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Author Topic: Deep brain stimulator - Falls  (Read 37804 times)
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dennis100
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« on: January 13, 2014, 09:26:10 AM »

Model Number 7424
Device Problems Loss of power; Low battery
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
Journal reference: anheim m, fraix v, chabardes s, krack p, benabid a-l, pollak p. Lifetime of itrel ii pulse generators for subthalamic nucleus stimulation in parkinsons disease. Mov disord 2007; 22 (16): 2436-2439.

 
Event Description
Journal reference: anheim m, fraix v, chabardes s, krack p, benabid a-l, pollak p. Lifetime of itrel ii pulse generators for subthalamic nucleus stimulation in parkinsons disease. Mov disord 2007; 22 (16): 2436-2439. The article describes the results of a long term study where 49 pts were treated for symptoms of advanced parkinsons disease with bilateral deep brain stimulation (dbs) of the subthalamic nucleus (stn). The purpose of the study was to evaluate the lifetime of chronic stimulators (itrel ii). A number of adverse events related to stimulator end-of-life (normal battery depletion) were included in the article. Unilateral ipg end-of-life to sudden and severe aggravation of parkinsonian symptoms in 10 pts. Unilateral ipg end-of-life led to falls in four pts. No additional info concerning treatment and outcome was provided.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008127
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dennis100
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« Reply #1 on: January 13, 2014, 11:07:35 AM »

Model Number 7482
Device Problems Dislodged; Replace
Event Date 01/24/2008
Event Type  Malfunction   Patient Outcome  Required Intervention,Hospitalization
Event Description
The hcp reported, the pt had the pulse generator replaced in 2007 without complications. When the pt went to the clinic in early 2008, he complained of draining of his right chest pulse generator site. He was examined and it was found that the pulse generator moved from the right chest area to just below the shoulder. The pt had erythema, bruising and drainage of the pulse generator site. He had laboratory testing to determine if the area was infected. The laboratory tests were negative. On the same month, the right side pulse generator and extension wires, which had dislodged, were removed to prevent infection. The pt was admitted to the hosp, given iv antibiotics, and tissue and blood cultures were taken. The final cultures were negative and the patient was discharged home without any further antibiotics. On the following month, a pulse generator was re-implanted in the lower right abdomen and extension wires placed in the right-sided neck and scalp area and the dbs system was turned back on. The patient was seen by the surgeon eight days later, to have staples removed. The prior ipg wound site and the new incision sites had healed well and the adverse event had resolved. The pt had recovered without sequela. The hcp reported the pt had also reported falls (dates were not provided). A follow-up report will be sent if additional info becomes available.

 
Manufacturer Narrative
Results of final device analysis were not completed at the time of this report. A follow-up report will be sent when product evaluation has been completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1014726
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dennis100
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« Reply #2 on: January 14, 2014, 12:09:44 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 08/23/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the pt had a return of symptoms that was not controlled by the stimulator system. The pt had a difficult time walking and fell on a saturday and sunday. The pt did not land on her device side. The pt felt tingling when the stimulator was turned on. The tingling occurred in both her fingers and her feet. The pt was at home at the time of the report; the pt status was undetermined. The pt was directed to contact the physician. Add'l 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=1178927
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dennis100
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« Reply #3 on: January 14, 2014, 12:10:16 PM »

Model Number 7428
Device Problems High impedance; Device remains implanted
Event Date 08/01/2008
Event Type  Malfunction 
Event Description
It was reported the patient had a loss of efficacy that occurred about 3 months ago. The patient's wife reported he had fallen 3 times recently. Impedance checks reported right brain impedances were over 4000 ohms<15ua. When amplitudes were changed and tested at 4 volts, there were two combinations that were similar; electrodes 4 & 5 and 5 & 6 were 1883 ohms. The patient was getting some efficacy. The left brain impedance was tested and all pairs were 1395 ohms<15ua. Retesting at 4 volts amplitude showed the same results. Manufacturer's representative suggested palpating and x-ray. Additionally, it was noted the patient had a burr hole removed two weeks prior. No additional symptoms or outcome were reported. 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=1180995
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dennis100
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« Reply #4 on: January 14, 2014, 12:10:47 PM »

Event Date 01/01/2008
Event Type  Malfunction   Patient
Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported the pt stated the extension leads feel tight bilaterally in her neck. During her seventh programming session with the hcp, the pt reported interim history that she had been falling once a week. One instance left her badly bruised and went to the emergency room for assessment. She becomes easily fatigued and cannot stand up for long periods of time. She had been drooling on the right side of her mouth. She had been having nightmares and hit out at others in her sleep. Following the reported programming session, the pt showed improvements in symptoms with a negative wilson's bilaterally, finger to thumb movement was easier to the right, increased ability to lift her right foot, and slight arm swing bilaterally. The pt was seen at a later date by the neurosurgeon. The pt reported the neurosurgeon suggested she turn off the generators to see if she had benefited from the programming. After 25 minutes, the pt experienced some increase in rigidity, but no tremor. It was then programmed at the original settings with instructions to turn off at home for a longer trial. The neurosurgeon reported the pt experienced emotional changes along with the pain and tightness in the neck and head. The pt was offered a revision of the extensions. The pt was given a ten units to assist with back pain. The hcp recommended contacting the mfr to see if it would interfere with the generators. The pt's concomitant medications noted were: sinemet, azilect, zoloft, trileptal, neurontin, and b12 injections. The hcp stated the azilect may be aggravating her sleep disturbance and increasing her nightmares when taken at night. No injury was reported. No further outcome was reported. Add'l info has been requested, a follow-up report will be submitted if add'l info becomes available. Please see mfr. Report #3004209178-2008-03202.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1061470
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dennis100
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« Reply #5 on: January 14, 2014, 12:36:20 PM »

Model Number 7426
Device Problems High impedance; Implant, reprogramming of
Event Date 06/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The health care professional (hcp) reported that the pt had several falls and was not getting good therapeutic results. Impedances were checked and found to be >2000 ohms on all or some of the unipolar pairs. The stimulator was reprogrammed and the pt appeared to be getting better results. Add'l info has been requested, a follow-up report will be sent if add'l info becomes available. See manufacturer's report #3004209178-2008-04317.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1083106
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dennis100
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« Reply #6 on: January 14, 2014, 12:36:52 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 12/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the pt has been experiencing more "off time" which has been steadily increasing since early december. It is unknown if it is device related or the progression of his parkinsons disease. It was also reported the pt has been experiencing some falling incidences. No dates or injuries were reported. See mfr report # 3004209178-2008-04431. Additional info has been requested but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1081345
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dennis100
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« Reply #7 on: January 14, 2014, 09:44:08 PM »

Model Number 7428
Device Problem Explanted
Event Date 04/03/2008
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
Final device analysis of the deep brain stimulator revealed no anomaly - the device was functionally ok. Lead# 1 model 3387. The lead was cut through and segmented. The conductors were severely stretched at the proximal end of the lead and the 0 contact was broke (suspected overstress damage). Lead #2 model 3387. The lead was cut through and segmented when received. Extension model 7482. The extension was ok but cut through (suspected explant damage). Final device analysis revealed no significant anomalies. Stimloc. One stimloc base, clip and cap were returned with no anomalies. One other base was returned that was broken apart.

 
Event Description
It was reported that the pt had developed a scab four months ago over the right-sided cranial implant site; the pt suffered reported falls and trauma injury to the head (hitting his head), over a three month period. There was a progression of the scalp wound erosion resulting in infection with symptoms of intermittent fevers and drainage. The pt was diagnosed with staphylococcus aureus (mssa), and septic arthritis after completion of wound cultures and unspecified laboratory testing. He was admitted to the hospital for eval and treatment with oral antibiotics. Inspection showed the scab was loose from the scalp with underlying "whitish" tissue; there was slight drainage from the wound and no exposed wire was visible. The other dbs surgical sites had been deemed intact. The system was explanted; after removal of the lead and extension products, the pulse generator was explanted four days later. The event was attributed to the pt condition and included risk factors of another primary infection, orthopedic limitations from parkinson's disease and from pt induced "picking at the implant site". The pt was expected to recover. Refer to mfr report# 6000153200802465, 6000153200802464 and 6000153200802463.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1176146
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dennis100
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« Reply #8 on: January 14, 2014, 09:44:46 PM »

Model Number 7426
Device Problems High impedance; Implant, reprogramming of
Event Date 08/26/2008
Event Type  Malfunction 
Event Description
The patient had several falls. All bipolar electrode combinations except case-1, case-3 and 1-3 had impedances greater than 2000 ohms with a current less than 7 microamperes. The hcp programmed the device to case+, 3-. The hcp planned to do x-rays. No patient symptoms were reported. The deep brain stimulator was located in the patient's abdomen. Additional info has been requested. A follow-up report will be submitted if additional info becomes available. Please see mfr. Report # 3004209178200806024.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1176146
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dennis100
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« Reply #9 on: January 14, 2014, 10:24:56 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 08/01/2008
Event Type  Malfunction 
Event Description
The patient experienced increased tremor following a fall. Device troubleshooting showed the batteries of the programmer were ok. The deep brain stimulator was on. 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=1172114
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dennis100
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« Reply #10 on: January 14, 2014, 11:19:42 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Literature: farris sm, giroux ml. Gait changes after deep brain stimulation for parkinson's disease in a pt with cervical myelopathy. Neurorehabilitation. 2008;23(3):263-265. We present a male pt with significant gait problems due to parkinson's disease who underwent stn dbs. Gait worsened after surgery despite significant improvements in parkinsonian signs, due to underlying spasticity previously overshadowed by his parkinsonian motor symptoms. This case illustrates an emergence of dysfunction in gait in a pt with otherwise improved function and reinforces the need for an interdisciplinary approach to the care of these pts. Reportable event: one month after implant the pt had moderate to severe bradykinesia, rest tremor and rigidity, postural instability and gait worsening with falls. Eight months later after 6 months of extensive physical therapy his gait and balance significantly improved; he was able to walk without a ambulatory aid.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161219
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dennis100
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« Reply #11 on: January 16, 2014, 12:26:57 AM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient experienced a shocking or jolting sensation down her arm when she reached for something. There was no known incident or accident related to the complaint. The patient had a few falls 'quite some time' before the shocking symptoms appeared. The patient status was reported as 'fair' at the time of the complaint. The patient was seen twice by her hcp since the initial complaint; details of the visits were not available at the time of this report. Additional information has been requested. A follow-up report will be submitted if additional information becomes available. Please see mfr. Report # 3004209178-2008-05453.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1150401
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dennis100
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« Reply #12 on: January 16, 2014, 05:03:32 AM »

Model Number 7428
Device Problem Device remains implanted
Event Date 10/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the patient experienced a loss of efficacy. The patient did not feel the loss of the efficacy was due to the stimulation therapy, although they have had a few falls in the past week and felt the lack of effect may have been the cause of some of the falls. The patient was considering going to the emergency room if they were unable to get in contact with the hcp. No further symptoms or outcome were reported. 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=1225565
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dennis100
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« Reply #13 on: January 16, 2014, 05:04:38 AM »

Model Number 7426
Device Problem Pocket stimulation
Event Date 09/01/2008
Event Type  Malfunction 
Event Description
The pt did not experience a reduction in symptoms following deep brain stimulator implant. She fell about once a day. Her left toes used to be relaxed and began curling a month ago. Following a fall, the pt felt a prickling sensation in the device pocket when she was sitting. A follow-up appointment with the hcp had been set. Add'l info has been requested. A follow-up report will be submitted if add'l info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1231240
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dennis100
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« Reply #14 on: January 16, 2014, 06:22:55 AM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 07/01/2008
Event Type  Malfunction 
Event Description
The patient fell several times; the most recent fall was a month ago. Afterward, he experienced a 'deadening of the legs'. The deep brain stimulator was still working. No device troubleshooting was reported. Additional information has been requested. A follow-up report will be submitted if additional information becomes available. Please see mfr. Report# 30420917200807653.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1277789
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« Reply #15 on: January 16, 2014, 06:23:58 AM »

Model Number 7428
Device Problem Device remains implanted
Event Date 08/01/2008
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that since the pt's stimulator was replaced, the pt has not had any therapeutic effect. The pt experienced recent falls, including one serious enough to result in a broken hip. The relationship of the falls to the lack of therapeutic effect was not reported. At the time of the report the pt was in a rehabilitation facility, and the pt's status was reported as fair. Add'l info has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1248101
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dennis100
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« Reply #16 on: January 16, 2014, 06:25:14 AM »

Model Number 7426
Device Problems High impedance; Lead(s), breakage of
Event Date 10/01/2008
Event Type  Malfunction 
Event Description
It was reported the pt was experiencing a loss of therapeutic effect starting about three weeks prior. Impedances were tested and were >2000 ohms on all of the unipolar pairs. There was no recent fall or trauma. Additional information received indicated the pt had reported falling back, but had not had any falls since then. The pt had reported feeling a "popping" type pain in her neck approximately one month ago. X-rays were taken of the lead/extension connection. A fracture in the lead was observed. The pt was referred to a neurosurgeon and was scheduled for a lead revision in 2008. At the time of this report, pt outcome and revision status were unk.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1249852
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dennis100
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« Reply #17 on: January 17, 2014, 08:17:42 AM »

Model Number 7426
Device Problem Implant, reprogramming of
Event Date 12/01/2008
Event Type  Injury 
Manufacturer Narrative
See scanned page.

 
Event Description
It was reported the pt lost simulation sensation. The loss of efficacy occurred following a fall. The pt condition worsened over the course of the week. The pt had multiple falls during the week. It was also reported the pt had an infection. The site of the infection and device relationship was unk at the time of the report. The pt had been in to see their physician in the last week. Additional info received indicated sometimes in 2008, it was noted, following a fall, the pt had some drainage at the old incision site. Neurosurgery evaluated the wound and antibiotics and betadine dressing changes were ordered. Since that time the incision has been doing fine. The device was reprogrammed in early december and no further changes have been needed. The hcp stated the patient falls were unrelated to the device system. The pt had balance issues and falls prior to the device being implanted due to her diagnosis of pd (parkinson's disease). See mfr report #3004209178-2009-00548.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1296868
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dennis100
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« Reply #18 on: January 17, 2014, 08:18:24 AM »

Model Number 7428
Device Problem Device remains implanted
Event Date 12/01/2008
Event Type  Injury 
Event Description
It was reported the patient had pain on the left side of his body near his armpit. The stimulator is implanted on the left side. The patient turned the stimulation down but it did not help with the pain. The pain "felt like a heart attack". This type of pain has occurred in the past on the right side. The pain on the right side was controlled when the physician lowered the settings. The patient needs the stimulation higher to control his symptoms. The patient falls about every week. The patient was seen by a physician but not the physician who monitors his device, the physician ran a few tests. The test results were not provided. The patient was at home at the time of the report. The patient was directed to contact his physician to check the device system. 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=1291941
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« Reply #19 on: January 17, 2014, 12:06:05 PM »

Model Number 7426
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 11/01/2008
Event Type  Injury  
Manufacturer Narrative
 
Event Description
It was reported the pt experienced a lack of effect, shuffling gait and shoulder pain after a fall two weeks ago. The pt had add'l falls since the event. It was also reported the pt had a possible torn rotator cuff. The left shoulder felt pulling, left side of the face felt pulling, and pain in her left eye for the last two days. The pt was unable to adjust the stimulation. When the status lights were assessed, both batteries appeared good (lights on). The pain in the shoulder was described as acute pain. The ambulation difficulties included increased shuffling of her feet. The left part of the pt's face felt numb. It was also reported the pt had chest pains and an asthma attack while driving home the day before. The pt went to the er for the symptoms. An x-ray of the pt's shoulder was done. An ekg was performed. The physician had turned the device off to perform the ekg reading. A magnet was used to turn the device off, and back on following the ekg. The pt had reported a lessening of symptoms but the physician was unsure if the device was on. The pt was unable to ascertain if the left ipg felt better on or off. The pt's numbness and pulling on the left side of the face and pain over the eye, was reportedly worse when the device was on. The er physician planned to turn the left ipg off and leave it off until the pt could see their following physician. Add'l info has been requested. See also mfr report # 3004209178-2009-00057.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1280549
« Last Edit: January 17, 2014, 12:36:49 PM by dennis100 » Logged
dennis100
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« Reply #20 on: January 17, 2014, 12:36:24 PM »

Model Number 7426
Device Problem Device remains implanted
Event Date 01/01/2008
Event Type  Injury 
Manufacturer Narrative
 
Event Description
It was reported the patient had difficulty walking, leg weakness and paresthesias. The patient complained that after her most recent programming session her speech became like a whispering and she had fallen nine times. The patient was directed to contact to physician for a reprogramming consultation. Additional information has been requested from the hcp, but was not available as of the date of this report. Refer to manufacturer report # 3004209178200900227.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1287241
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« Reply #21 on: January 17, 2014, 12:37:59 PM »

Model Number 7428
Device Problem Low impedance
Event Date 12/01/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
The patient experienced a loss of therapeutic effect. He fell to his hand and knees. Other details of the fall were not known. Lead 1 was set to amplitude 1. 8 volts, pulse width 90 microseconds, rate 190 hertz, unipolar therapy, impedance of 83 ohms. Lead 2 was set to amplitude 2. 5 volts, pulse width 90 microseconds, rate 190 hertz, unipolar therapy, impedance of 964 ohms. The hcp reported a unipolar impedance of 83 ohms, measured at 1. 8 volts. The battery was at 2. 44 volts. 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=1308393
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« Reply #22 on: January 17, 2014, 12:40:04 PM »

Model Number 7426
Device Problems Inappropriate shock; Implant, reprogramming of
Event Date 05/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that beginning in 2007, the pt experienced a range of "surges" from "mild to one that goes though me that makes me lurch/jump a little bit". The shocking was "not so bad" but as the pt began to keep track, he noticed the shocking/jolting "happening a dozen times a day". The pt had periodic shocks and feelings of electricity in the chest and down the left arm 'emanating from a wire". When the pt used the programmer to check the battery, he "felt a surge of electricity go through me". After experiencing a powerful jolt, the pt feels lightheaded for 10-20 seconds. The pt reported an increase in tremors in the right hand and shaking worse than prior to the implant. The pt stated he had, "reasonable handwriting and now barely able to sign my own name - big scribble". The pt had an appointment with the hcp, although the hcp felt there was no issue with the shocking and, the tremors were a progression of the disease. The pt additionally reported falling and fracturing his right hip, but did not feel it was due to the device, as he was having issues prior to the fall. Impedance readings were done with all monopolar readings within normal limits. Bipolar readings between 0 and 3 were >2000 ohms. X-rays showed no sign of a lead fracture. The battery was found to be at 3. 57 volts. The device was reprogrammed around the 0 contact. The pt had changed his hcp and was scheduled to replacement surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1286581
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« Reply #23 on: January 17, 2014, 07:26:48 PM »

Model Number 7426
Device Problems Intermittent continuity; Unit inactivated; Suspect EMI
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
See also manufacturer report 3004209178200900789. It was reported that the pt was falling much more since her device replacement though her tremor was still controlled. She was falling approximately 4-5 times per week and experienced intermittent stimulation. The device turned off when the pt walked by a refrigerator or microwave, and when she drove under a power line. No injury was reported. Further info is being requested from hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1371378
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« Reply #24 on: January 17, 2014, 07:27:21 PM »

Model Number 7426
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 12/01/2008
Event Type  Injury 
Manufacturer Narrative
 
Event Description
It was reported the patient was not able to adjust their stimulation. The ipg light was off. The last time the patient saw the light on was approximately two weeks ago. The patient experienced a loss of therapeutic effect and return of pd symptoms. The patient's symptoms were described by the patients spouse as "falls an awful lot, excessively" and has "some dyskinesia but not too much tremor and is not super stiff. " the patient also was experiencing "involuntary eye closure", which the patient's spouse believed was the cause of him "bumping into everything. " the patient reportedly had a bad fall about 2 weeks ago, where he "fell flat on his forehead" and had a "nosebleed and bump. " the patient was seeking a new physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1307991
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« Reply #25 on: January 17, 2014, 10:57:31 PM »

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

 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1395022
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« Reply #26 on: January 17, 2014, 10:58:47 PM »

Model Number 7426
Device Problems High impedance; Replace
Event Date 07/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
The device was returned to the manufacturer. Final device analysis results revealed - the battery had broken welds at the bond wire pads (lifted bond wires). The case feedthrough wire was lifted from the hybrid bond pad. The epoxy bond was broken between the hybrid circuit and both battery terminals. There was foreign material in the connector ports. The insulation coating and titanium can was scratched. The ipg battery voltage was 3. 68 volts. Good stable output was observed on electrodes 0-3. No output was observed when the ipg was in unipolar mode. The primary finding was - broken welds at the bond wire pads (lifted bond wires).

 
Event Description
It was reported the patient fell about six weeks ago. About 10 days prior to the report, the patient experienced a loss of therapeutic effect. The patient was seen in the clinic. There was impedance readings >2000 ohms on some or all bipolar pairs (pairs were not specified). The patient status was reported as good. The healthcare provider was considering further troubleshooting. Additional information was requested. Additional information received indicated the device was replaced due to normal battery depletion. The patient recovered without sequela. Reference mfr report # 3004209178200806167.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1366220
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« Reply #27 on: January 18, 2014, 06:07:39 AM »

Device Problems Device remains implanted; Inappropriate shock
Event Date 01/01/2009
Event Type  Malfunction 
Event Description
It was reported that patient experienced a loss of therapeutic effect. The patient felt "electrocuted" by the system. It was reported that the patient also experienced a return of disease, falling, tremors, and the inability to get out of bed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1428933
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« Reply #28 on: January 18, 2014, 06:08:52 AM »

Model Number 7428
Device Problem High impedance
Event Date 03/18/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
At the initial programming session, impedance readings were >4000 ohms on some of the bipolar pairs and 1395 ohms with <15 ma (microamps) for all the other bipolar pairs. All electrodes and case were 1161 ohms and 39 ma. All bipolar pairs were 2354 ohms and 19 ma. Additional programming and testing was recommended. On (b) (6) 2009, it was reported that reprogramming had resolved the issue and the patient received good efficacy. On (b) (6) 2009 it was reported that the patient had good therapy for a week and then lost stimulation. There was no accident or incident related to the event. The patient did fall after it stopped working. Therapy impedances were >4000 ohms. It was recommended that the default test values be increased and the test re-run. The testing was redone at 3. 5 volts; the results were not reported. Reprogramming was recommended. Additional information has been requested, a follow-up report will be sent if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1428944
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« Reply #29 on: January 18, 2014, 06:40:23 AM »

Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
The pt fell with increased frequency, at least once a week. The latest fall was on the pt's left shoulder. The pt had right-sided dyskinesia. The pt was seen in clinic. The left-sided device had a therapy impedance of greater than 2000 ohms. Bipolar electrode impedances were greater than 2000 ohms with low current on all pairs except the case-2 combination. The right-sided device had impedances greater than 2000 ohms on combination 0-1, 0-2, 0-3, and 1-3.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1372427
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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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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.

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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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« 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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« 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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« 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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« 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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« 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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« Reply #60 on: April 10, 2014, 08:09:18 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Concomitant medical products: product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 3387s-40, lot# v499735, implanted: (b)(6) 2010, product type: lead. Product id: 3387s-40, lot# v460686, implanted: (b)(6) 2010, product type: lead. (b)(4).

 
Event Description
It was reported that the patient had 10 ultra sound treatments beforehand and 2 weeks ago had 6 procedures. It was noted that the patient had a loss of therapeutic effect. It was noted that the reporter stated that with all the patient¿s medications the patient lost their balance all the time and fell frequently. It was noted that when the patient fell they did not hit their head and fell on their elbow and broke it. It was noted that the patient also had experienced changes in mental cognitive abilities. It was noted that again it was worse. It was noted that the patient had uncontrollable movements, and made spontaneous drastic movements, with their hands and sometimes hit the wall for furniture. It was noted that the patient had gone to the health care professional (hcp) and was referred for physical therapy. It was noted that the hcp was checking the device. Additional information received reported that the patient recently had an ultrasound and was not feeling well. It was noted that the ultrasound was five days ago and the patient had a convulsion like epilepsy and was shaking. It was noted that the patient had an ultrasound because of the parkinson¿s. It was noted that the patient had hit their elbow and the elbow had a bump so the patient was referred for ultrasound. It was noted that it was therapeutic ultra sound. It was noted that patient had had this before when the weather was changing and was thinking it was maybe the ultrasound procedure. Additional information has been requested, but it was not available as of the date of this report.

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« Reply #61 on: April 10, 2014, 08:10:17 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient had more tremors in the last 2 weeks and had a tendency to fall, sometimes 2-3 times a day with some of them noted as ¿quite heavy. ¿ in addition, it was reported the patient could not connect with the implantable neurostimulator (ins) using the programmer unit. This issue was resolved when the antenna accessory was unplugged from the programmer (although it was noted that the connection also worked with the antenna plugged into the programmer). Follow up information received from the healthcare professional (hcp) on (b)(6) 2013 reported that cause of the event was likely urinary tract infection (uti), severe parkinson¿s disease, and sub optimal placement of the lead components of the ins system. If additional information is received, a follow up report will be sent.

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« Reply #62 on: April 10, 2014, 08:10:54 AM »

Model Number 37612
Event Type  Injury   Patient Outcome  Disability
Event Description
It was reported that while stimulation was turned on the patient¿s equilibrium was off and he had been falling forward and to the left for the past 6 months prior to the date of this report. It was noted that the patient saw the healthcare professional every 6 months and the healthcare professional had mentioned that it was a possible side effects from surgery. It was further noted that the patient had looked up possible equilibrium after deep brain stimulator surgery and it stated it was possible. When the implantable neurostimulator (ins) was off the patient was not feeling his equilibrium off but the shaking started back. It was noted that because of the patient¿s condition he was getting a wheelchair. Additional information was requested but had not been received as of the date of this report.

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« Reply #63 on: May 11, 2014, 10:14:15 PM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).
Event Description
It was reported the patient¿s deep brain stimulation (dbs) device was implanted (b)(6) of 2012 and they could never program it. The leads were implanted and ten days later they put the battery pack in and they waited another ten days before they turned it on to program it. The patient¿s healthcare provider (hcp) could not figure out why on the lowest setting the patient could not talk, his left arm would come up to his chest when he would walk and his right shoulder kept twitching or spasming. From the time it was implanted the device did not really function for the patient; every time they turned it on and gave him medications to try to control the dyskinesia it did not work and this was after a year of oral medication. It was noted the patient was dyskinetic the entire time the device was implanted. It stayed in for about a year until they could not figure out why or what was going on. Every time the patient turned it on ¿patient shoulder would, he was falling three times a day. ¿ the patient fell in his house and broke his ribs the last saturday in (b)(6) 2012. The patient¿s dbs device was turned off and he was better but he still had some of the dyskinesia and had tremendous headaches. In (b)(6) of 2013, the patient had his device removed as he could not handle it anymore. The patient was sure there was a short circuit or something like that which caused the dyskinesia. It was reported the patient thought the leads down in the globus thalamus would not do that, he understood it may affect his speech, but not the rest of it. It was reported the device was leading to such headaches and such problems; he had a big bony growth behind his ear in his skull which was occurring during the entire time the device was implanted. After the device was removed those symptoms went away. Additional information received two weeks later reported somewhere around the second week of (b)(6) 2012 the patient was in severe dyskinesia one night and he could not turn it off. He did not know what was going on and he finally got in touch with a manufacturer representative from (b)(4) who walked his wife through turning his device off. It was also reported the patient¿s unit did not come out easily, the leads and all that stuff did not come out easily. 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.

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« Reply #64 on: July 04, 2014, 10:45:29 PM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Product id 7426, serial# (b)(4), implanted: 2007 (b)(6), explanted: 2013 (b)(6); product type implantable neurostimulator product id 7426, serial# (b)(4), implanted: 2007 (b)(6); product type implantable neurostimulator product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 3387-40, lot# j0211551v, implanted: 2002 (b)(6); product type lead product id 3387-40, lot# j0214131v, implanted: 2002 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 7438; product type programmer, patient product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 3387-40, lot# j0211551v, implanted: 2002 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 3387-40, lot# j0211551v, implanted: 2002 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2002 (b)(6); product type extension product id 3387-40, lot# j0214131v, implanted: 2002 (b)(6); product type lead. (b)(4).
Event Description
It was later reported that the patient was not doing well. The patient was ¿doing the same falling. ¿ patient loses her balance, crosses her feet and her legs freeze causing her to fall. It was noted that this had been going on for ten years prior to the date of this report. The patient would fall 2 or 3 times a day. It was noted that as a result of the falls the patient had had to have knee replacements and knee cap surgery. The patient had a walker but if she had to grab or anything she fell. It was noted that when the first implant was put in 2002 it had helped with her walking. The battery was replaced in 2007 and it ¿did good¿ for about a week and then the patient all of a sudden started having trouble walking. In 2013, one of the batteries was replaced but the other had shown no wear and it was unknown how or why. The device did help with the patient¿s tremors. The patient did not know if she wanted the lead fixed because, she had been in the hospital for 2 weeks and spent 3 months in a nursing home recovering. It was noted that the right battery was the one that was replaced in 2013 and the left was the one that had shown no use, left battery was like brand new. Reference manufacturer¿s report number: 3004209178-2012-10670.

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« Reply #65 on: July 04, 2014, 11:56:04 PM »

Model Number 7426
Event Type Injury Patient Outcome Other
Event Description
It was reported the patient was getting ¿zapped¿ in their head at the time of report. It was stated it had been going on for 2 years prior to report. It was noted a few weeks prior the patient started to have seizures more often and they thought the device might have contributed to that. It was stated the patient fell more often and they were losing strength in their legs.
Manufacturer Narrative
Product id: 3387-40, lot# j0104141v, implanted: (b)(6) 2001, product type: lead. Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 2001, product type: extension. (b)(4).

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« Reply #66 on: August 10, 2014, 06:14:25 AM »

Model Number 37601
Event Date 05/15/2014
Event Type Injury Patient Outcome Other
Event Description
It was originally reported on (b)(6) 2014 that the patient fell on the day of the report and hit her back on the edge of a table. The area was really tender and the patient was going to go to urgent care and wanted to check if she could have an x-ray. The patient noted that it was not due to her device or therapy, but due to her parkinson¿s. The patient had a tendency to fall every once in a while without knowing she was going to. About two and a half weeks later it was reported that the patient still had concerns regarding her device or therapy but was working with her doctor or manufacturer representative. The patient listed an appointment for (b)(6) 2014. About three weeks later it was reported that the patient had an increased number of falls since implant. The patient noted that she was falling even before implant, but the falls tended to be more controlled and ¿softer. ¿ the patient stated that before she would ¿just get bruises¿ and was now falling twice as much. The patient thought it may be even in the wake of turning on the implantable neurostimulator (ins) a month after implant. The patient had a fall at easter time. The patient then had a fall on (b)(6) 2014 and two in the ¿last week. ¿ one when the patient was coming in the door, stubbed her foot, and fell and hit her rib. The patient was diagnosed with a cracked rib. The patient then fell again on (b)(6) 2014 and fractured vertebrae l1 by ct analysis at an emergency room (er). At the time of the report the patient fell flat on her behind while standing in the kitchen. The patient was uncertain if she was bending over and noted her dog was there, so she really was unsure how that fall happened. The patient had been on pain medication since the fall and went out and did some yard work the day prior and that seemed to aggravate things. The cause of the event seemed to be temporally related to the surgery. It was a brand new battery, no depletion, and no issues with the lead or extension. It may be worse since turning on the ins and programming, so the patient was asked to turn off the ins and come in for reprogramming on (b)(6) 2014. The patient was also asked to use adaptive equipment to prevent falls, specifically a cane or walker. The patient had an injury and was in recovery, non-life-threatening, but clearly at risk for more falling and there was concern regarding her balance and gait and potential for future falls and injury.

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« Reply #67 on: August 11, 2014, 01:27:59 AM »

Model Number 37602
Event Date 07/09/2014
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported, the patient had fallen two days prior to report and chipped their tooth and they may lose one of their front teeth because of the fall. It was noted they had been put back on antibiotics to prevent an infection from forming in the patient¿s mouth. They had been off of antibiotics from the possible urine infection for 2-3 weeks before they were put on the antibiotics again for their mouth. The patient had a number of falls ¿lately. ¿ it was noted they had a near fall the day prior to report and a major fall 2 days prior. The patient started to take falls during the summer time. It was noted, the issues with the dbs batteries did contribute to the falls.

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« Reply #68 on: September 06, 2014, 01:48:36 AM »

Model Number 37603
Event Type Injury Patient Outcome Other
Event Description
It was reported that the patient had had balance issues and trouble with speech since implant. It was noted that the patient had fallen a couple of times. Initially it was thought that the patient¿s medication was off but he had been off the medication and was still having problems. Patient had been instructed to turn stimulation down and had further programming appointment scheduled for the friday following the date of this report. Patient¿s stimulation was down from 3. 30 and 4. 10 to 3. 0 and 3. 40. Patient¿s status was unknown. It was later reported that there was disappointment and dissatisfaction expressed about the therapy as far as what had been sold and presented to them prior to implant and what had happened in reality. Patient had tremors prior to the deep brain stimulator implant. Patient had been pretested and it had worked for him. Almost 2 months after implant the patient had a lot of issues. Patient¿s quality of life had not increased. Patient had an appointment scheduled for (b)(6) 2014. Patient was experiencing symptoms. It was noted that the patient had expected it to be an outpatient surgery and instead patient had spent 10 days in rehab. The patient had been told about the risk of infection and stroke but nothing else. The patient had been trained on using the patient programmer but did not know what to do with it. The patient was not very discouraged and not positive. The patient was not enjoying things in life anymore. It was noted that prior to deep brain stimulator surgery the patient had only had some tremors and had not been that advanced with parkinson¿s disease symptoms. The deep brain stimulator surgery was supposed to make the patient better but had made him worse. Patient was not able to return to his physical job. Patient¿s symptoms were change in gait, lethargy, and seizures. It was further noted that the manufacturing representative had been there when the patient had a seizure and the representative had come to rehab. The patient had had a seizure right after surgery at the hospital on the date of implant. At rehab the patient had been completely out of it and had been unresponsive. The healthcare professionals were blaming it on medications. Patient was put on 4 different seizure medications, one being dilantin. Patient no longer took seizure medication. Patient was unresponsive and was sent for a computerized tomography scan (cat scan) which had determined the patient had seizures and that was when patient was put on seizure medications. The healthcare professionals had stated ¿oh no, he should be responsive. ¿ it was noted that nobody seemed to know what was going on. They had come for physical therapy and were not able to wake him up, he had been completely out of it. An electroencephalogram (eeg) was done and had not found anything particular. Following deep brain stimulator surgery patient had the following symptoms: speech issues, gait issues, balance problems, patient had fallen several times, extremely tired, swallowing issues, patient looked at food as if he did not know how to put a fork into it, and patient looked like he had aged (b)(6). Patient used to work full time, go to ymca 3 times a week and drove a car, patient was no longer able to drive or do anything. It was hard to leave the patient alone. It was believed that symptoms were device related because patient had no chemicals in his body except some medication for parkinson¿s and it was not a lot. Healthcare professionals stated they had never seen those symptoms after a deep brain stimulator surgery. Patient was told that this kind of reaction was very common and it might take 6 months to a year to recover from the surgery. Patient had been given a limit on the patient programmer and could not go beyond ¿4 or something. ¿ patient had been adjusting therapy all the time on his own. Patient got better here and there but still had a lot of issues going on and was no longer positive. Patient was scheduled to see the healthcare professional on friday following the date of this report. Additional information received reported the patient was having some gait and speech issues related to programming. Patient had primary tremor with parkinson¿s and as the patient would get tremor control he would get some speech issues. The patient had since been reprogrammed to a bipolar setting and although he had a little bit of a breakthrough tremor his balance was better and so was his speech the last time the manufacturing representative had spoken to the patient. It was unknown if there were any other updates. The manufacturing representative had been involved with the patient through rehab. It was noted that the patient¿s family was anxious about getting the patient¿s progress and getting him programmed so he could go back to work. As of the week prior to the date of this report the patient was doing better and was planning on returning to work. Additional information received reported the alleged seizure was not the reason for rehab and all of their patient¿s go through a rehab cycle. Seizure was not confirmed and had been discussed after the fact. The patient was having some cognitive issues after the battery placement that had led the healthcare professional to believe it may have been a seizure. Patient had been placed on seizure medication and had not had any seizure activity after the first alleged one. Additional information was requested but had not been received as of the date of this report.
Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3389s-40, lot# va0jcu8, implanted: (b)(6) 2014, product type: lead. (b)(4).

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« Reply #69 on: September 06, 2014, 05:04:24 AM »

Model Number 37603
Event Type Injury Patient Outcome Other
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3387s-40, lot# va0arp9, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0bbqp, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).
Event Description
It was reported that the patient¿s hands had started to clasp together during the night since (b)(6) 2013. After that, three months after implant, the patient began falling a lot. The patient fell once or twice a day and in (b)(6) 2014 he broke his leg. The patient had not fallen since that time. The patient had lost a lot of coordination and stumbled when he walked. The patient would hold on to something when he walked to keep himself more stable. This issue had been happening for ¿a while,¿ but the patient could not provide an exact date, and he thought his coordination could be getting worse. The healthcare provider (hcp) thought the cause of the event was gait ataxia or possible orthostatic hypotension with polyneuropathy. The therapy was still working for the patient¿s tremors. The patient had an appointment scheduled with his implant surgeon for (b)(6) 2014. Medical intervention and the patient outcome were not reported, so additional information was requested. If additional information is received, a supplemental report will be sent. Refer to manufacturing report #3004209178-2014-15622 as the patient had two ins¿s and it was not specified which was the issue.

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« Reply #70 on: September 06, 2014, 06:20:22 AM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, lo# unknown, serial# unknown, implanted: (b)(6) 2010, product type: lead. 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: neu_ptm_prog, serial# unknown, product type: programmer, patient. (b)(4).
Event Description
It was reported that the patient had needed an implantable neurostimulator (ins) change out the second week of (b)(6) prior to the date of this report. During the week of (b)(6) 2014, the patient had started having therapy issues which had involved more freezing episodes and falling frequently. The patient had fallen once weekly during that time. It was noted that since the ins change out those problems had been less of an issue. The healthcare professional ran impedances on the system and had told the patient that they were normal. The patient had inquired if loss of efficacy was normal toward end of service (eos). Patient¿s therapy was better but not completely back to where it was before the therapy issues had begun. Additional information was requested but had not been received as of the date of this report.

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« Reply #71 on: October 12, 2014, 03:17:48 AM »

Model Number 37601
Event Date 08/06/2014
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient had ¿not been able to have effective stimulation since the implant¿ and that ¿she was worse off with her symptoms¿ following the replacement of her previously depleted implantable neurostimulator (ins). The patient had met with her physician and was told ¿it was the implanted battery that was not working¿ and that ¿they were not able to adjust stimulation. ¿ despite this, it was noted the physician had ¿cranked the stimulation up from 3. 9 to 4. 8 (volts)¿ with ¿no change¿ in the patient¿s symptoms. The patient was ¿unable to get up on her own, she was constantly freezing due to the condition, her head was falling to the side and freezes until she is assisted¿ and she had ¿lost weight¿ and had ¿no appetite¿ at the time of report. The patient ¿could not walk by herself¿ either at that time. It was reported the patient experienced ¿lethargy, loss of reflexes, paralysis, and less than 50% therapy relief¿ that was associated with the event. Information regarding interventions and the patient¿s outcome was not available. Additional information has been requested. A supplemental report will be filed if additional information is received.

Manufacturer Narrative
(b)(4).

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« Reply #72 on: October 12, 2014, 06:10:22 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient had been falling for the past 3 months prior to the date of this report. The patient had taken some pretty hard falls and had been falling about 2-3-5 times a week. The patient had been losing her balance. The patient wanted to know if everything was ok with therapy. The last time the patient was in the healthcare professionals office was in (b)(6) prior to the date of this report and nothing was wrong when checked. There was a patient injury. Following the patient¿s worst fall she had spent 6 weeks in rehab for a cracked pelvic bone. The patient had fell two days prior to the date of this report and hit her head in the bathroom and had gotten a black eye which looked awful. The patient had had more than that and had hit her shoulder. The patient had a speech therapist she was working with and thought she was better that way for speech. The patient had lost the controller since (b)(6) prior to the date of this report. The patient had an appointment with her healthcare professional scheduled in (b)(6). 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 products: product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2013, product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v436025, implanted: (b)(6) 2010, product type lead; product id 3389s-40, lot # v411494, implanted: (b)(6) 2010, product type lead. (b)(4).

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« Reply #73 on: October 12, 2014, 12:34:57 PM »

Model Number 37601
Event Type Injury
Event Description
It was reported that there was a loss of therapeutic effect. Patient was implanted with the deep brain stimulator about 3 years prior to the date of this report. The patient was quickly going back to shaking like prior to implant. The patient had been falling, dropping things and shaking lightly which had started about 3-4 months prior to the date of this report. It was noted that it had gradually gotten worse and worse and then the patient had started falling. On friday prior to the date of this report, the patient had fallen twice and he could not get up and was unable to get inside which was the worst he had fallen. The patient hurt his back and he had laid there for 3 hours. Since sometime towards to the end of (b)(6), the patient¿s shaking had gotten a little worse and he was unable to hold a glass in his left hand. It was noted that it appeared he would have a new implant sometime in (b)(6), as they were trying to get him in for surgery because ¿this thing was getting worse and worse. ¿ the patient had never turned his stimulation off before. The patient was unable to adjust stimulation after his granddaughter got a hold of his programmer and turned his stimulation down to 0 volts on 1 side, and he was now unable to turn it back up again. When the patient would try and increase stimulation, he would get an information screen but was unable to describe the exact picture on the screen. During the phone call the patient ended up adjusting something and was now able to increase the stimulation and was at 5. 3 volts on the left side and 4. 10 volts on the right, and the issue was resolved. 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
Product id 37085-60, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 37085-60, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 3387s-40, lot# v833497, implanted: 2011 (b)(6); product type lead product id 3387s-40, lot# v779188, implanted: 2011 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient. (b)(4).

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« Reply #74 on: October 13, 2014, 12:31:23 AM »

Model Number 37603
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387s-40, lot# va01d5k, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708640, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3387s-40, lot # va01ngu, implanted: (b)(6) 2012, product type lead; product id 37085-40, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 37642, serial # (b)(4), product type programmer, patient. (b)(4).

Event Description
It was reported the patient had fallen and broke their shoulder on (b)(6) 2014 and had surgery the following day. They had therapy for about 3 weeks and things were progressing. They thought their symptoms after surgery were worse than before but the last 2 or 3 days prior to report their symptoms had gotten much worse. They had worked with a physical therapist at home on the day of report and could barely walk across the room. They had more shaking getting started from a dead stop. There was a patient injury and a loss of therapeutic effect. It was noted the patient programmer batteries were dead and they had never used the programmer in two years. The patient changed the batteries and performed a check on the right side first. They saw a doctor and phone screen. After, they performed a check on the left side and they saw ¿on and ok¿ for the left side. The patient outcome was not provided. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be submitted.

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« Reply #75 on: October 13, 2014, 02:03:08 AM »

Model Number 7426
Event Type Injury
Event Description
It was reported that there was a loss of therapeutic effect. It was noted that the patient was new to the healthcare provider (hcp) and the first time they saw this patient was the day of the report and didn¿t have any medical history on the patient. The patient had been falling, up to 20 times a day. The patient may have many falls during a day or none at all. The patient had a gradual change in benefit over the past year. The right implantable neurostimulator (ins) was dead. The left ins was at 3. 71volts but there was concern about the therapy impedance on the left ins. There was concern about lower therapy impedance of 486ohms with a current of 57. The patient was programmed to 1- 2-c+, 3. 3 volts, rate of 60 microseconds, frequency of 130 hertz, with 24 hours, 7 days a week use. The longevity was 47 months. Electrode impedances measured were in normal range. The patient symptoms were the same on both sides at the time of the report, even though one ins was dead and the left side of the body symptoms may have been a little bit worse than the right side. The hcp didn¿t think the patient was getting much benefit from the ins that was on. No x-rays were taken and no programming was tried yet. The patient was last seen in (b)(6) 2014 by another hcp, but the ins was not checked at that time. The ins status was rechecked, and was ¿showing ok and at 3. 71volts and ok. ¿ electrode impedances were done again and were very similar to the values seen earlier, and the therapy impedance was 488 ohms, current of 57. The ins was on coming into the session, total hours used was 9283 hours. This had been a gradual change for the patient over the past year. The patient had falls in the past and has hit his head. It was noted that the hcp would do an ins replacement. It was later noted that the hcp programed the patient to 3. 6 volts on the left ins and the patient had a little improvement in finger dexterity. There were no concerns about the end of service (eos) or ins longevity on the ins that was dead. It was determined that the cause of the event was device related. The right ins was not explanted or replaced at the time of the report. It was unknown how the patient was doing. They were awaiting a neurosurgery appointment to replace the ins, at the time of the report, but it was unclear which ins was going to be replaced. Information regarding patient outcome and status on device explant has been requested which was not reported regarding this event. If additional information is received, a follow-up report will be sent. Please refer to manufacturer report # 3004209178-2014-16728. It was unclear which ins was being replaced.

Manufacturer Narrative
Concomitant products: product id 7426, serial # (b)(6), implanted: (b)(6) 2011, product type implantable neurostimulator; product id 3387-40, lot # j0527324v, implanted: (b)(6) 2006, product type lead; product id 748251, serial # (b)(6), implanted: (b)(6) 2006, product type extension; product id neu_unknown_ext, lot # unknown, product type extension; product id neu_unknown_lead, lot # unknown, product type lead. (b)(4).

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« Reply #76 on: October 13, 2014, 03:19:05 AM »

Model Number 37602
Event Type Malfunction
Event Description
It was reported that one of the patient¿s falls that had occurred about a year prior to the date of this report had most likely caused a short in the lead in the patient¿s brain. The healthcare professional did not think that the patient was a good candidate for surgery as the patient took plavax which was a blood thinner. The patient took this due to a heart attack that the patient had had 2 years prior to the date of this report. The patient had already had a battery replacement once but it had only lasted 3 months and the rechargeable system was recommended to the patient. Reference manufacturer¿s report number: 3004209178-2014-00651.

Manufacturer Narrative
Concomitant products: product id 37602, serial # (b)(6), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type implantable neurostimulator; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3387s-40, lot # v499735, implanted: (b)(6) 2010, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 3387s-40, lot # v020086, implanted: (b)(6) 2007, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37602, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type implantable neurostimulator. (b)(4).

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« Reply #77 on: November 07, 2014, 10:58:06 PM »

Model Number 7426
Event Type Injury
Event Description
It was reported that the patient was seen last in (b)(6) 2013 and they would be seen by their clinician 2 days following report. The electrode impedances were measured and they were all fine and normal. The ins that was implanted on their right chest had a slight tingling sensation to their arm. Additional information received reported the patient still had concerns with their device or therapy, but they were working with their manufacturer representative or doctor. It was stated they had an appointment scheduled for (b)(6) 2014. Additional information received reported there was a 50% or greater symptom reduction. It was later reported that the patient was scheduled to have both of the implantable neurostimulators (inss) replaced on (b)(6) 2014. The patient was seen on (b)(6) 2014 for adjustment and reprogramming. The right stimulator was interrogated and the patient had mild paresthesia in the left arm. Right side settings were at 4. 1v, 90usec, 185hz, and 3+2- with minimal tremor in the left arm. The patient was seen on (b)(6) 2014 and there was no evidence of discontinuity of the leads of extensions. The patient¿s was also seen on (b)(6) 2014 for a device adjustment, weakness and gait difficulty. The weakness onset had been gradual and occurring in a persistent pattern for 4 months prior to the appointment, but had first occurred more than 40 years of age. Weakness had been characterized as difficulty arising from a chair, climbing stairs, walking, and increased weakness following exertion and at the end of the day. Weakness was located in the legs and on the right side only. It was associated with numbness. Patient had falls, difficulty ambulating and a gait disturbance. Onset for gait issues had been gradual starting about 8 months prior to the appointment, but was worsening. The patient had slow speech, romberg sign positive, impaired toes, and was tandem walking impaired which were noted during a physical exam. The patient was still experiencing frequent shocks with the battery with fluctuating responses of the battery. The patient was going to be scheduled for a neurosurgery appointment for a battery change. For numbness and tingling, low back pain and right leg weakness an electromyography (emg) and computerized tomography (ct) were going to be performed. Reference manufacturer¿s report number: 3004209178-2014-12463 for the patient¿s other implanted system and the shocking issues that were isolated to that system.

Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 3387s-40, lot# v368056, implanted: (b)(6) 2009, product type: lead. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210587
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« Reply #78 on: November 08, 2014, 03:31:13 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient¿s programmer was making increases in voltage too quickly and not working appropriately. The patient¿s wife reported that he was having difficulties for a couple of weeks, but thought it was user error. The wife tried it on the day of the report and found that when she made an adjustment it moved to the maximum setting instead of by 0. 1. The nurse practitioner (np) was working with the wife and it seemed as though she was using the programmer appropriately. The np stated that the right lead was the issue and it jumped from 1. 6 volts to 2. 2 volts when trying to increase by 0. 1 volt. This jumping had caused the patient to fall several times and he felt a heavy jolt. The wife stated that the ¿stimulation was spiking, and they made sure that it was not user error on their part, and once she was decreasing the setting, his one setting spiked from 0. 7 to 2. 2 which sent him into a convulsion when this spike occurred and they could not figure out why it was occurring, but it dropped him to the floor about five minutes ago, but it had been going on for a couple of weeks. ¿ the wife stated that this only happened when making adjustments with the programmer and she did not think any of the buttons were stuck down. The wife noted ¿it was the setting on the other side that was spiking, the right side remained consistent. ¿ upon return of the patient programmer analysis found the antenna jack broken. The top case assembly was scratched and the bottom case assembly was damaged. C300. The patient outcome was not reported or if a new programmer resolved the issue, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant products: product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # va02y9y, implanted: (b)(6) 2012, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4166830
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« Reply #79 on: January 10, 2015, 11:26:45 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported the patient had been falling. They fell and broke their collar bone and had lacerations on his head. The patient had fallen 13 times since april. It was stated they had one fall in rehab after implant and then started to have more falls after rehab. Impedances were noted as fine. They had turned the deep brain stimulator (dbs) off to see if the patient continued to fall. 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. Please see manufacturer report #3004209178-2014-22314 for information on the patient's concomitant system.

Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3387s-40, lot# va0ery5, 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. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4287020
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« Reply #80 on: February 07, 2015, 06:45:23 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3389s-40, lot# v091844, implanted: (b)(6) 2008, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 3389s-40, lot# v032588, implanted: (b)(6) 2008, product type: lead product id: 7438, serial# (b)(4), implanted: (b)(6) 2008, product type: programmer, patient. (b)(4).

Event Description
It was reported that the patient had been admitted to the hospital for frequent falls. It had started on sunday prior to the date of this report and the patient had fallen three times on that day. The patient¿s behaviors were not like they used to be, the patient was hallucinating, agitated and combative. They wanted a manufacturing representative to come assess the implantable neurostimulator (ins). The patient had parkinson¿s disease. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4434518
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« Reply #81 on: February 07, 2015, 06:46:01 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3387-40, lot# j0421698v, 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# j0421511v, implanted: (b)(6) 2004, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37752, serial# (b)(4), product type: recharger. (b)(4).

Event Description
It was reported that there was a shocking or jolting sensation. The patient¿s device had gotten disconnected when he had fallen and he would get a buzz or shock in his chest when he would adjust it. It was unknown when the fall was because he had fallen several times. It had been sometime in-between the implant and his replacement surgery. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4409062
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« Reply #82 on: February 07, 2015, 09:14:21 AM »

Model Number 37601
Event Type Malfunction
Event Description
It was reported that the patient had the device implanted on (b)(6) 2014 for parkinson¿s and the patient believed the right side was disconnected. The patient had a return of tremors on the left side, he could not walk and kept falling. It was noted that when the patient was taking a shower he had rubbed his head kind of hard and scratched it a little and when he pressed down on his head he could feel tingling in his feet and legs on the left side. This had all begun 3-4 days prior to the date of this report. The patient had called and scheduled an appointment for (b)(6) 2014. 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.

Manufacturer Narrative
Concomitant medical products: product id 3389s-40, lot# va0d7cw, implanted: (b)(6) 2014, product type: lead; product id 3389s-40, lot# va0fgjj, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4). (b)(6).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4388049
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« Reply #83 on: February 07, 2015, 11:19:58 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that the device had worked wonderful for the patient¿s upper extremities, but they had dystonia in their left foot that caused their foot to be at almost a 90 degree angle. It had helped with all other symptoms besides the patient¿s foot. This made it impossible for the patient to walk and they kept falling. The patient had this problem before implant. The patient¿s healthcare provider (hcp) instructed them to turn the device off. The hcp thought they could help fix the issues, but wanted the patient to turn stimulation off for a week to week and a half, so they could start over. The patient later reported that he turned stimulation off, but program c was still on. About a month later the patient still had concerns regarding his device or therapy, but was working with their hcp or a manufacturer representative. The patient had an appointment on (b)(6) 2014. The patient knew what a, b, and c were, but wanted to know what they control. The patient wrote that a felt like it was in their legs, b in their voice and they were stuttering, and they did not know what c did. The patient stated they used all three. Six months later the patient reported the patient programmer screen showed the ¿check the implantable neurostimulator (ins)¿ screen. There was a problem with the programmer and the programmer worked intermittently. When the patient checked the ins they got the stimulation turned off screen. The patient tried to turn stimulation back on, but they could not make a connection. The patient saw stimulation off and a flashing triangle with the battery on the top row of the programmer and 3. 108 below that. Usually the patient could feel a small voltage going through their body when they move to program b or c, but they did not feel anything at the time of this report. The patient¿s wife stated that it had been worrying the patient a good bit because they had to use the ins more than ever. The patient had symptoms of slurred speech. The patient had turned the ins off for a short period of time and they have never had any trouble with it so they assumed it was the batteries. The reporter stated the patient was beginning to get it a little on the right side. The patient had dystonia real bad and ¿afib¿ that caused them to fall almost every day. When the patient¿s hcp ¿hooked up the final wires¿ the patient was walking again, but their left foot was turning in. The reporter stated the hcp told them that normally the patients get better and they had never seen one get so bad. The patient¿s right foot turned towards the middle and they had a brace on it. The patient did use a walker to walk. The patient¿s foot started turning in about three weeks after surgery. For the past six months the patient was starting to get dizzy when they stood up and tried to take a step. The patient had fallen once close to thanksgiving and then again about six weeks prior to this report. After the first fall the patient had a concussion and after the second fall the patient was taken by ambulance to the hospital because they thought their hip may be broken. The patient had been to the orthopedic hcp twice since then. 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 37642, serial# (b)(4), product type: programmer, patient; product id 3 387s-40, lot# va09grv, implanted: (b)(6) 2013, product type: lead; product id 748351, serial# (b)(4), implanted: (b)(6) 2013, 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=4386252
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« Reply #84 on: March 07, 2015, 04:40:39 AM »

Model Number 7426
Event Type Injury
Event Description
It was reported the patient had been having a lot of problems with falling and they were in a wheelchair. A patient injury was reported. The reporter stated they thought the patient fell 37 times before they had surgery for their back in (b)(6) 2010. The patient continued to fall since the surgery in 2010. The reporter stated they read something about deep brain stimulation and heard there was a recall that covered a lead so they wondered if the patient¿s implantable neurostimulator (ins) that was removed was part of the recall. The patient¿s ins was replaced on (b)(4) 2014. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, the event will be updated.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v165128, implanted: (b)(4) 2008, product type: lead. Product id: 7482a40, serial# (b)(4), product type: extension. Product id: 3387s-40, lot# v165128, implanted: (b)(6) 2008, product type: lead. Product id: neu_unknown_prog, product type: programmer, physician. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4484557
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« Reply #85 on: April 19, 2015, 01:22:11 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported the patient had a total of 3 surgeries for the deep brain stimulator (dbs) system. They had done well with the first two surgeries but the third surgery ¿totally did him in. ¿ he had lost muscle strength, had seizures, big falls, and towards the end of his life when he was in the hospital he could not control moving his right foot. The patient was told they had parkinson¿s disease but originally the patient was not diagnosed with that and he just had essential tremors pre-dbs surgeries. No further follow-up is being done on this event as the patient died and it was stated to be unrelated to the device or therapy. The death occurred following the event and therefore, unable to follow-up for patient outcome. Please see manufacturer report #3004209178-2015-04324 for information on the patient's concomitant system.

Manufacturer Narrative
Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator; product id 3387s-40, lot# v556377, implanted: (b)(6) 2011, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension; product id 3387s-40, lot# v603771, implanted: (b)(6) 2011, product type: lead; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4577570
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« Reply #86 on: April 19, 2015, 01:23:07 AM »

Model Number 37603
Event Date 01/08/2015
Event Type Injury
Manufacturer Narrative
Product id 3387s-40, lot# va0nfax, implanted: 2014 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension. (b)(4).

Event Description
It was reported, the patient had developed a large left subdural hematoma with 6 mm midline shift to the right. Observation and repeated scans were done as an intervention. A ct scan without contrast showed large left convexity mixed age subdural hematoma effacing left hemispheric sulci and resulting in 6 mm midline shift to the right. The patient was scanned again in (b)(6) and showed a chronic left subdural hematoma that had continued mixed density suggesting there had been further hemorrhage. The volume of the subdural hematoma was slightly larger and the left to right shift measured 7 mm. The patient was scanned again a few days later and showed the mixed density subdural hematoma collection was not significantly changed. The patient underwent an elective burr hole evacuation a couple days after the last ct scan. The evacuation did not resolve the subdural hematoma. The patient also began to have weakness with falls after the subdural hematoma was first noted. The evacuation date was moved up due to the falls. The event required medical or surgical intervention and resulted in in-patient hospitalization and prolonged existing hospitalization. The etiology was the lead/extension tract and was unlikely related to the device or therapy and possibly related to the implant procedure. The event was ongoing with no further action needed. 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=4638254
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« Reply #87 on: May 09, 2015, 02:04:45 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that the patient had started going downhill in (b)(6) 2014. The patient had started falling a lot in (b)(6) 2014 which was why the patient had to be put into a nursing home on (b)(6) 2015. It was noted that after one of the patient¿s falls onto the floor the patient was placed in a hospital but it was unknown when the patient was admitted or when the fall was. The patient was released from the hospital on (b)(6) 2015 and was then admitted to the nursing care facility. The patient had fallen through the shower door, by the shower and a couple of times by the bed. The healthcare professional had done x-rays and everything was fine. The patient had very low blood pressure and took medication to bring the blood pressure up. It was noted that there were also times where he got up right away and he should not be doing that. The patient was in a wheelchair and does not walk with his walker. Starting in (b)(6) 2014 the patient had also been having trouble swallowing anything. The patient coughed a lot when he ate and even when he drank water. One day the patient had coughed really badly for a quite a while. The patient¿s wife pureed the food for patient and added thickening for liquids. On (b)(6) 2015 they had done a swallowing/aspiration test and it was pretty bad. The patient might get a g-tube for feeding purposes. The patient¿s last battery had lasted from 2005 to 2011 and they thought this battery would last for 5 years. The patient¿s family thought the battery was getting low because the patient was having neurological and swallowing issues which were symptoms that the patient usually had when their battery was getting low. The family wanted the implantable neurostimulator (ins) checked before placing the g-tube. The healthcare professional was unsure if the patient was getting benefit from the deep brain stimulator. 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. Reference manufacturer¿s report number: 3004209178-2015-07114.

Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator. Product id: 3389s-40, lot# v010293, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 748295, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4684090
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« Reply #88 on: May 09, 2015, 02:05:31 AM »

Model Number 7426
Event Date 09/15/2013
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that there was an increase of frequency of falls. The increase of falls occurred after the adjustment of stimulation parameters. The adjustment included a decrease of frequency and augmentation of voltage. The patient experienced hospitalization or prolongation of existing hospitalization. The event was possible or certainly related to the stimulation and medication. The event resolved completely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4717965
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« Reply #89 on: June 08, 2015, 05:55:37 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported the patient had surgery last (b)(6) and ¿it had not worked since the implant. ¿ it was noted the patient would ¿pick up speed when they would talk. ¿ it was stated since the surgery the patient had fallen down 6-7 times. It was noted the patient had speech impairment and it was hard to understand them. It was later reported that there was a poor communication screen but they were eventually able to conform with both the left and right sides on and ok. Stimulation was turned off and back on. Since implant the patient had been falling down and losing her balance much more than before the implant. The patient¿s balance and falls had gotten worse after implant and the patient was unsure if it was safe to walk and she used a walker. The patient had had a major fall about 2 months after implant,(b)(6) or (b)(6), she had fallen on the carpet while she was hanging clothes. It was noted that the patient went to rehab after the fall. Patient wanted to discuss turning therapy off to see if it would improve her falls/balance. Patient inquired about lead placement and how it effects stimulation. The patient was not sure if the deep brain stimulator was causing her falls but felt that it was either the deep brain stimulator or disease progression. It was later reported that since implant the patient had balance issues. The patient had never had this before implant and had fallen multiple times. The patient was told that it was due to her recent surgery. The patient was still falling and had broken her hand from a fall. Reference manufacturer¿s report number: 3004209178-2015-08800.

Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3387s-40, lot# va01zjk, implanted: (b)(6) 2012, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4) implanted: (b)(6) 2012, product type: extension. Product id: 3387s-40, lot# va01zjk, implanted: (b)(6) 2012, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id 37603 lot# serial#(b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4761849
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« Reply #90 on: August 08, 2015, 08:24:09 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v333260, implanted: (b)(6) 2009, product type lead; product id 3389s-40, lot # v276341, implanted: (b)(6) 2009, product type lead; 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; product id 37642, serial # (b)(4), product type programmer, patient. (b)(4).

Event Description
It was reported there was a loss of therapeutic effect. The patient was falling. He used to fall before having the implantable neurostimulator (ins) but now he was starting to fall again. They fell 2-3 times two days prior to report and went to the er at midnight. The patient fell again several times the day prior to report and went to the er again at 10pm. While the patient was in the er they had a ct scan on the head. The ct scan that was done in the emergency room was negative. He also fell several times while on vacation for 2 months in (b)(6) 2015. The patient was trying to walk and he had been freezing in his legs. They had told him to move his legs and he couldn¿t. It was noted that this was something the patient had previously to the ins. The falls had been getting worse and because of the falls, he had torn his left shoulder out of the pocket and he has to get his left shoulder fixed. His legs were deteriorating and he doesn¿t have strength in his legs. Additional information received 3 days later reported there was not a 50% or greater symptom reduction. The cause of the event was not determined and it was unknown if it was device related. It was unknown if reprogramming was needed. The patient wondered if a ¿wire came loose with falls. ¿ the patient was going to be hospitalized on (b)(6) 2015 and they would check for wire fracture. They would have an upcoming admission to the hospital for medication adjustment. The patient had not yet recovered and they were in physical therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4898863
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« Reply #91 on: September 07, 2015, 06:45:41 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
(b)(4). Analysis of the neurostimulator, serial #(b)(4), found no anomaly. The ins was received with the ¿dose¿ option enabled for 30 minutes. The ¿dose¿ option enabled the stimulation output to be turned on, and then output shut off after the specified amount of time. The returned ins output was monitored while stimulation was on. After 30 minutes, the output would shut off. With the ¿dose¿ option enabled, the returned ins was functioning as programmed.

Event Description
The healthcare provider (hcp) and patient reported via the manufacturer representative (rep) that there was concern about the left implantable neurostimulator (ins) battery's condition. After checking the ins in the hospital with the rep, hcp, and patient all together, it was found that the problem was that the ins continuously turned off after 30 minutes. The patient reportedly continuously complained of this to the hcp two years after implant. However, the hcp did not notice why it was happening and thought it was affected by electromagnetic interference (emi) due to electronics. The patient mentioned there were some side effects after two years as she was falling down continuously on the right side. It was later reported that the issue began one year after implant; it was thus unclear if it began one or two years after implant. There was no troubleshooting done on the left ins as it was not easy to check out the problem due to 30 minute gaps after it turned on. The ins was eventually replaced. The patient's health was good and the condition of her health was better than before. However, she still fell down to the right side, so her condition would be continuously checked. The patient's indications for use were unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5038464
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« Reply #92 on: September 07, 2015, 06:46:34 AM »

Model Number 7428
Event Type Injury
Event Description
The patient's health care provider (hcp) reported via the company representative (rep) that fracture of the radius occurred after downfall with activated stimulation. It was unknown what led to this event. It was unknown if diagnostics/troubleshooting was performed. It was unknown what interventions/actions were taken. The device remained implanted and in service. The issue was resolved at the time of this report. The hcp has no further information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5017573
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dennis100
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« Reply #93 on: September 07, 2015, 06:47:34 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 37601, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator. Product id 3387-40, lot# j0322214v, implanted: (b)(6) 2003, product type: lead. Product id 748266, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id 37642, serial# (b)(4), product type: programmer, patient. Product id 3387-40, lot# j0327188v, implanted: (b)(6) 2003, product type: lead. Product id 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id 64002, lot# n274415, implanted: (b)(6) 2011, product type: adapter. Product id 37092, lot# 276480001, implanted: (b)(6) 2011, product type: accessory. (b)(4).

Event Description
The consumer reported that over the past five years the patient had experienced sudden "bouts" of dementia and that each time they experienced these symptoms they had been given antibiotics, which seemed to take care of the symptoms. The last time this happened, however, the antibiotics did not take care of the patient's symptoms, and the patient's family was wondering if the symptoms could be a result of an undetected infection with one of the components. It was noted that the patient fell a lot and did not seem to have impulse control, which is when they would have a fall. No outcome or diagnostics were provided. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent. Indications for use: parkinsons dual movement disorders refer to manufacturer report # 3004209178-2015-16415.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5019305
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dennis100
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« Reply #94 on: September 07, 2015, 06:48:27 AM »

Model Number 37601
Event Type Injury
Event Description
A consumer reported the patient was hospitalized on (b)(6) 2015. A week before the hospitalization the patient was falling and getting weak. The patient had a bowel infection called "c diff. " at the time of this report, the patient was home and the infection was getting better, but the patient's mental state was not. The patient was non-responsive. Physical therapy came to the patient's home, sat them up, and asked them to move their leg, but they were non-responsive. The implantable neurostimulator (ins) was checked and it seemed fine. The patient's indication for use is parkinson's dual and movement disorders. 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 products: product id 3389s-40, lot # v091127, implanted: (b)(6) 2008, product type lead; product id 3389s-40, lot # v091127, implanted: (b)(6) 2008, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a5,1 serial # (b)(4), implanted: (b)(6) 2008, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2008, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5021303
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