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Author Topic: Deep brain stimulator - Legs  (Read 40273 times)
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dennis100
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« on: December 06, 2013, 01:15:54 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that a week prior to the date of this report, the patient had a hard time moving his legs and arms. The patient was currently bedridden and unable to move. The patient would like to have the device reprogrammed. It was noted that the patient was currently hospitalized. It was later reported that the patient outcome was unknown. It was suggested that the patient to have programming done in the hospital but the result was unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3447058
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dennis100
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« Reply #1 on: December 07, 2013, 05:54:20 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Product id: 37601, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3387s-40, lot# va0apd4, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0apd4, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6)2013, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 64001, lot# n247539, implanted: (b)(6) 2012, product type: adapter. Product id: 37642, serial# (b)(4), product type: programmer. Patient product id: 3387s-40, lot# v065399, implanted: (b)(6) 2007, product type: lead. Product id: 3387s-40, lot# v065399, implanted: (b)(6) 2007, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. (b)(4).

 
Event Description
It was reported that the patient was implanted with bilateral leads in the subthalamic nucleous (stn). It was noted that since the surgery, the patient had not been ambulatory. It was noted that the manufacturing representative ran impedances, but was not sure ¿whether the therapy issue was due to the patient¿s implantable neurostimulator (ins) having been turned on so soon after surgery, or an impedance issue. ¿ it was further noted that the patient had a device implanted located in the internal globus pallidus (gpi), but it was not active. It was noted that the patient was ¿on 1. 5v after the surgery. ¿ a week later, the patient was at 2. 5v, ¿so some reprogramming had to happen. ¿.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3446433
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dennis100
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« Reply #2 on: December 07, 2013, 06:40:41 AM »

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

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

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dennis100
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« Reply #3 on: December 07, 2013, 06:41:17 AM »

Model Number 37603
Event Date 10/23/2013
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative
Concomitant products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389s-40, lot# va05sek, implanted: (b)(6) 2013, product type: lead. (b)(4). Analysis of the implantable neurostimulator (ins) model# 37603, serial# (b)(4) found no anomaly. Analysis of the extension model# 3708660, serial# (b)(4) found no significant anomaly. The extension body was cut through and the product was segmented.

 
Event Description
It was reported that the patient committed suicide and it was unknown whether it was related to the dbs or not. The patient¿s parkinson¿s disease was reported as having gotten much worse. It was also reported that the patient was experiencing side effects from the deep brain stimulation (dbs), including depression and restless leg syndrome. It was noted that multiple programming sessions were attempted and medications were addressed. 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=3480605
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dennis100
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« Reply #4 on: December 09, 2013, 05:52:09 AM »

Model Number NEU_INS_STIMULATOR
Event Type  Death   Patient Outcome  Death,Required Intervention,Disability
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. It is also possible several events occurred in one patient. The patient information provided in section a is an average for all the patients. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, serial# unknown, product type: lead. (b)(4).

 
Event Description
Franzini, a. , cordella, r. , messina, g. , marras, c. E. , romito, l. M. , carella, f. , albanese, a. , rizzi, m. , nardocci, n. , zorzi, g. , zekay, e. , broggi, g. Deep brain stimulation for movement disorders. Considerations on 276 consecutive patients. J neural transm. 2 011;118(10):1497-1510. Doi: 10. 1007/s00702-011-0656-z. Summary: the links between stn dbs and advanced parkinson disease, and between gpi dbs and dystonia are nearly universally accepted by the neurologists and neurosurgeons. Nevertheless, in some conditions,targets such as the ventral thalamus and the zona incerta may be considered to optimize the results and avoid the side effects. Positive and negative aspects of current dbs treatments justify the research of new targets, new stimulation programs and new hardware. Since 1993, at the istituto nazionale neurologico ¿¿carlo besta¿¿ in milan, 580 deep brain electrodes were implanted in 332 patients. 276 patients were affected by movement disorders. The dbs targets included stn, gpi, voa, vop, vim, cm¿pf, czi, ic. The long-term follow-up is reported and related to the chosen target. Dbs gave a new therapeutic option to patients affected by severe movement disorders, and in some cases resolved life-threatening pathological conditions that would otherwise result in the death of the patient, such as in status dystonicus, and post-stroke hemiballism us. Nevertheless, the potential occurrence of severe complications still limit a wider use of dbs. At today, the use of dbs in severe movement disorders is strongly positive even if further investigations and studies are needed to unveil potential new applications, and to refine the selection criteria for the actual indications and targets. The experience of different targets may be useful to guide and tailor the target choice to the individual clinical condition. Reported events: 1. 2 patients had a massive brain hemorrhage with a fatal outcome. 2. 6 patients had permanent neurological deficits due to deep hemorrhage 3. 8 patients had transient neurological deficits due to deep hemorrhage. 4. 7 patients had post-operative seizures. 5. 26 patients had hardware removed due to infection. 6. 6 patients had hardware removed due to infection and had a cerebral abscess at the origin of the stereotactic trajectory. 7. 30 patients had a hardware failure. 8. 20 patients had a late electrode migration. 9. 2 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had a brain hematoma with hemiplegia. 10. 1 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had presented an unexplained fracture of the extracranic portion of the lead. It was noted that the patient underwent a successful lead replacement. 11. 2 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had monolateral removal of their systems due to infection. 12. 17 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had hypophonia. 13. 11 patients with parkinson¿s disease had a bilateral deep brain stimulation (dbs) implanted in the subthalamic nucleus (stn) did not have an improvement in their speech item, weight gain, and had dysarthria. 14. 1 pediatric patient suffering from a sever from of secondary dystonia had bilateral implantation ofdeep brain stimulation (dbs) system in the globus pallidus interna (gpi) and was successfully treated for 2 years before the stimulation device on the right side became infected because of skin erosion of the head along the path of the connector. It was noted that a right pallidotomy was performed by the dbs electrode before its subsequent definitive removal. 15. 4 patients suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had migration of the electrode. It was noted that the complication was successfully managed. 16. 2 patients suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had breakage of the electrode. It was noted that the complication was successfully managed. 17. 5 patients suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had an infection. It was noted that the complication was successfully managed. 18. 1 patient suffering from dystonia had bilateral implantation of deep brain stimulation (dbs) system in the globus pallidus interna (gpi) and had an intracranial hemorrhage. 19. 4 patient suffering from parkinson¿s disease with levodopa induced dyskinesia developed severe akinesia resistant to levodopa therapy after 4 years of chronic stimulation. 20. 3 patients had bilateral thalamic implants and had speech impairment. 21. 3 patients with severe syndromes characterized by high amplitude distressing tremor of bilateral limbs and head, and were completely invalid. It was further reported that these patients did not have restoration of finalistic movements and bilateral surgery was associated with speech impairment. 22. 1 patient with severe syndromes characterized by high amplitude distressing tremor of bilateral limbs and head, and was completely invalid. It was further reported that this patient did not have restoration of finalistic movements and bilateral surgery was associated with speech impairment. Additionally it was noted that surgery was followed by a relapse of the demyelinating disease. 23. 19 patients affected by advanced parkinson¿s disease had bilateral implants in the pre-lemniscal radiation (raprl) and had an incident of speech impairment of 36% and depression of 18%. 24. 4 patients affected by advanced parkinson¿s disease had asymmetrical implants in the pre-lemniscal radiation (raprl) and in the causal zona incerta (czi) on the contralateral side and had an incident of speech impairment of 36% and depression of 18%. Please refer to manufactures report # 3007566237-2013-02368 for additional information on a related event. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3233746
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dennis100
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« Reply #5 on: December 30, 2013, 07:24:10 AM »

Model Number 7426
Event Date 08/05/2004
Event Type  Injury   Patient Outcome  Other,Hospitalization,Life Threatening,Required Intervention,Disability
Event Description
"cramps in left toes brought on violent convulsive bilateral synchronous agonizing motions legs, arms, ~6/sec, shocks felt like 208 volt shocks in past career as e. E. Radiated over 20 volts/per meter, stopping electric wheelchair, took over ambulance's pt monitor till shut off. Would restart spontaneously 612,000 over-voltage pulses/hour caused cramps, strong tremors, difficulty breathing suspect damage to left motor nerves for without neurostimulator left hand now steady, suspect very large electric pulses performed thalotomy. Also seem to have undergone form of operant conditioning, xxw/o neurostimulaton get all symptoms except for less violent trembling (strong tremors no sensation of electrocution). ".

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« Reply #6 on: January 01, 2014, 05:05:02 AM »

Model Number 3387
Device Problem Device remains implanted
Event Date 05/17/2006
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
Manufacturer is attempting to clarify written statements from the healthcare provider. A follow up report will be sent if these statements have been clarified.

 
Event Description
The patient's son reported the second lead was implanted in 2006. Within 24 hours, the patient exhibited signs of loss of function. Caller stated a ct scan showed fluid accumulation around the lead wire. The patient was partially paralyzed and unable to speak. Hcp reported patient symptoms included confusion, disorientation, difficulty finding words and inattentiveness after surgery. No weakness, fever, disability or hemiparesis was reported that day during non-focal motor exam. The event occurred eight hours post placement of the left stn deep brain stimulation electrode. The right electrode had been placed a month prior without incident. Ct scan showed air pockets and no edema after surgery. A ct scan performed two days later showed vasotonic edema in the cortex. A subsequent ct scan the next week revealed persistent vasotonic edema. The patient was readmitted to the hospital the day after the left electrode was placed and then sent to rehabilitation. During hospitalization, the patient's left leg became more stiff and dystonic. Hcp reported this was possibly due to lack of use and was partially present before stn deep brain stimulation placement. No surgical intervention performed. The patient's status returned to baseline over one month. The patient's motor exam returned to pre op by two months. Left leg dystonia was substantially improved with stimulation. Hcp reported by october or november 2006, the patient had no residual motor or cognitive side effect, and remarkable impact on parkinson's symptoms as the hcp adjusted the deep brain stimulation electrodes. Therapy is working well and the patient's thinking cleared.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=796262
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dennis100
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« Reply #7 on: January 01, 2014, 05:06:09 AM »

Model Number 7426
Device Problems Device remains implanted; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Type  Malfunction   Patient Outcome  Other
Event Description
Information received from a patient to the mfr indicates that after a study had been performed on their leg, the patient experienced symptoms of dizziness. Inspection by the patient after the study found the device turned off. It is unknown whether the patient told the study personnel prior to the procedure about the implanted neurostimulator. Additional information provided by the patient indicates the device also turns off after the patient passes through theft detectors. The medtronic representative reviewed compatibility information with the patient (electrical devices or magnets that may interfere with the product), and also redirected the patient to report symptoms to their physician. Additional information has been requested by medtronic from the healthcare professional regarding the reported event. A supplemental mdr follow-up report will be sent to fda if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=844031
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dennis100
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« Reply #8 on: January 01, 2014, 05:07:07 AM »

Model Number 7426
Device Problem Device remains implanted
Event Type  Other   Patient Outcome  Other
Event Description
Hcp reports patient presented in 2006, with symptoms of left sided leg weakness and lactation. In approx four months later, the patient now had diffuse pain which had started in left hand and spread to entire body. The symptoms improved with the stimulation off. A doppler study and head ct were performed with the results pending. The device system was interrogated and revealed no problems. The hcp recommended follow up with a neurologist, endocrinologist and pain management clinic for further testing with device. The hcp will follow up after consultation is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=757933
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dennis100
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« Reply #9 on: January 02, 2014, 03:02:52 AM »

Model Number 7479B
Device Problem Explanted
Event Date 03/25/2006
Event Type  Other   Patient Outcome  Other
Event Description
Hcp reports patient presented in the emergency room with paralysis of both legs. Patient underwent total device explantation secondary to lower limb paralysis and evidence of hematoma with cordal edema by mri. Following surgery patient was able to move toes and does feel pain. Patient left the hospital against medical advice. The hcp notes a history of psychological issues. The device was explanted but not returned to the manufacturer for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=707806
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« Reply #10 on: January 05, 2014, 01:57:49 PM »

Model Number 3387
Device Problems Device remains implanted; Low impedance; Implant, reprogramming of
Event Date 10/25/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The hcp reported the patient experienced intermittent right leg cramping. Dystonia, dyskinesia and pain. Further investigation revealed a short circuit depleted the neurostimulator prematurely. Impedances on electrodes 0 and 1 were 59 ohms. The neurostimulator and one extension were replaced; impedances still indicated a short circuit (58 ohms and 301 ua). The representative programmed around the electrodes, using electrodes 2 and 3 instead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=971917
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« Reply #11 on: January 05, 2014, 02:19:33 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.

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« Reply #12 on: January 08, 2014, 05:25:29 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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« Reply #13 on: January 08, 2014, 05:26:15 PM »

Model Number 7426
Device Problems Performance; Loss of power; Device remains implanted; Unit inactivated; Implant, reprogramming of; Suspect EMI; Unable to interrogate
Event Date 08/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient reported, that he recently noticed the ins did not seem to be working. He checked with the patient programmer and the device was off; there was no output and he couldn't communicate with the ins. He may have been near a magnet, causing it to turn off. When he turned the ins back on, he felt a strong painful stimulus in his leg, arm and face on the right side, prior to output failure. A follow-up, the physician was unable to "get any real contact" with the device to reprogram it and the device was turned off. Additional information has been requested from the physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=915169
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« Reply #14 on: January 08, 2014, 05:26:59 PM »

Model Number 3387
Device Problems Performance; Device remains implanted; Implant, repositioning of
Event Date 04/01/1999
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt reported that subsequent to dbs system revision (lead and bilateral ipg replacement) in 1999, he experienced some tingling in his right leg, arm and on the right side of his face. Two months later, the lead was "adjusted slightly" and the situation was improved, but they were never able to get complete control of the right-sided tremor without inducing uncomfortable tingling on that side. The pt is left-handed, so right-sided symptom control was less important to him. He also would not inactivate right-sided therapy due to feeling uncomfortable stimulus any time that side was turned on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=915030
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« Reply #15 on: January 08, 2014, 05:27:43 PM »

Event Type  No Answer Provided   Patient Outcome  Disability,Required Intervention
Manufacturer Narrative
 
Event Description
Journal reference: parra, j et al. "serious restless legs syndrome after bilateral subthalamic stimulation for treatment of a female pt with parkinson's disease. " revenurol 2006; 42(12): 766. The article lists information suggesting a female pt being treated with dbs for symptoms associated with parkinsons disease developed restless leg syndrome 20 days post bilateral dbs lead placement surgery. Symptoms deteriorated the pts quality of life, led to depression and resulted in a number of er admissions. The pt was treated with tramadol and repirinol. Author indicates that the decrease in dopaminergic medication with the use of dbs may have contributed to the pts rls condition. Reportable events: dbs ipg (stimulator) - pt developed restless leg syndrome with depression. Dbs lead (n=2) - pt developed restless leg syndrome with depression.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=921681
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« Reply #16 on: January 08, 2014, 05:52:38 PM »

Model Number 3389
Device Problems Device remains implanted; Implant, reprogramming of
Event Date 08/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt reported that subsequent to surgical revision in april 2007, he no longer has symptom relief; he has experienced problems with speech, balance and weak legs. The physician has reprogrammed the dbs system several times. The pt rep redirected the pt to report symptoms to the hcp. Add'l info has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=907494
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« Reply #17 on: January 08, 2014, 05:53:21 PM »

Model Number 3389
Event Type  Injury   Patient Outcome  Other
Event Description
Gan et al. "bilateral subthalamic nucleus stimulation in advanced parkinson's disease, there year follow-up", journal of neurology (2007) 254: 99-106. The study objective is to assess the long-term efficacy and safety of chronic bilateral stimulation of the subthalamic nucleus (stn) in consecutive pts. The article describes results of a study involving total pts being treated with bilateral-stn dbs for advanced parkinsons disease. Parkinsonian status was investigated postoperative, at 1 year and 3 year intervals. Both transient and long lasting complications were included in the article. Three pts experienced restless leg syndrome post dbs implants. No info was provided concerning treatment and outcomes.

 
Manufacturer Narrative
Due to 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 likely that each pt may have experienced more than one complication related to a specific event. See scanned pages.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=930530
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dennis100
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« Reply #18 on: January 09, 2014, 10:19:32 AM »

Model Number 3387
Device Problem Implant, reprogramming of
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
 
Event Description
Journal ref: handforth et al. "deep brain stimulation of the subthalamic nucleus as adjunct treatment for refractory epilepsy. " epilepsia 2006; 47(7): 1239-41. This article describes two case reports of bilateral subthalamic deep brain stimulation (dbs) for refractory partial-onset epilepsy. Reportable event: a female with seizures since age 1 yr after head trauma was treated with bilateral subthalamic deep brain stimulation. The pt had stimulation-associated disequlibirum and leg dyskinesias that resolved within 2hrs after reprogramming. A 10-day period of disinhibited talking and imbalance promptly resolved with reduction of right-lead voltage.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1000105
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« Reply #19 on: January 09, 2014, 10:20:27 AM »

Model Number 3387
Device Problems Implant, repositioning of; Implant, reprogramming of
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Journal ref: handforth et al. "deep brain stimulation of the subthalamic nucleus as adjunct treatment for refractory epilepsy. "epilepsia 2006; 47(7): 1239-41. This article describes two case reports of bilateral subthalamic deep brain stimulation (dbs) for refractory partial-onset epilepsy. Reportable event: a female with seizures since encephalitis at age six months was treated with bilateral subthalamic deep brain stimulation. At surgery, distortion by atrophy and prior craniotomy led to a left-lead assignment more dorsal than that of the right. After a second surgery, an mri indicated the left lead was now intra-stn. Adverse events of left arm and leg dyskinesia, diplopia, and disequilibrium resolved with reprogramming.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1000104
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« Reply #20 on: January 09, 2014, 10:21:16 AM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002342
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« Reply #21 on: January 09, 2014, 10:22:30 AM »

Model Number 3387
Device Problem Device remains implanted
Event Date 11/27/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported the patient status one-day post dbs revision; interrogation of the left-sided system had revealed one impedance value remained less than 50 ohms. The interrogation numbers obtained were: electrode impedance 646, 654, 850, 789, <50, 1076, 1058; other values were deemed to be within normal limits. The left-battery impedance was 927 with current of 29, and battery voltage was 3. 74, the battery "was reading ok. " the patient electrode settings were 3+, 0-, amplitude was 1. 8, pulse width was 90, and pulse rate was 130. When the hcp "tried to go higher on his amplitude the right-side of his face went numb, and his ability to speak decreased. " the pulse width and pulse rate were turned down to the settings listed above, but they "could not go any higher on the amplitude without getting side effects. " the patient stated he was comfortable at the prior settings and his right arm tremor was gone. He had not taken any medications since the previous evening and the patient was discharged to home (nursing home), in 2007. At follow-up the following month, the patient reported he felt "the same" and was tired; he had continued to work with physical therapy and had felt stronger. The patient could "walk about 5 steps before his legs give out. " there had been no falls or syncope symptoms subsequent to hospital discharge. The patient had turned dbs therapy off; he attributed increased weakness and diarrhea, including the loss of bowel control to the devices. He had the onset of gastrointestinal upset and diarrhea within 2-3 hours when stimulation is turned on that resolved when therapy is turned off. The patient had "repeated this scenario with consistent results, unable to use dbs implant," the patient had left stimulation off to avoid the affects of diarrhea. On the same day, (visit notes continued): the patient continued with right-sided tremor, symptoms were greater in the right-hand than the leg; the patient reported "trouble turning in at night. " he was eating and drinking well and had used lortab for right-hip and back pain with good relief. Results of physical exam had shown the patient was well-groomed, well-nourished in no acute distress; his attention span and concentration were normal and in no acute distress; his attention span and concentration were normal and appropriate for his age and education level. The patient's speech had been clear, his smile was deemed symmetrical and intact. There was right-upper extremity resting tremor, they were unable to test gait. The patient would continue with current medications, he would take rozerem every night. At follow-up five days later, the dbs therapy had remained off due to uncomfortable bowel movements. The patient had indicated that he had not experienced uncontrollable bowel movements subsequent to turning off stimulation therapy. It was also "noted that before this battery change he was up and walking, but is now in a wheelchair, and he stated that his legs felt like rubber. " the hcp indicated that the patient had been programmed until right-facial pulling was detected and the patient reported tingling in his right-hand and right-foot; "it was very difficult to turn up any of the controls because he would get right facial pull and tingling in his right hand and foot. " system adjustments were reported as: electrode settings, 3+, 0-, amplitude 1. 6, pulse with 90, pulse rate 100. Impedance readings were 868, 881, 1022, 1049, <50, 1227, 1424, 1227, 1441, 1239. Battery impedance was 1132, current 25, battery voltage was 3. 75, the reading was "ok. " the sinemet cr 50/200 medication was increased to twelve tablets daily; all other medications remained unchanged. The next day, the patient was seen at the clinic for suture removal from the scalp post-replacement of the left-sided extension; the incision had been well-healed, the sutures had been removed without difficulty. The patient was seen for follow-up the following month, visit notes had been unavailable. The patient would be referred for further evaluation of the dbs system and would be referred to the neurosurgeon, if needed. The patient outcome had been reported as non-serious illness or injury related to gi symptoms of diarrhea. Refer to mfr reports #6000153200704467, #2182207200800451, #2182207200800452, #6000153200800453, #2182207200800454.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=989147
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« Reply #22 on: January 09, 2014, 10:23:10 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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« Reply #23 on: January 09, 2014, 01:43:29 PM »

Model Number 3387
Device Problems High impedance; Device remains implanted
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the pt does not receive good therapeutic effect with the right neurostimulator. The pt's speech improves with the neurostimulator off, however, the pt's tremor returns. The pt experiences some leg dystonia on the right side (left neurostimulator). At the time of this report the pt was at the clinic, in fair condition. Impedance readings were greater than 2000 ohms on both sides. X-ray of the system did not reveal any obvious issues. Therapy impedances were 828 with a current of 42 ma, and 1392 with a current of 27 ma. The hcp mentioned the lead was not in the optimal location.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1052744
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« Reply #24 on: January 09, 2014, 01:44:22 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
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« Reply #25 on: January 09, 2014, 05:43:05 PM »

Model Number 7428
Device Problem Replace
Event Date 10/31/2006
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
It was reported the pt underwent removal of the bilateral gpi dbs leads and implantation of stn placed leads. The pt had the dbs sys placed in 2005. The pt did not receive benefit. The pt became progressively more disabled despite implantation of dbs. The pt was evaluated prior to the revision. The pt's only new complaint was that he noted some difficulty urinating while standing although he felt he was able to fully empty his bladder while in a sitting position. He had no dysuria or other urinary tract complaints. The pt had been started on lasix 20 mg/day for peripheral edema in 2008. It had been somewhat effective in improving the edema in his hands and ankles. The pt had no shortness of breath, chest pain, or other cardiopulmonary complaints. The pt was admitted to the hosp in 2006. The pt's physical exam revealed blood pressure 112/64, heart rate 76, respirations 16, pt's weight which was decreased by two pounds since the month before. Exam was otherwise unchanged from previous exams. It was notable for an irregular cardiac rhythm, dyskinesias of the arms and legs, slow shuffling gait, and abnormal posture with the upper body held in a forward, flexed, position. There was trace to 1+ pedal edema noted. The leads were replaced. The new leads were connected to the previously implanted extensions and the generators were tested. The impedances were found to be normal. The procedure was well tolerated. The pt was discharged on two days later. Prognosis for improvement of pd motor symptoms was good.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1066633
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« Reply #26 on: January 09, 2014, 05:44:01 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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« Reply #27 on: January 09, 2014, 05:45:53 PM »

You know what it is.
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« Reply #28 on: January 12, 2014, 06:14:02 PM »

Model Number 3389S
Device Problem Implant, reprogramming of
Event Date 09/14/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt reported that she fell. Following the fall the pt experienced leg numbness which was mostly at night. She also reported that all of her right toes curled down, and her left big toe curled upward. Add'l info received from the hcp reported that the pt did not have any symptoms. The pt's neurostimulator was reprogrammed in 2008. The pt recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1014491
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« Reply #29 on: January 12, 2014, 06:14:37 PM »

It's criminal
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