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Author Topic: Deep brain stimulator - Falls  (Read 37805 times)
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dennis100
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« Reply #30 on: January 18, 2014, 06:42:05 AM »

Model Number 7426
Device Problems Intermittent continuity; Electro-magnetic interference (EMI); Inappropriate shock
Event Type  Malfunction 
Event Description
It was reported that the patient's implantable neurostimulator turned itself off. The patient experienced a return of shaking on the right side of their body and turned on the left stimulator and experienced a shocking sensation and a backache. The patient expressed feeling the shocking sensation on the rods in their back. It was also reported that the shocks caused the patient to sleep for 2 1/2 hours. Additionally it was reported that the patient had the sensation of surging energy when their head was turned a certain way and when going through store security. The patient had suffered a fall from tripping on a footstool 4-5 months prior to 2009. Additional information has been requested, but was not available as of the date of this report. Refer to manufacturer's report #6000032-2009-02818.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1430443
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dennis100
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« Reply #31 on: January 18, 2014, 07:04:30 AM »

Model Number 7428
Device Problem Replace
Event Date 03/11/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient's stimulation has not worked since falling 3 weeks ago. After falling the patient was able to "pull-up" on the neurostimulator and the stimulation would work. The extension was replaced and the stimulation worked again. It was noted that the extension was cut during explant so it was able to be removed. There were no patient injuries and the patient recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1357803
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dennis100
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« Reply #32 on: January 18, 2014, 11:59:45 PM »

Model Number 7426
Device Problem Failure to interrogate
Event Date 04/01/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that the patient experienced a loss of therapeutic effect following a fall. It was also reported that the patient could not interrogate the left implantable neurostimulator. An x-ray of the implantable neurostimulator and the extension area was recommended. Additional information has been requested, but was not available as of the date of this report. Reference manufacturer's report #3004209178-2009-03770.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1458877
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dennis100
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« Reply #33 on: January 19, 2014, 12:00:23 AM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1427975
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dennis100
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« Reply #34 on: January 19, 2014, 12:02:45 AM »


Model Number 7426
Device Problem High impedance
Event Date 01/01/2008
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
The patient fell. Six months later, he was seen in clinic and impedances greater than 2000 ohms were seen on all bipolar and unipolar electrode combinations. The device was programmed to use case + 1-, which had a current of 49 microamperes. Current on all other combinations was low (9-16 microamperes). There were no therapeutic changes. Additional information has been requested. A follow-up report will be submitted if additional information becomes available. Please see mfr report # 3004209178-2009-03753.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1455850
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dennis100
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« Reply #35 on: January 19, 2014, 12:03:18 AM »

Model Number 7426
Device Problems Material frayed; Inappropriate shock
Event Date 01/01/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that the pt experienced a fall and landed directly on their implantable neurostimulator which was implanted in her chest. The pt states that they felt a shocking or jolting sensation and a tingling sensation near the implantable neurostimulator site and that their throat closed up "when they made reprogramming adjustments". Additional info rec'd reported that the pt turned off her stimulator since the shocking and jolting sensation occurred. The pt's physician surmised that the closing throat event may be the result of "wider pulse width causing muscular constriction which seems to be removed with programming alterations". A frayed lead was suspected but not confirmed. X-rays were performed but the results were not available at the time of this report. Refer to mfr report# 3004209178-2009-03604.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1449777
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dennis100
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« Reply #36 on: January 19, 2014, 12:03:55 AM »

Model Number 7426
Device Problem Device stops intermittently
Event Date 01/01/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
For the last month and a half, the right implantable neurostimulator (ins) was turning off by itself. It turned off three times on (b) (6) 2009. There was no new technology or emi in the patient's home and there was no known accident or incident related to the event. It was noted that the patient fell frequently. The last time the patient went in to the neurologist, one of her implantable neurostimulators had been off for approximately 6 hours and the patient hadn't noticed it; it was unclear which ins had been off. The neurologist indicated that the battery was fine. The patient's husband said they can tell the ins was turning off because the patient noticed it right away. The healthcare professional reported that on interrogation it showed that in the last three weeks, there were six activations and a 100 hour difference between the two devices. Impedances looked good. The patient had not done anything different; she turned it off when in bed and when she was on the couch. Additional information has been requested, a follow-up report will be sent if additional information becomes available. See manufacturer's report number: 3004209178200904420.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1459277
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dennis100
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« Reply #37 on: January 19, 2014, 12:04:36 AM »

Model Number 7426
Device Problems Material frayed; High impedance; Migration of device or device component; Replace
Event Date 12/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
All contacts on the left brain lead had open circuits. The wiring was frayed/pulled on the brain lead side as opposed to battery side, resulting in repeat brain surgery to replace the lead. Additional information has been requested, a follow-up report will be sent if additional information becomes available.

 
Manufacturer Narrative
 
Manufacturer Narrative
 
Event Description
Additional information received reported the patient had a few falls, but there was no injury and there was no device issues. The lead had fractured and migrated in (b)(6) 2008 and the implantable neurostimulator was replaced. The cause of the break was unknown. Additional information received reported the system was fine after it was revised on (b)(6), 2009.

 
Manufacturer Narrative
(b)(4).

 
Event Description
Additional information from the patient¿s wife that reported, the patient required two separate surgeries to replace the broken and migrated lead. It was originally thought the fracture may have occurred at the extension connection site, but it was later found that the lead had fractured further up. The patient¿s wife stated that the doctor ¿couldn¿t find the sweet spot¿ so the surgeon removed the entire system. The patient was reimplanted during a second surgery. 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=1411929
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dennis100
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« Reply #38 on: January 19, 2014, 04:46:27 PM »

Model Number 7426
Device Problem Implant, reprogramming of
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient's implantable neurostimulator system was alleviating the patients shaking, but caused speech issues and "too much flexibility" in the patient's legs. It was reported that patient had fallen numerous times and had recently fallen and broken her shoulder. Additional info has been requested from the hcp, but was not available as of the date of this report. Refer to manufacturer's report 3004209178-2009-04223.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1404951
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dennis100
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« Reply #39 on: January 19, 2014, 04:47:00 PM »

Model Number 7426
Device Problem High impedance
Event Date 01/01/2008
Event Type  Malfunction 
Event Description
It was reported that the patient had multiple falls since october of 2008. The patient experienced a loss of efficacy (which was claimed to be unrelated to stimulation therapy) and impedances >2,000 ohms. An x-ray of the lead area revealed no lead breaks. Additional information revealed that the patient experienced "fizzy" feelings of the head and double vision along with difficulty walking with electrode 1 programmed. The following impedances were measured: c0:721 ohms 74ua, c1:>2,000 ohms <7ua, c2:721 ohms 74ua, c3:714 ohms 74ua, 01:>2,000 ohms <7ua, 02:1113 ohms 55ua, 03:1109 ohms <51ua, 12:>2,000 <7ua, 13:>2,000 ohms <7ua. Additional information has been requested, but was not available as of the date of this report.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1471574
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dennis100
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« Reply #40 on: January 19, 2014, 04:47:54 PM »

Model Number 7428
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Impedance problems - other: dystonia.

 
Event Description
It was reported that following a revision, the patient experienced a loss of therapeutic effect; dystonia was worse, cognitive changes, gait instability, and a fall. A ct scan showed no problems. Problems with impedances were reported. Channel one was ok. Channel two was questionable. Four and case, seven and case = 690 ohms with current less then 15. All bipolars = 690 ohms with current less then 15. 5 & case and 6 & case = 452 ohms with current greater than 19. 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=1400256
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dennis100
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« Reply #41 on: January 19, 2014, 04:48:25 PM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1494706
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dennis100
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« Reply #42 on: January 19, 2014, 04:49:25 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
It was reported that the pt fell on the back of their head and experienced a loss of efficacy. He was admitted to the hospital. Further info is being requested from the hcp.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1443489
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dennis100
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« Reply #43 on: January 19, 2014, 11:07:20 PM »

Model Number 7426
Device Problem High impedance
Event Date 02/01/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
The patient experienced a loss of therapeutic effect following a fall. The patient was seen in clinic. The unipolar impedance between the case and electrode 0 was greater than 2000 ohms. Additional information has been requested. A follow-up report will be submitted if additional information becomes available. Reference mfr. Report # 300420917820095055.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1418499
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dennis100
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« Reply #44 on: January 21, 2014, 12:06:42 AM »

Model Number 7426
Device Problem Device operates differently than expected
Event Date 05/01/2009
Event Type  Malfunction 
Event Description
The patient had experienced several falls since having a seizure in (b) (6) 2009. Afterward, was unable to walk and talk while deep brain stimulation was on. When stimulation was turned off during a colonoscopy, he was able to speak. He was also able to walk without falling when it was off. Please see mfr report #3004209178200909121. 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=1563072
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dennis100
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« Reply #45 on: January 21, 2014, 12:08:40 AM »

Model Number 7426
Device Problem No Information
Event Date 06/29/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported the patient experienced a catatonic contraction with her head and shoulder - leaning to the right. The hcp felt that the patient experienced an element of dystonia in the neck area that was not present prior to the implant. The muscle contractions were significant enough that it was interfering with the patient's gait, and has caused her to fall several times. A botox injection improved things slightly. The patient's device was reprogrammed and had another reprogramming appointment scheduled for the following week. 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=1563088
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« Reply #46 on: January 21, 2014, 12:10:18 AM »

Model Number 7426
Device Problem No Known Device Problem
Event Date 10/31/2009
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Literature: toda h, sawamoto n, hanakawa t, et al. A novel composite targeting method using high-field magnetic resonance imaging for subthalamic nucleus deep brain stimulation. J neurosurg. 2009;111(4):737-45. Summary: this article presents a prospective study of 26 consecutive bilateral stn deep brain stimulation implants for patients with advanced parkinson disease. The patients were randomly assigned to either the 3-t mr imaging group or the 1. 5-t mr imaging group. Thirteen patients underwent 3-t preoperative imaging, and 13 patients underwent 1. 5-t mr imaging. The hypothesis of the study was that the targeting accuracy could be improved by the use of high-field mr imaging (3-t) and a modified composite targeting method. Reportable event: one patient in the 3-t group experienced a humeral fracture due to a fall. No patient treatment or outcome was reported. The relationship of the fall to the implanted system was not reported. Reference mfr report #3007566237-2009-09010.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1562559
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« Reply #47 on: January 22, 2014, 07:12:32 AM »

Model Number 7426
Device Problem Device operates differently than expected
Event Date 12/28/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Following a fall, the patient had no stimulation. The doctor checked telemetry and it showed "below 7 ua at the settings of can (+) and 2 (-)". "battery status showed ok. " the implantable neurostimulator was replaced and the stimulation came back at the settings of can (+) and 2 (-). The patient's status was reported as "no health hazard".

 
Manufacturer Narrative
(b) (4) - the implantable neurostimulator (ins) has been returned to the manufacturer for analysis. A follow-up report will be sent when the analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1591764
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« Reply #48 on: January 22, 2014, 07:13:55 AM »

Model Number 7426
Device Problem Low impedance
Event Date 12/01/2009
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
The pt had surgery and went home; the reason for the surgery was not specified. The pt lived in a nursing home. The pt ended up falling and went back in the hosp. The healthcare provider was not sure whether the implantable neurostimulator had been turned off and if that was "causing all". It was noted that the pt had lost his pt programmer. Impedance measurements were checked and it was believed that the pt had an open circuit. The stimulator was shut off at that time because the neurologist was concerned about depleting battery. After the stimulator was shut off, the pt's family noticed he was having greater difficulty moving around and greater difficulty with hand dexterity. The pt had some dementia so, could only provide very limited input as to therapy benefit. The pt was referred for further investigation of the impedance issue. In (b) (6) 2010, impedance measurements were reported to be <250 ohms; <50 ohms was noted on combo of 0-1. The pt was programmed to 3-, 2-, 1+ with therapy impedance of 480 ohms, 32ua; 2. 5v, 60us, 185hz. All other impedances were within normal range. Since contacts 0-1 were not programmed together, it was felt that it wouldn't be a concern. The stimulator was turned back on during the visit and the pt appeared to be getting some benefit. Add'l info has been requested, a follow-up report will be sent if add'l info becomes available. See also mfr's report # 3004209178-2010-00543.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1591982
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« Reply #49 on: January 22, 2014, 07:15:19 AM »

Model Number 7428
Device Problem Device operational issue
Event Date 12/22/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
The patient was seen for consult on (b) (6) 2009 and the battery ok. It was also checked with the pt programmer on (b) (6) 2009 and was ok. On (b) (6) 2009, the pt was found lying on the floor. No telemetry was possible. The pt fell because the therapy was no longer effective. There was emergency hospitalization with ipg replacement. The device parameters were: r 2. 7v, 60 mcs, 160 hz, 2-; l 3v, 60 mcs, 160 hz, 5- "tension 2. 48v; residual capacity: 80 a 90". The pt was re-implanted and was "ok".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1590189
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« Reply #50 on: January 22, 2014, 07:16:41 AM »

Model Number 7428
Device Problems Device operates differently than expected; Impedance issue
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported, the pt was moving very slowly. There was a problem with the impedance values. The pt was referred for a consult and possible adjustment. Add'l info received indicated, the event was suspected to be attributed to the location of the lead. The cause of the event was unclear; but may be related to the programmed settings. The pt experienced cognitive changes, flat affect, and symptoms of early dementia. Reprogramming was done. A contact was deleted in the superior zona incerta region to improve the patient's gait. A prescription for galantamine was added. Office notes indicated, the pt festinated in small spaces. The pt had fallen, however, walked ok when out and about. In 2009 at the time of the visit, the pt had a good long stride, good bilateral arm swing, fair balance on pull testing. The pt was very hypophonic. Contact 7 was deleted during programming, as the pt may have had worsening of his gait from this contact. It was initially added to control stim related dyskinesias, but perhaps those had since resolved or were less bothersome. It was reported over the last 9 months, the pt had multiple falls (>15). The pt reported having difficulty moving around for quite awhile, however, it had gotten to the point his feet buckle and he can't regain balance and falls over if there is nothing to catch him. The patient denied any precipitating factors or patterns. The pt denied any lightheadedness, dizziness, palpitations, mental lapses, loss of consciousness, or feelings of weakness associated with the falls. The pt reportedly broke a ribe during one of the falls and that he temporarily lost consciousness (10 seconds) during another episode where he fell in a parking lot. The pt had no residual pain/problems related to the falls. The pt also presented with worsening cognitive decline. The pt and his wife believed his memory was declining and he got confused easily, both of which had gotten progressively worse for the last 6-8 months. The pt had a "depressive mood" which was being treated with venlafaxine, which his wife describes as a lack of motivation. The pt reported he "feels terrible" but was unable to describe the symptoms further. Along with his wife, the pt questioned if it was related to worsening pd or if this was a new problem. No functional problems were reported with the dbs unit, however, a technician had indicated the unit was not working as "efficiently as it could. " the pt's cognitive symptoms were consistent with the onset of dementia seen in pd. Given the new onset, the pt was recommended to start on galantamine and monitor for response. The pt also underwent changes to medications for the depressive symptoms. Medications: sinemet, venlafaxine, allopurinal, asa, simvastatin, lisinopril, vit b12, docusate.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1580214
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« Reply #51 on: January 27, 2014, 02:24:07 AM »

Model Number 37603
Event Date 11/20/2013
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
It was reported that the patient fell after programming. The patient was programmed by the healthcare professional (hcp) on (b)(6) 2013. The patient¿s family member reported that they fell later that night while walking to their car after shooting pool. The family member believed the implantable neurostimulator (ins) was responsible for the patient¿s fall. It was reported that the fall was caused by the stimulation. It was noted that hospitalization was required as a result of the event. The patient had a broken humerus and broken ribs. The patient¿s status was alive with injury. Diagnostics included impedance testing and impedance was normal before and after the fall. It was further reported that the caller stated the patient had the ins therapy ¿installed¿ one day prior to report. The caller stated the patient went out, drove, shot pool and fell down and broke two of their ribs, their femur bone and their shoulder on their ¿good arm¿ that the ins therapy was helping. The caller stated that the day prior to report was the first day the patient had the therapy turned on. The caller stated they thought the fall was related to the ins therapy. The patient also thought the ins may have caused the fall. The caller stated the patient felt like they were ¿going downhill real fast¿ and they tripped and fell even though the street was level. The caller also stated the patient had a ¿bad¿ knee and was also taking antibiotics for a problem with infection for their wrist. It was confirmed that the knee and wrist problems existed prior to the ins implant. The caller stated that the patient was currently in the hospital and in ¿bad shape. ¿ the caller also stated they turned the patient¿s stimulation off in case they needed to have an x-ray or other diagnostics taken. The caller was redirected to the patient¿s hcp. Additional information was requested but was not available at the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3503791
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« Reply #52 on: January 27, 2014, 09:41:27 AM »

Model Number 7428
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Product id 7482a40, serial# (b)(4), implanted: 2007 (b)(6); product type extension product id 748240,serial# (b)(4), implanted: 2007 (b)(6); product type extension product id 7436, serial# (b)(4), implanted: 2007 (b)(6); product type programmer, patient product id 3387s-40, lot# v025540, implanted: 2007 (b)(6); product type lead product id 3387s-40, lot# v013081, implanted: 2007 (b)(6); product type lead. (b)(4).

Event Description
It was reported, the patient had a loss of therapeutic effect. It was noted that for the past three weeks, the patient had been falling again and they were not steady on their feet. It was further noted that three weeks ago the patient fell out of bed and broke their nose. The reporter stated, the other day they fell and broke their glasses. The reporter further stated there was not a pattern in terms of direction the patient was falling and it just depended on the situation. It was noted the patient was scheduled to see their healthcare professional on 2013 (b)(6). It was further noted the patient had their implantable neurostimulator (ins) checked last (b)(6) and they had 30% battery left. The reporter stated they were scheduled for a replacement in (b)(6). Additional information was requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3533765
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« Reply #53 on: January 28, 2014, 09:22:28 AM »

Model Number 37601
Device Problem Low impedance
Event Date 11/22/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).

 
Manufacturer Narrative
Lead model 3389s-40, lot # v333260, implanted: (b)(6) 2009, explanted: na; lead model 3389s-40, lot # v276341, implanted: (b)(6) 2009, explanted: na; extension model 37085-60, serial # (b)(4), implanted: (b)(6) 2009, explanted: na; extension model 37085-60, serial # (b)(4), implanted: (b)(6) 2009, explanted: na; programmer model 37642, serial # (b)(4). The initial mdr was filed as mfr report # 3007566237-2010-10148. Additional review indicated the correct manufacturing site was site (b)(4).

 
Event Description
Additional review determined that the previously reported event occurred in (b)(6).

 
Event Description
Additional information received from the hcp reported that the patient had increased amplitude by 0. 1 on each lead. Afterwards, the patient felt that his balance had become worse, he had increased in falls, and he generally did not feel well. It was noted that the patient had also recently reduced his medications. The patient had turned the device off at the request of his hcp. The patient then visited his hcp for an interrogation, which showed that contact pair 8-9 had an impedance of 32 ohms. Contact pair case 2 on had an impedance of 84 ohms. The hcp traced back the patient's records and saw that the short on contact pair 8-9 had existed since (b)(6) 2009. X-rays were taken on (b)(6) 2010 and (b)(6) 2010, but the leads appeared intact and there were no obvious breaks. The patient's voltage was reduced to its previous level, but no further reprogramming was done as the contact pairs with the low impedances were not used in the patient's programming. It was reported that the patient did not require hospitalization, and there was no patient injury.

 
Event Description
Impedance between contacts 8 and 9 was 35 ohms. Using case, 8 or case, 9 and voiding the 8, 9 combination in programming was discussed. It was unk if reprogramming addressed the pt's therapy needs.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1937775
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dennis100
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« Reply #54 on: February 07, 2014, 12:32:42 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
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dennis100
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« Reply #55 on: February 07, 2014, 07:09:27 AM »

Model Number 37602
Event Type  Injury   Patient Outcome  Disability
Manufacturer Narrative
Product id 37602, serial# (b)(4), implanted: 2013 (b)(6); product type implantable neurostimulator product id 748351, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3387s-40, lot# unknown, implanted: 2013 (b)(6); product type lead product id 3387s-40, lot# va01mbs, implanted: 2012 (b)(6); product type lead product id 748351, serial# (b)(4), implanted: 2012 (b)(6); product type extension. (b)(4).

 
Event Description
It was initially reported (b)(6) 2013 that therapy had been effective in treating the patient¿s tremors but it made walking more difficult. The patient was very disappointed with the results of deep brain stimulation therapy and since having her first implant on 2012 (b)(6). The patient has had difficulty walking without a walker and after the second implant on 2013 (b)(6) the difficulty walking got worse. The patient had 4 falls yesterday and fell almost every day. It was noted, the patient was taking less medicine and her health care provider (hcp) considered therapy a success. It was later reported on (b)(6) 2013 that the patient had ¿bad¿ results with the device therapy for parkinson¿s. She falls ¿all the time¿ and she was ¿very unstable¿. The patient wanted a list of physicians since her hospital did not seem to want to change her programming. It was further reported that the patient was still having concerns but was working with her hcp/company representative. The patient had an upcoming appointment on 2013 (b)(6). Additional information received reported the patient never had therapeutic effect. The patient was disgusted with the results of her deep brain stimulation (dbs) procedure; she was disgusted that her condition did not improve and it got worse. The patient could hardly walk, could not stand up, and her voice was bad. The patient walked into surgery and was now in a wheelchair. Additional information has been requested but was not available as of the date of this report; a follow-up report will be sent if information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3555091
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dennis100
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« Reply #56 on: February 07, 2014, 07:40:22 AM »

Model Number 37602
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
It was reported, the patient was having a return of symptoms after several falls. The reporter stated, the symptoms were not visible and the patient¿s wife reported not feeling the same which they thought was due to some falls. It was noted, the patient had been experiencing hallucinations and cognitive issues for the past couple of months. It was further noted, the manufacturing representative suggested that may be the reason for the falls. The reporter stated, the patient fell on 2013 (b)(6) and 2013 (b)(6). It was noted that one fall affected the patient¿s head and they had an open wound. It was further noted that the patient¿s head wound was not on the side of the questioned impedances. The reporter stated, the patient was admitted to the hospital currently since sunday. The reporter further stated, the reason for arriving at the hospital because, the patient was stressed and panicked and their wife could no longer transfer them from the wheel chair to a toilet. It was noted, the patient was ¿in a walker. ¿ the reporter stated, the patient had been declining since all of the falls. It was noted, the patient had not been able to follow-up with their healthcare professional (hcp) to inquire about affected therapy benefit. It was noted, the patient was programmed with c and 1 on the right side. It was further noted that impedances for c3, 03, 13, and 23 were greater than 4000 ohms. The reporter stated they were unsure of base line or prior impedances. It was noted the implantable neurostimulator (ins) voltage on the right side was 2. 67v and the left side ins was 2. 75 v. Additional information received reported, the patient¿s therapy had been compromised since their fall. It was noted, the patient was last seen six months ago by a hcp and the patient currently has no managing hcp. The reporter stated, the patient had hallucinations and cognitive issues so it was difficult to assess therapeutic response to programming. It was noted, the patient was mostly sleeping. It was noted that therapy impedances were measured to be 791 ohms. It was further noted that when the patient fell it was on their left cap and side of their head. Additional information was requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3568547
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dennis100
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« Reply #57 on: February 07, 2014, 08:23:26 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported that the patient had experienced "another fall" and broke her sacrum and some other bones in her back. Additional information has been requested but was not available as of the date of this report. When received, a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3589600
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dennis100
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« Reply #58 on: February 07, 2014, 08:25:03 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v333244, implanted: (b)(6) 2009, product type lead; product id 3389s-40, lot # v333244, implanted: (b)(6) 2009, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension. (b)(4).

 
Event Description
It was reported the patient was in the icu and was being treated for a fall that resulted in hematoma (left, frontal around 1-2 mm).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3590158
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dennis100
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« Reply #59 on: April 10, 2014, 08:07:39 AM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3677018
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