Pages: 1 2 3 [All]   Go Down
Print
Author Topic: Deep brain stimulator - Stroke  (Read 28506 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« on: November 09, 2013, 02:18:50 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative

 
Event Description

Journal reference: papavassiliou e, rau g, heath s, et al. Thalamic deep brain stimulation for essential tremor; relation of lead location to outcome. Neurosurgery. 2008; 62(suppl. 2): 1120-1130. Thalamic deep brain stimulation (dbs) is commonly used to treat essential tremor, but the optimal lead location within the thalamus has not been systematically evaluated. We examined the relation of lead location to clinical outcome in a series of essential tremor patients treated by thalamic dbs. Fifty-seven leads in patients were studied. Reportable event: in one patient the lead was not evaluated, due to the patient having a stroke 4 months after implantation. See mfg report #218220720087354.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1229682

« Last Edit: February 03, 2014, 02:45:42 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #1 on: November 09, 2013, 12:27:49 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Type  Injury   Patient Outcome  Disability,Hospitalization
Event Description

During implant, the surgeon woke the pt up and told her to touch her nose with her right hand. The pt was unable to talk and tell the surgeon that she couldn't reach her nose; she couldn't move it. It was determined that the pt had a stroke on the operating table. The pt spent 4 days in the hospital following the stroke. The pt completed speech and physical therapy. The pt long term effects were that now she needed to write things down because she forgot and "cognitive things are hard". The pt was also depressed. The pt thought the surgery was going to change her life for the better, but it "ruined it".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1543921
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #2 on: December 06, 2013, 12:16:40 PM »

Model Number 7428
Event Date 11/07/2013
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that the patient was implanted on (b)(6) 2013 with a deep brain stimulator. It was noted that during the hospitalization the patient had a cerebral infarction. The patient received an emergency treatment from the doctor and the patient¿s life was no longer in danger. The patient was then sent to a local hospital for treatment and recuperation. The doctor¿s opinion was that the patient had serious diabetes and a narrow neck vessel. The patient¿s brain was under long term hyperglycemia and ischemia situation. The blood vessels were very fragile. The cerebral infarction had happened after the operation. Both the doctor and the patient thought there was no problem with the product.

 
Manufacturer Narrative
Concomitant products: product id 7482-51, serial # (b)(4), product type extension; product id 7482-51, serial # (b)(4), product type extension; product id 3389s-40, lot # va097pq, product type lead; product id 3389s-40; lot # va0aaas; product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3487870
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #3 on: December 06, 2013, 12:17:32 PM »

Model Number 7426
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Concomitant medical products: product id 37601, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 64001, lot# n301003, implanted: (b)(6) 2012, product type: adapter; product id 3387s-40, lot# v591417, implanted: (b)(6) 2012, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3389-40, lot# j0220169v, implanted: (b)(6) 2002, product type: lead; product id 7495-51, serial# (b)(4), implanted: (b)(6) 1999, product type: extension. (b)(4).

 
Event Description
The patient had a stroke and needs an mri. It was thought that the stroke was unrelated to the device. It was unknown when the stroke occurred. The company representative confirmed on (b)(6) 2013 that the left hemisphere has one gpi and one lead connected to the ins which was not activated with stimulation. The impedance measurements were greater than 40,000 ohms with all combinations, which disqualified him for an mri. The other side impedance measurements were greater than 2,000 ohms on all combinations except 0 and c which were within range. This side was only tested at 1. 5v and not tested to 3. 0v. No cause was determined. The patient had regular stroke management and the device was not touched. It was noted that no comments were made about the device not being effective and nothing has or will be explanted. Reference manufacturer report# 3004209178-2013-20751.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3467749
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #4 on: December 06, 2013, 12:18:11 PM »

Model Number 7426
Event Date 11/04/2008
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported that a patient was told that ¿the electrode may be in the wrong place¿ since she had surgery in 2008 or 2009. It was stated that one doctor thought she had a stroke. It was noted that the area being stimulated ¿might be the wrong area,¿ thus the patient was going to have an mri to determine if that was the case. The patient reportedly never had a tremor before the surgery and ¿since she got the device put in her whole right side was affected but it was inconsistent. ¿ a supplemental report will be sent if any additional information is received.

 
Manufacturer Narrative
Concomitant products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2008, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 3387s-40, lot# v236672, implanted: (b)(4) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3462533
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #5 on: December 07, 2013, 06:06:11 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Event Description
The patient had a stroke and needs an mri. It was thought that the stroke was unrelated to the device. It was unknown when the stroke occurred. The company representative confirmed on (b)(4) 2013 that the left hemisphere has one gpi and one lead connected to the ins which was not activated with stimulation. The impedance measurements were greater than 40,000 ohms with all combinations, which disqualified him for an mri. The other side impedance measurements were greater than 2,000 ohms on all combinations except 0 and c which were within range. This side was only tested at 1. 5v and not tested to 3. 0v. No cause was determined. The patient had regular stroke management and the device was not touched. It was noted that no comments were made about the device not being effective and nothing has or will be explanted.

 
Manufacturer Narrative
Product id 7426, serial# (b)(4), implanted: 2008 (b)(6); product type implantable neurostimulator product id 64001 lot# n301003, implanted: 2012 (b)(6); product type adapter product id 3387s-40 lot# v591417, implanted: 2012 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 37085-60, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 3389-40, lot# j0220169v, implanted: 2002 (b)(6); product type lead product id 7495-51, serial# (b)(4), implanted: 1999 (b)(6); product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3455595

Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #6 on: December 07, 2013, 06:06:48 AM »

Model Number 37603
Event Date 08/24/2013
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that there was inflammation around the tip of the lead. It was reported that the patient presented to the er on 2013 (b)(6) with stroke like symptoms, right facial droop, difficulty speaking and weakness in the right leg. It was noted that explant was a required action. It was noted that multiple ct scans were performed between 2013 (b)(6) and 2013 (b)(6) and an mri was also performed. It was noted that the patient was doing well after the lead and battery were placed at the original implant. It was noted that upon examination of the ct it was noted that the patient had a well-defined area of hypo-density surrounding the end of the lead. It was noted that the health care professional (hcp) did not believe it was an infection. It was noted that the patient had come back several times with the same complaints and it was ultimately decided to take the system out. It was noted that the patient was implanted in the left ventral intermediate nucleus. It was noted that the patient was given plavix, antibiotics and steroids during the process of at least two other hospitalizations. It was noted that the hcps did not believe it was an infection and were examining t heir procedures.

 
Manufacturer Narrative
Product id 3708660, serial# (b)(4), implanted: 2013 (b)(6), explanted: 2013 (b)(6); product type extension product id 3389s-40 lot# va09s07, implanted: 2013 (b)(6), explanted: 2013 (b)(6); product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3479243
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #7 on: December 07, 2013, 06:07:39 AM »

Model Number 3389S-40
Event Date 10/31/2013
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that there was unexplained edema surrounding the lead. It was noted that an explant of the lead was planned for (b)(6) 2013. It was noted that the patient had one complete left deep brain stimulation system implanted last year. It was noted that the patient was then implanted with a lead on the right side. It was noted that approximately 1 to 2 weeks later the patient was presented to the er with seizures. It was noted that a ct of the lead noted a non-infectious swelling surrounding the end of the lead. It was noted that the surgeon was convinced that it was not an abscess or infection. It was noted that they were not certain if the issue was the product, procedure or patient related. It was noted that the lead was being removed. It was noted that the patient was hospitalized and the reporter was unsure of what medical intervention was done. It was noted that multiple ct scans were performed. Additional information received reported that the patient did not have seizures but had more symptoms that resembled a stroke.

 
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3479050
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #8 on: December 09, 2013, 05:11:53 AM »

Model Number NEU_INS_STIMULATOR
Event Date 05/10/2013
Event Type  Death   Patient Outcome  Death
Event Description
Weintraub, d. , duda, j. E. , carlson, k. , luo, p. , sagher, o. , stern, m. , follett, k. A. , reda, d. , weaver, f. A. Suicide ideation and behaviours after stn and gpi dbs surgery for parkinson's disease: results from a randomised, controlled trial. Journal of neurology, neurosurgery, and psychiatry. 2013;84(10):1113-1118. Summary: the risk of suicide behaviours post¿deep brain stimulation (dbs) surgery in parkinson¿s disease (pd) remains controversial. We assessed if suicide ideation and behaviours are more common in pd patients (1) randomised to dbs surgery versus best medical therapy (bmt); and (2) randomised to subthalamic nucleus (stn) versus globus pallidus interna (gpi) dbs surgery. In phase 1 of the (b)(4) study, 255 pd patients were randomised to dbs surgery (n=121) or 6 months of bmt (n=134). For phase 2, a total of 299 patients were randomised to stn (n=147) or gpi (n=152) dbs surgery. Patients were assessed serially with the unified parkinson¿s disease rating scale part i depression item, which queries for suicide ideation; additionally, both suicide behaviour adverse event data and proxy symptoms of increased suicide risk from the parkinson¿s disease questionnaire (pdq-39) and the short form health survey (sf-36) were collected. In phase 1, no suicide behaviours were reported, and new-onset suicide ideation was rare (1. 9% for dbs vs 0. 9% for bmt; fisher¿s exact p=0. 61). Proxy symptoms of relevance to suicide ideation were similar in the two groups. Rates of suicide ideation at 6 months were similar for patients randomised to stn versus gpi dbs (1. 5% vs 0. 7%; fisher¿s exact p=0. 61), but several proxy symptoms were worse in the stn group. Results from the randomised, controlled phase of a dbs surgery in pd patients do not support a direct association between dbs surgery and an increased risk for suicide ideation and behaviours. Reported event: one male patient with globus pallidus interna (gpi) deep brain stimulation (dbs) committed suicide 10 months post-surgery. This patient was originally randomized to the best medical therapy (bmt) group, but 3 months later was re-randomized into the gpi dbs group. On the first night following dbs surgery, the patient had experienced a left hemisphere cerebrovascular accident secondary to an intracranial hemorrhage lateral to the left dbs lead, with expressive aphasia and right-sided weakness. The patient was hospitalized for six weeks and experienced some memory problems, word finding difficulties, depressive symptoms and emotional lability. The patient was then started on an antidepressant. Approximately one month later, the patient¿s cognitive and psychiatric symptoms had improved. At the patient¿s six month study assessment, the patient¿s motor score in the on-medication/on-stimulation state had worsened from the baseline by five points. At the six month assessment, the patient also expressed worsening depressive symptoms and suicide ideation; the patient was then hospitalized psychiatrically for approximately one month and had an adjustment to antidepressant medication in addition to receiving psychosocial treatment. It was noted that the patient had felt much improved on discharge. The patient committed suicide four months later. The suicide was attributed to situational depression and overall physical decline, given the postoperative time course, self-reported financial hardships, and extensive medical complications postoperatively and stability of the dbs settings prior to the suicide. Further information has been requested; a supplemental report will be submitted if additional information is received.

 
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 products: product id neu_unknown_lead, lot # unknown, product type lead; product id neu_unknown_lead, lot # unknown, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3397552
« Last Edit: February 03, 2014, 02:46:01 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #9 on: December 09, 2013, 05:13:19 AM »

Model Number NEU_INS_STIMULATOR
Event Date 02/28/2011
Event Type  Death   Patient Outcome  Death
Event Description
Hwynn, n. , hass, c. J. , zeilman, p. Romrell, j. Dai, y. , wu,s. Foote,k. , subramony, s. H. , oyama, g. ,velez-lago,f. , fernandez,h. , resnick,a. , malaty,i. , okun,m. Steady or not following thalamic deep brain stimulation for essential tremor. J neurol. 2011;258(9):1643-1648. Doi 10. 1007/s00415-011-5986-0 summary: deep brain stimulation (dbs) has become an important option for medication-refractory essential tremor (et), but may contribute to worsened gait and falling. This study evaluates impaired gait in a cohort of patients treated with dbs with a retrospective review of et patients before and after dbs implantation. Factors examined included: age, duration of symptoms, pre-morbid gait difficulties/falls, fahn-tolosa-marin tremorrating scale (trs) scores at baseline, 6 months post-unilateral dbs implantation, and 6 or 12 months post-bilateral implantation. All implantations targeted the nucleus ventralis intermediate (vim). Thirty-eight patients (25 males, 13 females) were included. Twenty-five patients (65. 8%) underwent unilateral dbs implantation and 13 (34. 2%) bilateral. The mean age at surgery was 67. 1 years ± 11. 4 (range 34¿81). The mean disease duration was 31 years ± 18. 3 (range 6¿67). Fifty-eight percent of patients had worsened gait postoperatively. Seventy percent of patients with unilateral vim dbs experienced gait worsening while 55% of bilateral dbs patients experienced gait worsening. Patients with worsened gait post-dbs had higher baseline preoperative trs scores than those without worsened gait (43. 1 points ± 8. 4 vs. 33. 1 points ± 10. 1, p = 0. 002) (odds ratio 2. 5, p = 0. 02). Gait/balance may worsen following dbs for medication refractory et. Higher baseline trs score mayfactor into these issues, although a l arger prospective study will be required with a control population. The larger percentage of difficulties observed in unilateral versus bilateral cases likely reflected the bias to not proceed to second-sided surgery if gait/balance problems were encountered. Reported events: 1. 1 patient had postoperative dbs-unrelated death before clinic follow-up 2. 2 patients had postoperative infection resulting in leads surgically removed within 6 months post-dbs 3. 1 patient had ischemic stroke. Further information has been requested; a supplemental report will be submitted if additional information is received.

 
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. 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. Product id: 3387, lot# unknown, product type: lead. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: 3387, lot# unknown, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3229671
« Last Edit: February 03, 2014, 02:46:12 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #10 on: December 09, 2013, 05:14:19 AM »

Model Number 7426
Event Date 03/01/2013
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that the patient died on (b)(6) 2013. It was noted that the cause of death was that the patient had contracted blood clots along with his parkinson's and it caused a stroke. It was also noted that the death was not related to the device or therapy.

 
Manufacturer Narrative
Product id 7426, serial # (b)(4), implanted: (b)(6) 2006, product type implantable neurostimulator; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 3389s-40, lot # v010290, implanted: (b)(6) 2006, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 3389s-40, lot # v010290, implanted: (b)(6) 2006, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3100653
« Last Edit: February 03, 2014, 02:46:23 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #11 on: December 10, 2013, 07:22:03 AM »

Model Number 7428
Event Date 04/15/2013
Event Type  Death   Patient Outcome  Death
Event Description
Torres, c. V. , sola, r. G. , pastor, j. , pedrosa, m. , navas, m. , garcía-navarrete, e. , ezquiaga, e. , garcía-camba, e. Long-term results of posteromedial hypothalamic deep brain stimulation for patients with resistant aggressiveness. Journal of neurosurgery. 2013;119(2):277-287. Doi: 10. 3171/2013. 4. Jns121639 summary: erethism describes severe cases of unprovoked aggressive behavior, usually associated with some degree of mental impairment and gross brain damage. The etiology can be epileptic, postencephalitic, or posttraumatic, or the condition can be caused by brain malformations or perinatal insults. Erethism is often refractory to medication, and patients must often be interned in institutions, where they are managed with major restraining measures. The hypothalamus is a crucial group of nuclei that coordinate behavioral and autonomic responses and play a central role in the control of aggressive behavior. Deep brain stimulation (dbs) of the posteromedial hypothalamus (pmh) has been proposed as a treatment for resistant erethism, although experience with this treatment around the world is scarce. The objective of this study was to examine the long-term outcome of pmh dbs in 6 patients with severe erethism treated at the authors¿ institution. Medical records of 6 patients treated with pmh dbs for intractable aggressiveness were reviewed. The therapeutic effect on behavior was assessed by the inventory for client and agency planning preoperatively and at the last follow-up visit. Two patients died during the follow-up period due to causes unrelated to the neurosurgical treatment. Five of 6 patients experienced a significant reduction in aggressiveness (the mean inventory for client and agency planning general aggressiveness score was -47 at baseline and -25 at the last follow-up; mean follow-up 3. 5 years). Similar responses were obtained with low- and high-frequency stimulation. In 4 cases, the patients¿ sleep patterns became more regular, and in 1 case, binge eating and polydipsia ceased. One of the 3 patients who had epilepsy noticed a 30% reduction in seizure frequency. Another patient experienced a marked sympathetic response with high frequency stimulation during the first stimulation trial, but this subsided when stimulation was set at low frequency. A worsening of a previous headache was noted by 1 patient. There were no other side effects. In this case series, 5 of 6 patients with pathological aggressiveness had a reduction of their outbursts of violence after pmh dbs, without significant adverse effects. Prospective controlled studies with a larger number of patients are needed to confirm these results. Reported event: a female patient died 6 months after surgery as a consequence of a stroke. Further information has been requested; a supplemental report will be submitted if additional information is received.

 
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. 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. Product id: 3389, lot# unknown, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3335291
« Last Edit: February 03, 2014, 02:46:33 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #12 on: December 10, 2013, 07:22:32 AM »

Model Number 37601
Device Problem No Known Device Problem
Event Date 06/21/2011
Event Type  Death   Patient Outcome  Death
Event Description
On (b)(6) 2011, the pt suffered a stroke and subsequently passed away. The physician revealed that there was evidence on the mri of previous stroke and thus presumably the pt was at higher risk of stroke. The physician believes the procedure rather than the ins components caused the stroke.

 
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2167192
« Last Edit: February 03, 2014, 02:46:43 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #13 on: December 23, 2013, 02:34:56 AM »

Model Number 3389
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2007
Event Type  Death   Patient Outcome  Death
Event Description
The manufacturer representative reported placement of bilateral dbs system. Pt status post implant was initially fine with no complications noted. The patient presented to a hosp for treatment three to five days post implant and suffered a fatal stroke. The exact date the pt expired is unk. No report of lead explant has been received by the manufacturer. The representative provided the two leads implanted were from the same manufacturing lot number. The device has not been received by the manufacturer for analysis. No other information is available. Additional info has been requested from the physician. 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=812851
« Last Edit: February 03, 2014, 02:46:55 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #14 on: December 23, 2013, 02:36:28 AM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Death   Patient Outcome  Death
Event Description
The hcp report in 2006 the pt experienced a stroke the evening after surgery and is now experiencing worsening depression and suicidal thoughts. In 2006, the hcp reported the pt was attending out pt mental health sessions once per week and the severe depression had resolved. Additional info rec'd via dbs clinical adverse event reports dated for 5 days indicate the pt committed suicide secondary to depression. The most recent updated sae report indicates: the pt was a man with idiopathic parkinson's disease since 1983 that lived in an assisted living facility. He enrolled in the study in 2005 and had the dbs system implanted in 2005. The surgery proceeded well and without complication. However, the evening after his surgery, the pt developed acute mental status changes and right hemi paresis, with ct scan showing a hemorrhagic stroke centered in the left putamen and extending into the insular cortex. The pt ultimately largely recovered from the stroke, but had mild residual effects of dysarthria and mild cognitive impairment. His parkinsonian motor symptoms were substantially improved with dbs treatment. In 2006 the pt was seen for his six month follow up visit. During the visit, the pt expressed depression and suicidal thoughts. Psychiatry service was consulted and they recommended that the pt be admitted. The pt was hospitalized for 21 days. Treatment included antidepressant medication, as well as individual and group psychotherapy. The pt's deep brain stimulation settings were adjusted on day 3 of hospitalization in case stimulation was contributing to the pt's depression - although this was felt to be unlikely. Following treatment with antidepressant medication and psychotherapy, the pt's depression significantly improved and he was discharged to his assisted living facility. The pt continued to participate in the outpatient psychiatric treatment program for approx 43 days. Upon discharge, the pt's depression was assessed to be greatly improved and was attributed to situational issues, including financial stressors and coping with medical illness; the pt was instructed to follw up with psychiatric services closer to home. The pt was last seen at the outpatient eval and assessment sevice in 2006 and treated with ketoconazole cream and shampoo for a skin rash. Approx 2 months later, the study center was notified from the pt's assisted living facility that the pt was deceased and that he was found by a caregiver at 2:00 am with a bag over his head and a belt around the neck. The suicide appears to be due to situational depression and may also reflect progression of the pt's parkinson's disease. Give the stability of the dbs setting and the temporal course of the suicide, it seems improbable that the suicide is related to study-related procedures or treatment. Current medications at the time of the event were: sinemet 25/100, entacapone 200mg, sinemet 50/200, olanzapine 2. 5mg, trazodone 100mg, citalopgram 20mg, terazosin 2mg, omeprazole 20mg, sodium chloride 1gm, fludrocortisone 0. 1mg, senna 8. 6mg, oxybutynin 5mg, hydrocortisone cream, ducosate 250mg, bisacodyl 5mg, bodan pad, and ketoconazole 2% cream.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=794838
« Last Edit: February 03, 2014, 02:47:05 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #15 on: January 03, 2014, 07:10:26 PM »

Device Problem Device remains implanted
Event Date 01/24/2007
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Information received via a university hosp clinical study report indicates implantation of the dbs electrodes was uneventful in 2007, other than some pt sleepiness (somnolence) noted during the surgery. Post-operative ct scan did not show any evidence of hemorrhage or other complication. The partial dbs system placed in 2007 was reportedly a medtronic activa system. The physician reports the subject was not improved one day after the procedure and was kept in the hosp for three additional days over the course of which he improved, but had not attained his preoperative level of function as of the date of the report received five days later. A ct scan performed on 01/2007 revealed either swelling detected around the electrode, or an area of small infarct noted in the pt left basal ganglia. The physician investigator indicated the serious adverse event was likely related to the research procedures. No report has ben received by the manufacturer of device explant. Additional information was received twenty three days later from the hcp. The full dbs system has not yet been placed; only the leads were implanted on the date of event. Implantation of the ipg is anticipated next week and the final serial numbers for all products placed will be reported to the manufacturer at that time. A follow-up report will be sent when additional info becomes available. The hcp confirmed the previous report of pt symptom of sleepiness; additional symptoms reported by the hcp on 02/21/2007 included slurring of speech, difficulty finding words and the pt has reportedly been walking into walls. The hcp also reported recent confirmation from the clinic that the pt did suffer a post-operative stroke. The pt has been monitored in the hosp for five days and is currently receiving physical therapy. The pt's condition is improving daily, as reported by the spouse, but has not fully returned to pre-operative baseline. See mfr's report number 2182207-2007-00689.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=823902
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #16 on: January 03, 2014, 07:25:13 PM »

Model Number 7428
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
An er hcp reported the patient has increased tremors and stroke-like symptoms. The deep brain stimulation system was turned on a week ago. No report of device explantation. Additional information has been requested by medtronic from the health care professional regarding the reported event. A supplemental mdr follow-up report will be sent to fda if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=835871
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #17 on: January 05, 2014, 02:31:01 PM »

Model Number 3387
Device Problems Intermittent continuity; Device remains implanted; Implant, reprogramming of; Wire(s), breakage of; Suspect EMI
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
The patient reported in 2007, that his ins had been turning off and on for eight weeks; the patient had reported many falls at follow-up in the following month. The representative verified the battery status via patient programmer and redirected the patient to the hcp. The hcp reported the next month, that the patient had experienced severe balance problems prior to system placement and after dbs implant. The patient had also suffered a several myocardial infarction (date not provided), that required defibrillation five times and resulted in a partial break in the dbs lead wires. The patient then suffered a stroke subsequent to mi and an aicd system was placed. The partial lead break progressed to a complete wire fracture and the dbs system was reprogrammed from monopolar to bipolar settings to avoid interference with the aicd. The patient indicated that his dbs system had recently been turning off and on at his place of employment; the patient works with computers. The patient was deemed too much of a risk to attempt surgical revision because of his condition. Additional information has been requested. See mfr report #6000153-2007-02706.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=902861
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #18 on: January 06, 2014, 09:13:33 PM »


Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: kenney, et al. "short-term and long-term safety of deep brain stimulation in the treatment of movement disorders. " journal of neurosurgery; 2007, 106:621-625. The study describes the results of a retrospective analysis of adverse events in movement disorder pts treated with deep brain stimulation (dbs) at baylor college of medicine between 1995 and 2005 along with a comparison analysis of the medical literature. Reportable event: one pt experienced a transient ischemic attack (tia) during the intraopertive recording/electrode implant stage of the surgery. Treatment and outcome info was not provided.

 
Manufacturer Narrative
Journal reference: kenney, et al. "short-term and long-term safety of deep brain stimulation in the treatment of movement disorders. " journal of neurosurgery; 2007, 106:621-625. Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each pt, the devices used and the complications experienced was not provided. It is possible that each pt may have experienced more than one complication. No medwatc form was received from the user facility. Therefore, info on the medwatch form 3500a was completed by medtronic with info from the article. See scanned pages.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=951335
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #19 on: January 08, 2014, 04:21:45 PM »

Model Number 3389
Device Problem Implant, removal of
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization,Disability
Manufacturer Narrative
See scanned pages.

 
Event Description
Journal reference: gan et al. "bilateral subthalamic nucleus stimulation in advanced parkinson's disease, three year follow-up", journal of neurology (2007) 254:99-106. The study objective is to assess the long-term efficacy and safety of chronic bilateral stimulation of the subthalamic nucleus (stn) in consecutive patients. The article describes results of a study involving patients being treated with bilateral -stn dbs for advanced parkinsons disease. Parkinsonian status was investigated postoperative, at 1 year and 3 year intervals. Both transient and long lasting complications were included in the article. During the dbs lead implant procedure, one patient experienced a left-sided intracerebral bleed resulting in a slight permanent aphasia. The implant was interrupted and had to be placed two months after the stroke.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=930535
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #20 on: January 08, 2014, 04:22:39 PM »

Model Number 3387
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Journal article reported the pt was diagnosed with parkinsons in 1992. The pt was scheduled for surgery in 2005. After a couple of delays, due to a heart attack and back problems, the pt finally underwent surgery around the end of 2005. Shortly after the surgery, the pt suffered a stroke, a possible side effect of the surgery. The pt survived the stroke and now feels the benefits of the therapy. Add'l info has been requested by medtronic from the health care professional regarding the reported event. A supplemental mdr follow-up report will be sent to fda if add'l info is received. Refer to medwatch report # 6000153200702392.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=884268
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #21 on: January 08, 2014, 04:23:46 PM »

Event Type  No Answer Provided 
Event Description
Journal reference: anderson, v. C. , et al. "pallidal vs. Subthalamic nucleus disease stimulation in parkinson disease. " arch. Neurol. 2005; 62: 554-560. The article describes a randomized, blinded pilot comparison of the safety and efficacy of stn and gpi stimulation in 23 pts with advanced idiopathic parkinsons. The pts were implanted bilaterally with dbs lead (model 3382 or 3387) and neurostimulator (model itrel 2 or soletra). Reportable events: lead (n=2) - one female pt experienced unexplained severe pd progression after 6 months of dbs therapy. She was treated with antibiotics for recurrent utis. At 12 months she was severely badykinetic and rigid, unable to communicate and had difficult swallowing. Lead (n=2) - one pt experienced ischemic stroke with persistent neurologic deficit. Lead (n=2) - one pt experienced extracranial lead fracture after falling. Lead (n=2) - one pt experienced memory deficits, difficulty concentrating and apathetic mood within weeks of surgery that persisted throughout therapy. Lead (n=6) - three pts experienced delirium. Lead (n=4) - two pts experienced anxiety. Lead (n=2) - one pt had mild visual field defects. Lead (n=2) - one pt experienced hallucinations.

 
Manufacturer Narrative
This report is being filed under exemption.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=921676
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #22 on: January 09, 2014, 09:08:31 AM »

Device Problem Device remains implanted
Event Date 11/02/2007
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
The pt underwent deep brain stimulation implant; during stage one surgery in 2006, he suffered acute ischemia in the right frontal lobe, which was diagnosed as cva secondary to dbs implant. He had rehabilitation; the pt received physical and occupational therapy and returned to baseline except for slight weakness in his lower extremity, which had been attributed to cva. At follow-up with the hcp via phone on 1/9/2008, the pt's daughter reported that the pt had fallen in 2007, and subsequently experienced left hip pain with an inability to stand or walk. Exam at the emergency room had revealed a fractured left-hip five days prior. The pt was admitted to the hospital two days later for left-hip hemiarthroplasty and experienced prolonged hospitalization secondary to left-sided weakness. Post-operatively the pt was confused; the confusion had been attributed to treatment with morphine, which was discontinued. The pt had been transfused with two units of blood for a reported drop in hemoglobin (pertinent test results were not available). The following day, the pt had been discharged to a rehabilitation center and then to a nursing home.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002342
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #23 on: January 09, 2014, 05:16:20 PM »

Model Number 3387
Device Problems High impedance; Device remains implanted
Event Date 05/13/2008
Event Type  Malfunction 
Event Description
It was reported that the system was interrogated because the patient anticipated an mri exam "due to a possible strike. " findings revealed high impedance readings were obtained on all or some of the unipolar electrode pairs. There were no patient symptoms reported and no other issues were detected from the implanted system. No programming changes were noted. 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=1059971
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #24 on: January 09, 2014, 05:16:51 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported the patient experienced nausea and vomiting after cataract surgery. The patient was admitted to the hospital with "stroke-like symptoms". No other symptoms or outcome were provided. 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=1059854
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #25 on: January 12, 2014, 05:17:46 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: d. Fontaine et al. "subthalamic nucleus stimulation using a fisher zd stereotactic frame mr-ct fusion guidance and preoperative orthogonal radiographs, in parkinson's disease" neurochirurgie 53 (2007) 463-469. The article describes the method and results of a technique to implant electrodes in the stn for treatment of pts with idiopathic parkinson's disease. Sixty (60) pts with motor fluctuations and/or dopa-induced dyskinesia had the stn bilateral implantation surgery. Several complications were reported as noted below. Reportable event: long-term results showed 2 cases of major cognitive worsening, one following a cva that occurred several mos after surgery and the second was without obvious explanation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1015213
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #26 on: January 13, 2014, 10:22:07 AM »

Model Number 3389
Device Problems Electro-magnetic interference (EMI); Implant, reprogramming of
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported, the pt lost therapeutic effect and experienced facial numbness after leaning over some amplification speakers (containing magnets). No changes in programming were found. The pt was seen by a health care professional (hcp) for reprogramming two weeks later. The hcp suspected the pt may have experienced a small stroke which might have caused the symptoms. The hcp will perform additional test. Additional info has been requested, a follow-up report will be submitted when/if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1036465
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #27 on: January 13, 2014, 10:47:08 AM »

Model Number 3387
Device Problems Performance; Device remains implanted
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Disability,Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported that following stage 1, bilateral lead placement in 2007, "they had noted a change in the patient". The physician indicated the patient had suffered a stroke (the exact date of onset was not reported); the event had been attributed to the lead device. The patient had been seen for one post-operative visit with the surgeon (exact date was not given). The patient had hemiplegia; it was unknown which side had been affected. She had received short-term rehabilitation (dates and type of facility were not provided), and had subsequently been discharged to home. The patient's condition was non-ambulatory; she had been able to walk prior to the surgery. The patient reported in 2008, that the system had been reprogrammed in 2008. No symptoms had been provided but the patient stated that after reprogramming "it helped for a short while". There had been painful right leg spasms, that had occurred whenever she sat down. She had tried increasing her parkinson's medications and achieved symptom suppression for a few hours before spasms would return. At follow-up for programming the following month, the hcp stated that the patient had been responding well to treatment but at times does have symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1013780
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #28 on: January 18, 2014, 12:28:01 AM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/29/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported the pt experienced a stroke in 2009. Several days later, the pt was to have a ct scan and experienced a loss of therapeutic effect with "staring into space with hardly a response". The pt was admitted to the hosp. It was unk if the device was on or off. It was requested the manufacturer's rep check the pt's system while in the hosp. No further outcome was reported. Additional info has been requested, a f/u report will be submitted if additional info becomes available. Please see mfr. Report #3004209178200901502.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1333325
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #29 on: January 20, 2014, 01:35:29 PM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 06/20/2009
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Literature: okun ms, fernandez hh, wu ss, et al. Cognition and mood in parkinson's disease in subthalamic nucleus versus globus pallidus interna deep brain stimulation: the compare trial. Ann neurol, 2009; 65(5): 586-595. Summary: the study was a single-center, prospective, randomized, patient-and rater-blind, parallel-group trial that aimed to characterize and compare the effects of unilateral stn and unilateral gpi dbs on mood and cognitive function in patients with advanced pd. All patients were recruited, and some patients did not pass initial screening. A total patients were randomized to stn or gpi dbs. Forty-five patients completed the study. Reportable event: two cases of transient ischemic attack were reported. Symptoms occurred in both implant locations (stn and gpi). No patient treatment or outcome was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1425493
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
« Last Edit: February 07, 2015, 11:49:05 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #60 on: April 19, 2015, 02:54:22 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 7495lz51, serial# (b)(4) implanted: (b)(6) 2002, explanted: (b)(6) 2015, product type: extension. Product id: neu_unknown_lead, implanted: (b)(6) 2002, explanted: (b)(6) 2015, product type: lead. (b)(4).

Event Description
It was reported that the system was explanted due to an infection on (b)(6) 2015. Additional information indicated that the patient had a stroke and the deep brain stimulator system was explanted. No problems had existed with the deep brain stimulator technology or therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4580173
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #61 on: June 08, 2015, 06:54:07 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient had a seven year history of parkinsonism complicated by high dose use of entacapone and levodopa. The patient's implant of the system in the subthalamic nucleus was complicated by right frontal hemorrhagic stroke with bi-frontal injury evident on ct. The stroke resulted in left sided paresis and cognitive dysfunction amplified by two seizures. The patient was treated at ucsf. The patient was doing well with isolated control of parkinsonism and their health care professional (hcp) was monitoring their cognition.

Manufacturer Narrative
Concomitant products: product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead; product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead; product id 3708640, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3708640, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead; product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4755853
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #62 on: June 08, 2015, 06:54:48 AM »

Model Number 3387S-40
Event Date 04/20/2010
Event Type Injury
Event Description
It was reported the patient had a mini stroke and subsequent "bleen" when the lead was implanted. No outcome was 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
Product id: 37601, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: neu_ptm_prog, serial# unknown, product type: programmer. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4762603
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #63 on: July 15, 2015, 11:36:54 PM »

Model Number 3387S-40
Event Date 06/10/2015
Event Type Injury
Event Description
It was reported that there was an intracranial bleed that had occurred during the procedure for the lead implant. The lead was left in place when the patient had started showing signs of stroke and the case was aborted. Hospitalization was required. X-rays were done. A computerized tomography (ct) revealed a large bleed. The patient had signs of weakness on the contra lateral side and some facial drooping. The patient was admitted to the intensive care unit and at no point was surgical intervention planned. The patient was alive with injury. The intracranial bleed was 3cm in diameter. Patient symptoms at the lead location included headache, stroke, loss of reflexes and paralysis. Further follow-up is being conducted. If additional information is received a supplemental report will be submitted.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4875535
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #64 on: July 15, 2015, 11:37:36 PM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 3389s-40, lot# va05216, implanted: 2015 (b)(6); product type lead product id 3389s-40, lot# va05216, 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 that the patient had three epileptic or transient ischemic attack (tia) episodes in the last two months since the interstim device was on. The patient referred to tia as ¿mini strokes¿. Further follow-up is being conducted to obtain information. If additional information is received, a follow-up report will be sent. Information unrelated to this event was included in a several separate pes. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4871395
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #65 on: July 15, 2015, 11:38:31 PM »

Model Number NEU_INS_STIMULATOR
Event Type Death
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, implanted: (b)(6) 2012 product type: lead. Product id: neu_ins_stimulator, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4) product type; programmer, patient. Product id: 3387s-40, lot# v989563, implanted: (b)(6) 2012 product type: lead. Product id: 37085-60, serial# (b)(4) product type: extension. Product id: 3387s-40, lot# v911924, implanted: (b)(6) 2012, product type: lead. Product id: 37085-60, serial# (b)(4) product type: extension. (b)(4).

Event Description
It was reported that the patient was having two implantable neurostimulators (inss) placed in (b)(4) 2013. They had gone in and placed the 1st one, the patient had begun to bleed but had recovered from that. They had gone back in to revise the 2nd one and the patient had a bleed at the tip of the lead and had suffered a stroke a few hours later. The patient never recovered from the stroke. The patient died on (b)(6) 2013. The cause of death was not device related but had occurred during the procedure implant. Reference manufacturer¿s report number: 3007566237-2012-02621, for patient's similar issues that were experienced in (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4872134
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #66 on: August 08, 2015, 10:08:20 AM »

Model Number 37602
Event Date 06/08/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient product id: 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id: 3387-40, lot# j0343947v, implanted: (b)(6) 2003, product type: lead. (b)(4).

Event Description
It was reported that the patient had a mini stroke. The patient had a computerized axial tomography (cat) scan was done and it was believed to be related to the device along with the mini stroke. The patient had a doctor appointment scheduled on the day following the date of this report. There was also a bulging on the right side of the head where the wire was behind the ear. Further follow-up is being conducted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4908657
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #67 on: August 08, 2015, 10:08:54 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported the patient had a stroke and was going to have an mri. 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. Refer to manufacturer report #3004209178-2015-13997.

Manufacturer Narrative
Concomitant products: product id: 37601, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3387s-40, lot# v822991, implanted: (b)(6) 2012, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 3387s-40, lot# va0cl8j, 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. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4936198
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #68 on: September 07, 2015, 08:00:16 AM »

Model Number 7426
Event Date 12/01/2004
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2004, product type: implantable neurostimulator. Product id: 3387-40, lot# j0428226v , implanted: (b)(6) 2004, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 3387-40, lot# j0444274v, implanted: (b)(6) 2004, product type: lead. (b)(4).

Event Description
The consumer reported that few months after his 2004 bilateral implant, he got an infection under the skin and the left lead had to be pulled out. They waited 2-3 months for the infection to clear and they were putting in a new lead but they had to stop surgery. The patient had a stroke and brain bleed. He also had to go to rehab to learn how to walk again. The left lead was put in at a later time but the patient still suffered from migraines and headaches. The patient was indicated for movement disorders. No further information was provided. If additional information is received, a follow-up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4994759
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #69 on: September 07, 2015, 08:01:12 AM »

Model Number 7426
Device Problem No Known Device Problem
Event Type Injury
Manufacturer Narrative
Product id 7482a51, serial# (b)(4), implanted: 2009 (b)(6); product type extension product id 3387s-40, lot# v255260, implanted: 2009 (b)(6); product type lead. (b)(4).
Manufacturer Narrative
(b)(4).

Event Description
Additional information from the consumer noted that the patient had an ocular stroke and was blind in one eye. The patient did not know what led to it, she woke up in the morning and she could not see. The patient did a study on 2015 (b)(6) where the events were first noted. The indication for use is essential tremor. No further information was provided.

Event Description
It was reported that the patient had a stroke approximately one year prior ((b)(6) 2014). No interventions, diagnostics, 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4960698
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #70 on: September 07, 2015, 08:01:57 AM »

Model Number 37612
Event Date 07/15/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 748240, serial# (b)(4), implanted:(b)(6) 2007, product type: extension. Product id: 3387s-40, lot# v015069, implanted:(b)(6) 2007, product type: lead. Product id: 748240, serial# (b)(4), implanted:(b)(6) 2007, product type: extension. Product id: 3387s-40, lot# v021705, implanted:(b)(6) 2007, product type: lead. Product id: 37651, serial# (b)(4), product type: recharger. (b)(4).

Event Description
The health care provider (hcp) reported via the company representative that there was a ¿patient with a stroke. ¿ it was later stated that the patient had been admitted to the hospital on (b)(6) 2015 with ¿stroke like symptoms¿ and they wanted the company representative to come and check the device to rule that out as a possible problem. Therapy impedance was checked and all values were within normal range. In addition, the battery had been in full time use since the previous (b)(6), and the patient reportedly charged their battery every other day and kept it above the 50% range. No interventions/actions were noted to have been taken to resolve the issue, but it was unknown if the issue had resolved. It remained unknown what led to the event or how the issue was identified. Further follow-up for diagnostics, actions/interventions, and patient outcome is being conducted. If additional information is received, a follow-up report will be sent. Indications for use: parkinsons dual movement disorders.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4966301
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #71 on: September 07, 2015, 08:03:10 AM »

Model Number 37602
Device Problem No Known Device Problem
Event Date 07/08/2015
Event Type Death
Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted:(b)(6) 2014, product type: implantable neurostimulator. Product id: 3389s-40, lot# v079662m implanted:(b)(6) 2008, product type: lead. Product id: 7482a51, serial# (b)(4), implanted:(b)(6) 2008, product type: extension. Product id: 3389s-40, lot# v079662, implanted:(b)(6) 2008, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 7482a51, serial# (b)(4), implanted:(b)(6) 2008, product type: extension. (b)(4).

Event Description
The healthcare provider (hcp) reported that the patient had an unrelated hip surgery on (b)(6) 2015, after which the patient suffered a stroke overnight. Her indications for use were parkinson¿s dual and movement disorders. The hospital was considering moving her to hospice. The hcp did not know if the stroke had anything to do with the therapy and noted there was a risk of stroke with all surgery. The hcp was calling in because the patient¿s implantable neurostimulators (ins) were turned off for the surgery and needed someone to turn stimulation back on. The patient¿s family did not know how to work the programmer and the hcp could not be responsible for it. A manufacturer representative (rep) later reported that the patient was seen and she may have turned the inss on herself after the surgery. She apparently had her programmer with her at the time and when the rep went to turn them back on, they were already on. It was unclear if the stroke was device or therapy related and the patient outcome was not reported, so additional information was requested. If additional information is received a supplemental report will be sent. Refer to manufacturing report #(b)(4) as the patient had two inss.

Event Description
Additional information received from a health care provider (hcp) reported the patient did not have an mri, instead they had two brain ct scans done. Both ct scans came back negative for stroke. The patient's neurologist reviewed the ct scans again and said the scans showed a stroke. The cause of the stroke was not determined, but the patient had surgery and the hcp felt that was a risk factor. No actions or interventions were taken. The patient had a fatal stroke and there was nothing that could be done. The patient was put on dnr/hospice and they passed away on (b)(6) 2015.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4976801
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #72 on: September 07, 2015, 08:03:56 AM »

Model Number 37602
Event Date 07/17/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37602, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 3389s-40, lot# v062134, implanted: (b)(6) 2007, product type: lead. (b)(4).

Event Description
The consumer reported that the patient had a ¿clot¿ near where the stimulator was located. The patient suffered a stroke and was now completely paralyzed. The patient had a feeding tube because they could not swallow and could not speak. The patient¿s wife had turned the device off and stated it would not be turned on again. The results of any diagnostic testing were not provided and the patient¿s ultimate outcome remains unconfirmed. Follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent. Indication for use: parkinsons dual <(>&<)> movement disorders.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4976978
Logged
Pages: 1 2 3 [All]   Go Up
Print
Jump to: