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Author Topic: Deep brain stimulator - Walking/Gait  (Read 84407 times)
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dennis100
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« Reply #30 on: January 03, 2014, 07:20:17 PM »

Model Number 7428
Device Problems Intermittent continuity; Explanted
Event Date 07/07/2006
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The neurostimulator was returned after 44 months because generator underwent a power on reset, which caused the patient to be completely immobile. The device was replaced and returned to the manufacturer for analysis.

 
Manufacturer Narrative
Preliminary analysis results were not available on the date of this report. A follow up report will be sent when final analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=814307
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dennis100
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« Reply #31 on: January 03, 2014, 07:21:39 PM »

Model Number LEAD
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
The patient reported that following dbs system placement; symptoms of tremor were adequately controlled, but the patient's ability to walk suddenly deteriorated. The representative re-directed the patient to report symptoms to her physician and to follow-up with the hcp regarding the patient therapy controller. Additional information has been requested. A follow-up report will be sent if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=832543
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dennis100
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« Reply #32 on: January 04, 2014, 03:28:47 AM »

Model Number 3387
Device Problem Device remains implanted
Event Date 09/01/2007
Event Type  Injury   Patient Outcome  Other
Event Description
The patient reported a loss therapeutic effect; they had experienced symptoms of speech problems and "a fast tippy-toe walk" and indicated their current condition was fair. The patient was redirected to report symptoms to the hcp and for medical evaluation. Additional information has been requested from the physician. Refer to mfr report #6000153-2007-04672.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=971388
« Last Edit: January 04, 2014, 03:31:59 AM by dennis100 » Logged
Birdbomb
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« Reply #33 on: January 04, 2014, 09:12:50 AM »

Wish I knew if the inability to walk on these people, was a temporary thing  or not.  Boy, what a frightening side effect.
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"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
dennis100
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« Reply #34 on: January 04, 2014, 01:07:13 PM »

Deep brain stimulation is nothing but a barbaric medical procedure that is putting a steady flow of money into the pockets of the surgeons & neurologists (at our expense). Just like vagus nerve stimulation, does more harm than good.

All those responsible for the approval of those devices should be sent to the slammer!
« Last Edit: January 28, 2014, 05:19:35 AM by dennis100 » Logged
dennis100
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« Reply #35 on: January 05, 2014, 02:34:39 PM »

Model Number 3389
Device Problem Implant, repositioning of
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Journal reference: tommasi, et al. Freezing and hypokinesia of gait induced by stimulation of the subthalamic region. Journal of neurological sciences, 2007, 258-99-103. A patient being treated for advanced parkinson disease with bilateral deep stimulation (dbs) experienced a gait disturbance (freezing and hypokinesia) related to the stimulation of a misplaced left sided dbs electrode. Repositioning/replacement of the left side electrode resulted in complete relief of the gait disturbance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=961723
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dennis100
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« Reply #36 on: January 05, 2014, 02:36:29 PM »

Device Problems High impedance; Device remains implanted; Implant, reprogramming of
Event Date 11/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The hcp reported high impedance. The pt is receiving some efficacy, but has some freezing and afternoon/evening gate issues. The pt's medications have been reduced by 25 percent. The mfr rep interrogated the device and reported impedances >4000 ohms at 1. 4 volts, on all or some of the unipolar pairs. The rep repeated the impedance test at 2 volts and impedances remained high on electrodes 0 and 1. The rep reported the pt experiences a funny feeling in her head and has some motor responses at higher amplitudes, so the rep is unable to conduct an impedance check at higher amplitudes. The pt has only had the device implanted for 1 month and currently receives therapy benefit using electrode 2. The pt has some dyskinesia with the neurostimulator off, but the dyskinesia goes away when the neurostimulator is on. The system appears intact for programming; evidenced by the pt's positive response to therapy. Refer to medwatch report #2182207-2007-04414.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=964217
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dennis100
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« Reply #37 on: January 05, 2014, 02:38:00 PM »

Model Number 3387
Device Problems Explanted; Replace; Implant, reprogramming of
Event Date 07/01/2005
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt's husband reported the deep brain stimulator electrodes were placed in 2004. Two weeks after implant, the pt's condition worsened. The pt experienced ambulation difficulties and needed a walker or a wheelchair to get around. The hcp reported the pt experienced parkinsonian dyskinesia including freezing, unsteady gait and leaning forward while walking. The pt complained of legs collapsing beneath them. The pt was reprogrammed several times. The pt's voltage was increased from 1 volt to 3. 5 volts. The hcp reported the pt experienced severe dystonic leg pain. The pt's medications were adjusted. X-ray, ct and mri scans revealed no abnormalities. The pt was referred to another physician. The pt was reprogrammed again. The device voltage was reduced from 3. 5 to 2. 0 volts. In 2006, the left lead and extension were removed and the right lead was repositioned. The left lead and extension were replaced in 2007. The pt is doing well and walking again. Refer to medwatch # 6000153200702669.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=900147
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dennis100
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« Reply #38 on: January 05, 2014, 03:57:01 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
The patient's wife reported the device was working well for the patient and he was walking without a cane. Then, a couple of times when the md would read the patient's device the patient would get a shock/jolt and his eyes would roll back in his head. She stated that the hcp would turn the device off and it took a while for the patient's arms to come back to his side. She reported that now the patient's mouth moves constantly and he can barely walk. Additional information has been requested from the hcp, but was not available as of the date of this report. A follow-up report will be sent if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=898206
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dennis100
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« Reply #39 on: January 06, 2014, 09:22:24 PM »

Model Number 3387 OR 3389
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Journal reference: kupsch, et al. "pallidal deep-brain stimulation in primary generalized or segmental dystonia. " new england journal of medicine; 2006; 355: p. 1978 - 1990. Forty patients with primary segmental or generalized dystonia received implanted deep brain stimulation and were randomly assigned to receive either neurostimulation or sham stimulation for 3 months. The comparative results were reported on. Reported event: one patient experienced a gait disorder during the extension phase of the study. The symptoms were generally improved or resolved with changes in stimulation parameters.

 
Manufacturer Narrative
No medwatch form was received from the user facility; therefore, info on the medwatch form 3500a was completed by medtronic with info from the article. "any missing or incomplete data on form 3500a are the result of info not being provided by the reporter. ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=949264
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dennis100
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« Reply #40 on: January 06, 2014, 09:23:58 PM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each pt, the devices used and the complications experienced was not provided. It is possible that each pt may have experienced more than one complication. [see scanned pages].

 
Event Description
Journal reference: guehl, et al. "side-effects of subthalamic stimulation in parkinson's disease: clinical evolution and predictive factors" european journal of neurology; 2006; 13; 9 p. 963-971. The article presents study results describing the evolution of side effects in a cohort of patients at 3 and 12 months. The patients, all with advanced parkinsons disease, were being treated with bilateral deep brain stimulation of the stn. A number of pt complications were reported. Reportable event(s): there were reports of freezing with occasional falls. One pt reported the symptoms at 3 months and 3 reported symptoms at 12 months. Treatment and outcome info was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=949477
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dennis100
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« Reply #41 on: January 06, 2014, 09:25:01 PM »

Model Number 3389
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each patient, the devices used and the complications experienced was not provided. It is possible that each patient may have experienced more than one complication. No medwatch form was received from the user facility; therefore, information on the medwatch form 3500a was completed by medtronic with information from the article. See scanned pages.

 
Event Description
Journal reference: deuschl et al. "a randomized trial of deep-brain stimulation for parkinson's disease" the new england journal of medicine; 2006; 355; 9; p. 896-908. The article describes the results of a randomized-pair trial of patients with advanced parkinson's disease and severe motor symptoms. The study compared neurostimulation (deep brain stimulation) with medication only. A number of neurostimulation patient complications were reported. Reportable event(s): seven patients experienced severe worsening of mobility (4 mild, 1 moderate, 2 severe) requiring outpatient treatment. Treatment and outcome information was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=949284
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dennis100
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« Reply #42 on: January 08, 2014, 05:29:37 PM »

Model Number 7428
Device Problems Device remains implanted; Implant, reprogramming of
Event Date 05/12/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient's home care physical therapist reported the patient's motor coordination and gait have decreased dramatically since implant. Additional information was requested from the patient's physician. The physician reported increased gait disturbance. A ct scan of the head was negative. Physical and occupational evaluations were conducted, along with multiple programming adjustments. No patient improvement with the device off. The patient is depressed and rehabilitation is ongoing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=881389
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dennis100
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« Reply #43 on: January 08, 2014, 05:30:17 PM »

Model Number 3389
Device Problems Device remains implanted; Implant, reprogramming of; Suspect EMI
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient reported following system reprogramming in 2005, his left foot would turn in, which made his knee hurt and he turned the right-side stimulator off. In 2006, the right-side stimulator was reprogrammed and turned on. One week later, his left arm and shoulder were stiff, his balance was poor and it was difficult to walk; the toes on his left foot curled. He reported his left shoulder and arm were worse with the stimulator off; he couldn't extend the arm over his head, it pulled up his side. The pt indicated he worked near high voltage and installed dc motors and rfid equipment readers, which may have damaged the dbs device and caused false readings. The following month, he was reprogrammed because problems with his left arm/shoulder and balance made work difficult. After reprogramming one month later, the pt reported no improvement in his symptoms. Approx four months later, the company representative suspected electrode migration at follow-up. His physician said the symptoms were due to disease progression; an implanting surgeon indicated the pt would not benefit from lead repositioning. The pt indicated after re-programming in 2007, the toes on his left foot curled up, he had slurred speech and poor balance. The company representative directed the pt to continue to report symptoms to his hcp. Additional info has been requested from the physician.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=884743
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dennis100
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« Reply #44 on: January 08, 2014, 06:08:50 PM »

Model Number LEADMVD
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 08/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The hcp reported the patient has experienced a recent loss of efficacy; the patient is unable to walk. Therapy and bipolar measurements obtained were within range; battery measurements were as expected. The rep redirected the hcp to review patient symptoms with the physician; imaging was recommended if lack of efficacy continues.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=918355
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dennis100
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« Reply #45 on: January 08, 2014, 06:09:26 PM »


Model Number 3389
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each patient, the devices used and the complications experienced was not provided. It is possible that each patient may have experienced more than one complication. No medwatch form was received from the user facility; therefore, information on the medwatch form 3500a was completed by medtronic with information from the article. See scanned pages.

 
Event Description
Journal reference: deuschl et al. "a randomized trial of deep-brain stimulation for parkinson's disease" the new england journal of medicine; 2006; 355; 9; p. 896-908. The article describes the results of a randomized-pair trial of patients with advanced parkinson's disease and severe motor symptoms. The study compared neurostimulation (deep brain stimulation) with medication only. A number of neurostimulation patient complications were reported. Reportable event(s): some patients experienced worsening of mobility requiring admission to hospital. Treatment and outcome information was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=949285
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dennis100
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« Reply #46 on: January 08, 2014, 06:10:05 PM »

Model Number 7426
Device Problems Device remains implanted; Implant, reprogramming of
Event Date 10/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient's friend reported the patient has never had good therapy, except for a brief time post-implant. The patient has new symptoms since implant that plague the patient daily (except while reclining): weakness, stiff neck, can't walk, head "feels" swollen and over-all malaise. The patient has been reprogrammed several times at the doctor's office. Device interrogation did not reveal any problems, however, lead placement was never checked. Surgery is not scheduled. Additional information has been requested by medtronic from the health care professional regarding the reported event. A supplemental mdr follow-up report will be sent to fda if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=943156
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dennis100
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« Reply #47 on: January 09, 2014, 09:15:27 AM »

Model Number 7426
Device Problems Device remains implanted; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 01/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
It was reported the pt experienced difficulty walking after going through the airport while traveling. The pt did not have the hand-held programmer with him. The pt did not know if the device was on or off. The mfr reviewed the basic functionality of using a magnet to turn the device on or off. The pt was instructed to contact their hcp. Additional info has ben requested by medtronic from the health care professional regarding the reported event. A supplemental mdr follow-up report will be sent to the fda if additional info is received. Refer to medwatch report # 3004209178-2008-00720.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1001684
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dennis100
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« Reply #48 on: January 09, 2014, 09:16:19 AM »

Model Number 3387
Device Problems Device remains implanted; Unit inactivated; Implant, reprogramming of
Event Date 01/01/2005
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt reported, since implant in 2004, they have not had good therapeutic effect. The pt was implanted with a dbs system to treat essential tremor in their right hand. In 2005, the pt reported tingling in the tongue and arm. Reprogramming occurred once or twice but it was unclear if there was any effect. In eleven months later, the pt was feeling tingling in the hands and toes and then in 2006, the pt reported they became unable to walk. The pt indicated she was taking medications but did not provide any further info. The pt reported following several programming sessions in 2006, she turned the stimulator off. With the stimulator off, the pt reported the tingling is "very bad" and "very painful" and that she is using a wheelchair and can't walk. The pt reported mri scans had been performed but nothing was found to be the cause of her symptoms. Additional info has been requested from the pt's hcp but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=996516
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dennis100
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« Reply #49 on: January 09, 2014, 09:17:32 AM »

Model Number 3387
Device Problem Device remains activated
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: murata et al. "deep brain stimulation of the posterior subthalamic area (zi. Raprl) for intractable tremor. " no shinkei geka 2007; 35(4): 355-362. Eight cases with severe essential tremor and 18 of tremor-dominant parkinson disease were treated with unilateral dbs of the area including the zona incerta and the prelemniscal radiation (zi/raprl). Tremors have been well controlled for 24 months with almost stable stimulation parameters, and no obvious adverse effects of stimulation. Reportable event: in some patients in whom the electrode was placed in a lateral approach, or in whom needed high voltage because of severe tremor, spasticity of the lower limbs was sometime seen during walking. Exact number of patients affected is not listed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=989160
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dennis100
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« Reply #50 on: January 09, 2014, 09:18:33 AM »

Model Number 3387
Device Problem Device remains activated
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: ostrem, et al. "pallidal deep brain stimulation in patients with cranial-cervical dystonia (meige syndrome). " movement disorders: 2007;22(13): 1885-1891. This article reports on a study of the effect of bilateral pallidal deep brain stimulation (dbs) in a series of patients (6 males, 1 female) with pharmacoresistant idiopathic cranial-cervical dystonia (iccd). Data for 1 patient (female) were excluded from the analysis because the post-op mri showed the left dbs lead not positioned at the intended target; the lead was later repositioned. Therefore, n=6. Patients were implanted with bilateral leads, quadripolar dbs (model 3387, medtronic); dual channel pulse generator (medtronic kinetra); 40-cm lead extenders. The mean age of patients at surgery was 66. 2 years (range, 52-70), and the mean duration of disease onset was 8. 2 years (range, 2-20). Four of 6 patients reported new difficulty with coordination and slowness in motor functions that had been normal and free of dystonia preoperatively: worsening of handwriting, typing, balance, and walking. Described as mild and not evidence on objective clinical exam, the deficits disappeared when the stimulator was turned off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=991650
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dennis100
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« Reply #51 on: January 09, 2014, 09:19:34 AM »

Model Number 3387
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Event Description
Gait changes in response to subthalamic nucleus stimulation in people with parkinson disease. A case series report. J neurol phys ther. 2006; 30(4): 184-194. The article describes the results from a case series that involved patients being treated with deep drain stimulation (dbs) of the subthalamic nucleus for management of advanced parkinson disease. The goal of the study was to evaluate the effects of unilateral and bilateral stimulation on gait following staged stimulator implants. Three pts experienced worsening gait following bilateral stimulation. A male pt (2) experienced an increase in falls and freezing in the medication on state post bilateral stimulation. Unilateral stimulation produced a gait velocity decrease. No treatment or outcome info was provided.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=982849
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dennis100
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« Reply #52 on: January 09, 2014, 09:20:19 AM »

Model Number 3387
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: kelly ve, samii a, slimp jc, price r, goodkin r, shumway-cook a. Gait changes in response to subthalamic nucleus stimulation in people with parkinson disease: a case series report. J neurol phys ther. 2006; 30(4): 184-194. The article describes the results from a case series that involved 6 pts being treated with deep drain stimulation (dbs) of the subthalamic nucleus for management of advanced parkinson disease. The goal of the study was to evaluate the effects of unilateral and bilateral stimulation on gait following staged stimulator implants. Three pts experienced worsening gait following bilateral stimulation. A female pt (3) experienced a post surgery (unilateral and bilateral) slightly worsening of mobility (walking difficult). Gait velocity decreased with bilateral stimulation. Treatment and outcome info was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=982850
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dennis100
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« Reply #53 on: January 09, 2014, 09:21:09 AM »

Model Number 3387
Device Problem Device, or device fragments remain in patient
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: kelly ve, samii a, slimp jc, price r, goodkin r, shumway-cook a. Gait changes in response to subthalamic nucleus stimulation in people with parkinson disease: a case series report. J neurol phys ther. 2006; 30(4): 184-194. The article describes the results from a case series that involved 6 patients being treated with deep brain stimulation (dbs) of the subthalamic nucleus for management of advanced parkinson disease. The goal of the study was to evaluate the effects of unilateral and bilateral stimulation on gait following staged stimulator implants. Three patients experienced worsening gait following bilateral stimulation. A male patient experienced worsening of his gait following unilateral stimulation and difficulty walking following bilateral stimulation. The patient deactivated one of the stimulators when walking.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=982610
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dennis100
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« Reply #54 on: January 09, 2014, 09:21:58 AM »

Model Number 3389
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 08/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient's wife reported that the reprogramming had left her husband (the patient) unable to walk or talk since implant. She further reported that the patient's lead placement was good and she believed that the poor therapy was entirely related to the programming. She included that the patient's new hcp stated that he did not understand the settings the programmer used and could see why the patient had inadequate therapy. Additional information has been requested, a follow-up report will be submitted if additional information becomes available. See manufacturer's report# 6000153200800239.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=979879
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« Reply #55 on: January 09, 2014, 02:07:59 PM »

Model Number 3387
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
Event Description
Journal reference: zesiewicz ta, sullivan kl, hoffman m, et al. Delayed thalamic intracranial hemorrhage in essential tremor pt following deep brain stimulation. Eur neurol 2008;59(3-4):187-189. We report the case of a man with et and a history of controlled hypertension who developed a delayed thalamic intracerebral hemorrhage (ich) almost 9 weeks following dbs surgery. Reportable event: the day after his nine week eval, which was normal, the pt woke up from an afternoon nap with right-sided arm and leg weakness, slurred speech, and a right facial droop. Neurologically, the pt was lethargic, oriented to his name and disoriented to place and time. Cranial nerve examination was significant for a right facial paresis. Motor examination demonstrated right upper and lower extremity weakness. Sensory examination demonstrated right hemi-hypoesthesia, and the pt had an extensor plantar reflex on the right. Ct and mri of the brain without contrast showed a left-sided thalamic ich adjoining the distal portion of the deep brain stimulator electrode. His dsb unit was turned off. His blood pressures remained stable, and he improved clinically having normal mmse, mild dysarthria, mild right facial weakness, and right upper and lower extremity weakness in the ensuing 6 weeks. He was able to ambulate with the use of a walker.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053631
« Last Edit: January 09, 2014, 02:09:54 PM by dennis100 » Logged
dennis100
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« Reply #56 on: January 09, 2014, 02:09:07 PM »

Model Number 3389
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: granziera c, pollo c, russman h, et al. Sub-acute delayed failure of subthalamic dbs in parkinson's disease: the role of micro-lesion effect. Parkinsonism relat disord 2008; 14(2):109-113. We reviewed a cohort of 56 pd pts that underwent bilateral stereotactic stn implantation and we studied a subset of five pts that, after early clinical improvement, developed a rapidly progressive neurological deterioration unresponsive to dbs. Pts presenting delayed failure (df) did not differ from the rest of the cohort by any of the pre-operative characteristics; therefore, the presence of this micro-lesioning effect might be considered as warning sign for pts that need a careful follow-up. Reportable event: some pts developed, at df time, a degree of bradykinesia, and gait disorders that negatively influenced their dependency in activities of daily living. Some presented gait ignition failure, some had difficulties for turning around and bypassing obstacles, some pts suffered from festination and freezing while walking.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053617
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dennis100
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« Reply #57 on: January 09, 2014, 05:29:11 PM »

Model Number 3389
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: blomstedt p, hariz mi, lees a, et al. Acute severe depression induced by intraoperative stimulation of the substantia nigra: a case report. Parkinsonism relat disord 2008; 14(3): 253-256. We present a man with parkinson's disease (pd) who underwent bilateral stimulation in the subthalamic nucleus (stn). During the intraoperative evaluation, stimulation through the lowest contact in the right stn area, induced an acute depressive state, during which the pt was crying and expressing that he did not want to live. The pt returned to his normal state of mood within seconds after the cessation of stimulation. Repeated blinded stimulations resulted in the same response immediate postoperative magnetic resonance imaging (mri) revealed that the lowest contact of the right electrode was located in the substantia nigra. Reportable event: the pt has now been followed for 5 years. During this period, no changes in mood have been noted, nor any other psychological or cognitive change. The main recent complaints have been gait and balance difficulties, freezing of gait and stuttering (freezing of speech) when on medication and on stimulation.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1057804
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dennis100
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« Reply #58 on: January 09, 2014, 05:29:42 PM »

Model Number 7426
Device Problems Battery failure; Replace
Event Date 08/01/2006
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
It was reported that the pt experienced ambulation difficulties, return of tremor, and had difficulties completing activities of daily living. An x-ray was performed (2006), no fractures were detected in the deep brain stimulation system. There was also no response from the left neurostimulator (ins) when telemetry was attempted. The pt's left ins and extension were replaced. The pt regained therapeutic benefit. The pt recovered without sequela.

 
Manufacturer Narrative
The serial number is included in the range for the medtronic kinentra/soletra lifted bond wire recall (2007). Lifted bond wire could not be confirmed in this device.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1059470
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dennis100
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« Reply #59 on: January 09, 2014, 05:30:07 PM »

Model Number 7426
Device Problems Loss of power; Program, failure to
Event Date 04/02/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt woke up feeling fine. Forty five minutes later, the pt knew something was 'not quite right'. He started having more left-sided tremor and fell backwards, but was caught by a family member before he fell. It was also reported that the pt was unable to feel stimulation after a fall down the steps or some other trauma. The pt was unable to adjust stimulation. The pt was seen by his primary hcp the day of the incident. He had a neurology consultation approx 7 days after the original incident. There he had a pronounced increase in left arm tremor. It was harder for him to walk and he had been dragging his left leg more. Voice quality was originally alright, but later the pt noticed that he was stuttering more. He was having some drooling, greater on the right side. Facies were somewhat flat, although he could smile and laugh during the exam. He had micrographia. His last deep brain stimulator programming was four months prior to the exam. Physical exam also revealed left arm rigidity. He had +3 left arm rigidity and a 2-3 tremor, although at times it did quiet down. He had +1 increased tone and rigidity of his right hand. He was unable to do finger taps at all with his left hand and was able to do taps with his right, although he did demonstrate some bradykinesia. Hand pronation and supination again demonstrated bradykinesia bilaterally, left greater than right. He had strong hand grasp bilaterally. He did not drift with eyes closed and arms extended. He had a fine tremor, left greater than right when his arms were extended at rest. He had bilaterally increased tone and rigidity of the lower extremities. He was +2 on his right leg and +4 on his left. There was no tremor of his lower extremities at exam. Foot taps demonstrated decreased amplitude in his right more than left; both demonstrated bradykinesia. He arose independently from a chair using both arms to push up with multiple attempts. While up walking with his walker, he had some bradykinesia, but was able to pick up both of his feet and did not demonstrate any real shuffling at exam. He took a slow turn. No interrogation was possible with the device stimulating his right brain/left side of his body. Left brain neurostimulator settings and impedances were within normal limits. The hcp increased the stalevo 50 mg from 4 to 5 times a day. The pt and his wife were instructed how to increase his medications if needed to control his oral symptoms. The device had been or will be replaced.

 
Manufacturer Narrative
The report was submitted late by the mfr's rep, retraining has been conducted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1068140
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