07:21:43 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 3389-40, lot# j0546584v, implanted: 2005 (b)(6); product type lead product id 748240, serial# (b)(4), implanted: 2005 (b)(6); product type extension product id 3389-40, lot# j0546241v, implanted: 2005 (b)(6); product type lead product id 748240, serial# (b)(4), implanted: 2005 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient. (b)(4).

Event Description
It was reported that the patient was in the hospital at the time of this report because, they thought he may have had a stroke on monday morning prior to the date of this report. No intervention or outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4421273
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« Reply #55 on: February 07, 2015, 11:50:51 AM »

Model Number NEU_UNKNOWN_LEAD
Event Type Injury
Event Description
It was reported the patient presented in the emergency room with stroke symptoms. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4392749
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dennis100
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« Reply #56 on: March 07, 2015, 04:56:10 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0njz7, implanted: (b)(6) 2014, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

Event Description
It was reported that the patient was implanted unilaterally left ventral intermediate nucleus on (b)(6) 2014 and had suffered an ischemic stroke in (b)(6) 2014 in the left hemisphere. The healthcare professional had not believed that it was deep brain stimulator related. The neurologist had turned the patient¿s implantable neurostimulator (ins) off on the day prior to the date of this report in the clinic as they had not wanted the dbs to mask any residual stroke symptoms until post rehab. They were inquiring about programming post stroke. No outcome was provided and it was unclear if the stroke was confirmed to be unrelated. Further follow-up is being conducted to obtain this information. If additional information is received, a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4530544
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dennis100
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« Reply #57 on: March 07, 2015, 04:57:02 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that the patient had a stroke on (b)(6) prior to the date of this report. It was noted that surgery was not required. The programmer had been lost during room to room transfer. The healthcare professional was not sure if the stroke was related to the device therapy or not. The patient was in outpatient rehab and the patient was still high functioning and had a great memory. Reprogramming was mentioned. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant product: product id 3387-40, lot # j0313854v, implanted: (b)(6) 2003, product type lead; product id neu_ unknown_ext, serial # (b)(4), implanted: (b)(6) 2003, product type extension; product id 37642 , serial # (b)(4), product type programmer, patient. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4519160
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dennis100
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« Reply #58 on: March 07, 2015, 04:57:37 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant products: product id neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2006, product type lead; product id 37642, serial# (b)(4), product type programmer, patient; product id 748240, serial# (b)(4), implanted: (b)(6) 2006, product type extension. (b)(4).

Event Description
It was reported that the patient was in the hospital ¿a couple week ago. ¿ the reporter thought this was due to a mini stroke. The patient would be going to physical and speech therapy. No interventions or patient outcome were reported, so additional information was requested. If additional information is received a supplemental report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4484910
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« Reply #59 on: April 19, 2015, 02:53:42 AM »

Model Number 3389S-40
Event Date 03/02/2015
Event Type Injury
Event Description
It was reported the patient had a suspected stroke. A post-operative ct scan showed bleeding at the tip of the patient¿s right lead. Hospitalization was required. The patient¿s healthcare professional (hcp) stated the patient was recovering, they were doing well, and they were not suffering from any deficit. The hcp anticipated the patient would undergo the stage two implant in the next week or two.

Manufacturer Narrative
Concomitant products: product id neu_ins_stimulator, serial # unknown, product type implantable neurostimulator; product id neu_unknown_ext, serial # unknown, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4632177
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