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Author Topic: Deep brain stimulator - Falls  (Read 37809 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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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