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Author Topic: Deep brain stimulator - Legs  (Read 42599 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. ¿.

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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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« 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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« 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.

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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.

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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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« 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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« Reply #30 on: January 12, 2014, 06:16:13 PM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: piboolnurak et al. "levodopa response in long-term bilateral subthalamic stimulation for parkinson's disease" movement disorders/2007/22/7/990-997. This article describes a long-term follow-up of 33 pts with dbs therapy for parkinson's disease. Reportable event: there was a total of 2 adverse event reports of restless leg syndrome during the follow-up. No add'l info or outcomes were provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1015659
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« Reply #31 on: January 12, 2014, 06:17:02 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: tir et al. "exhaustive, one-yr f/u of subthalamic nucleus deep brain stimulation in a large, single-center cohort of parkinsonian pts. " 2007/61/2/297-304. This article describes a study that enrolled consecutive pts with parkinson's disease who were treated with bilateral stn-dbs. The pts were followed for a period of 12 mos. Reportable event: two pts experienced a pulmonary embolism secondary to leg phlebitis. Good outcomes were achieved with the use of anticoagulation therapy.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019054
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« Reply #32 on: January 13, 2014, 01:56:40 AM »

Model Number 3387
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 06/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that in 2007 while the stimulation was on, the patient experienced a headache and numbness in her legs and arms. There was no known accident or incident related to the symptoms. The patient was currently at home and had an appointment with her hcp. Additional information has been requested from the hcp, 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=1045939
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« Reply #33 on: January 13, 2014, 01:58:10 AM »

Model Number 7426
Device Problems Battery failure; Replace; No telemetry
Event Date 12/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported in 2007, that the implanted device could not be interrogated using the pt programmer; the pt's wife had confirmed that only the 9v battery light would illuminate. There were no symptoms reported and the rep redirected the pt to follow up with the physician. It was reported in jan 2008, that the pt had visited the hcp regarding the event (follow-up dates were not provided). The device had not been reprogrammed and problems with the implanted system were ongoing. Results of a brain ct scan in 2007, shows tissue atrophy and a lead is noted in the left ventricle. The rep had interrogated the system (date of exam was not reported), and found the pulse generator battery depleted. The pt had experienced symptoms of increased tremor and muscle stiffness in the right leg and the pulse generator was replaced for battery failure. The pt had recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1030852
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« Reply #34 on: January 13, 2014, 01:59:11 AM »

Model Number 3387
Device Problem Implant, repositioning of
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: linhares; protocol of procedure in deep brain stimulation for treatment of parkinson disease/sinapse /2007/7/1/23-27: this paper describes a clinical study of dbs for treatment of parkinsons disease and attempts to put a standardization to the procedures and outcome measures. One pt experienced a intracerebral symptomatic hemorrhage during the procedure that resulted in grade 4/5 lower limb paresia. One pt experienced a system infection after rejection of the material and cutaneous exposure. One pt had a serious case of depression which led to repositioning of the electrode. Mfr was not identified.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1026785
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« Reply #35 on: January 13, 2014, 08:33:34 AM »

Model Number 3389
Device Problems Device remains implanted; Unit inactivated; Implant, reprogramming of
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The spouse had reported on 11/07, there had never been therapeutic effect when stimulation therapy was turned on, the pt's symptoms had improved (he was better), with stimulation turned off. The hcp provided summary notes for pt follow-up between 2 months in 2007, timeframe. All impedance checks in 2007, has been normal (exact values were not provided), the unilateral dbs system had been reprogrammed several times without improvement. Symptoms of neurological deficit was described as "freezing. " the pt was seen in 2007, for initial reprogramming after dbs placement. Initial settings were 1-, case +, 2. 0 v, 90 unsec. When the voltage was turned up to 2. 5 v the pt had "slight skewed diploia. " subsequent settings were 2-, case +, 2. 0 v, 90 unsec, which caused a "dramatic reduction in dyskinesia. " a follow-up 3 days later, the pt had improved and his medications lasted 2. 5 to 3 hrs, versus 2 hrs. It was noted when medications wore off the pt had difficulty walking; he would freeze and would either hop from place to place, to break the freeze, or he would lean into furniture and drag his legs behind him. When the medications worked, he had dyskinesia. The pt omitted levodopa prior to exam; he had no dyskinesia, his speech was clear and he had not seemed distractible or inattentive. There was mild upper extremity and mild to moderate lower extremity rigidity; he had obvious freezing upon initiating and maintaining gait. The pt could not walk effectively for more than a few feet. During reprogramming, setting were 2-, case +, and the voltage was increased from 2. 0 to 3. 0 v, initially keeping the pulse width at 90 usec with no change seen in tone, bradykinesia, or freezing. When the pulse width was widened to 120 usec, the pt's speech became muffled; he had appeared less attentive while conversing and the pulse width was returned to 90 usec. The pt took his medications, which then showed mild right-sided and moderate to severe left-sided dyskinesia, his gait had been normal with good stride length and balance, with stimulation on. At follow-up on 09/21/07, the pt had suffered a fall that required sutures (no details were provided). Settings at 2-, case +, 3. 0 v, showed some on freezing, his gait became worse when off. Settings of 2-, case +, 3. 5 v, still showed on freezing with improvement. Additional settings of 1+,2-, 2. 0 v, 90 usec, and 185 hz showed no obvious on freezing, there was some residual freezing but his medications appeared to be effective for a longer period of time. The pt would discontinue comtan. Approx 2 weeks later, the pt was seen for "further dbs titration"; symptoms of moderate left-sided and mild right-side dyskinesia were noted. Upon initiating gait, there was slowness to move the right-foot and slight freezing in the right lower extremity (rle). When settings changed from 2. 0 to 2. 5 v, the pt showed significant freezing of the rle upon walking. The voltage was increased to 3. 0 v, and the freezing became worse; subsequently the voltage was decreased to zero and freezing appeared to improve. The anode and cathodes were reversed to (1-, 2+), at a setting of 2. 0 v, and 90 usec, which showed improved gait. The pt was discharged at 2. 0 v, and was referred to physical therapy. A follow-up about 2 weeks later, the pt continued to have difficult freezing, which occurred prominently between doses of levodopa, but had also occurred while on levodopa medication. The symptoms were deemed to be a "side effect of dbs off freezing," which had been less prominent pre-operatively, the on freezing was new. On exam he had moderately severe left-sided and mild right-side dyskinesia; freezing was noted upon gait initiation. His speech was normal. Dbs therapy was inactivated; voltage was set to 0 v and the device was turned off. The pt anticipated travel in the following month. Refer to mr report #3004209178200704569.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1006019
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« Reply #36 on: January 13, 2014, 10:54:20 AM »

Model Number 3387
Device Problems Performance; Device remains implanted
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Disability,Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported that following stage 1, bilateral lead placement in 2007, "they had noted a change in the patient". The physician indicated the patient had suffered a stroke (the exact date of onset was not reported); the event had been attributed to the lead device. The patient had been seen for one post-operative visit with the surgeon (exact date was not given). The patient had hemiplegia; it was unknown which side had been affected. She had received short-term rehabilitation (dates and type of facility were not provided), and had subsequently been discharged to home. The patient's condition was non-ambulatory; she had been able to walk prior to the surgery. The patient reported in 2008, that the system had been reprogrammed in 2008. No symptoms had been provided but the patient stated that after reprogramming "it helped for a short while". There had been painful right leg spasms, that had occurred whenever she sat down. She had tried increasing her parkinson's medications and achieved symptom suppression for a few hours before spasms would return. At follow-up for programming the following month, the hcp stated that the patient had been responding well to treatment but at times does have symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1013780
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« Reply #37 on: January 14, 2014, 11:25:43 AM »

Model Number 7426
Device Problems Replace; Inappropriate shock
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
When the pt turned his stimulation on he experienced a shocking sensation in the right side of his body which lasted 5-7 seconds. It started in his right arm, traveled through his body to right leg and toes, and then disappeared. The symptoms coincided with the car crash. The pt did not feel the shocking after switching to a different pt programmer. The pt also experienced shocking on his left side (see mfg report # 3004209178200805581). The bilateral pulse generators and left sided extension were replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1178930
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« Reply #38 on: January 14, 2014, 11:26:24 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Death   Patient Outcome  Death
Event Description
Journal reference: guehl d, vital a, cuny e, et al. Postmortem proof of effectiveness of zona incerta stimulation in parkinson disease. Neurology. 2008;70(16, pt. 2): 1489-1490. In this study, we report the first pathologically proven case of direct bilateral zi stimulation which dramatically improved the cardinal symptoms of pd in a pt implanted for severe pd 6 years previously and who suddenly died. A man was proposed deep brain stimulation (dbs) because he had severe pd for 13 years that had reached the stage of motor fluctuations with incapacitating levodopa-induced dyskinesia. He was operated on with proven effectiveness during 5 years of follow-up. Reportable event: six years after surgery, the pt was admitted to the hosp for generalized dyskinesia associated with lower leg dystonia, for which the daily dosage of l-dopa was slightly reduced from 700 to 500 mg/day. Thereafter, he exhibited severe incapacitating dystonia of the lower legs that was resistant to apomorphine. Two days later, his dystonia was more diffuse and affected the upper limbs and the trunk. The pt fell into a coma with malignant hyperthermia, suggesting the diagnosis of rhabdomyolysis related to severe incapacitating dystonia. Screening for bacterial infections was negative. The clinical picture was complicated by the occurrence of liver insufficiency and he died from hemorrhage after 2 wks of intensive resuscitation. Our histologic data showed that none of the contacts was located within the stn, probable because we were not able to perform peroperative electrophysiologic recordings to guide the targeting in this subject. The electrodes passed just above the stn and were located within the zi. Therefore, the dramatic improvement in rigidity, akinesia, and tremor appears to be closely associated with zi stimulation. (see scanned pages).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069224
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« Reply #39 on: January 14, 2014, 11:27:31 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: lohmann e, welter m-l, et al. Are parkin patients particularly suited for deep-brain stimulation mov disord. 2008; 23(5): 740-743. Patients with parkin mutations are known to have slower pd progression and a better response to levodopa at lower doses than patients with idiopathic parkinson's disease. To determine the effects of deep brain stimulation (dbs) on such patients, we have compared the follow-up after surgery of 7 patients with one parkin mutation, 7 patients with two parkin mutations, and 39 patients without parkin mutations. Twelve to 24 months after bilateral stn stimulation neurosurgery, the daily doses of levodopa equivalent were significantly lower in patients with two parkin mutations, indicating that these patients benefit from dbs, and they might have more durable results. Reportable event: one complication was noted at 12 month follow-up. One of the patients with two parkin mutations experienced a severe atypical ballistic dyskinesia in the legs after surgery, reminiscent of similar complications in some pd patients who underwent neural transplantation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069549
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« Reply #40 on: January 14, 2014, 10:30:03 PM »

Model Number 7428
Device Problem Device remains implanted
Event Date 07/28/2008
Event Type  Injury   Patient Outcome  Disability,Hospitalization
Event Description
When inserting one of the electrodes, the surgeon grazed a blood vessel producing a slow blood leak. There was no indication that anything was wrong during the surgery. The manufacturer's field representative reported that the hemorrhage may be attributed to the right-sided lead and that the hemorrhage was below that, at the tip of the lead level. There were no blood pressure or heart rate spikes during surgery. Recordings and macrostimulation during surgery were good. It appeared the patient was going to have a great outcome. About 5 hours after the implantation of the deep brain stimulator leads, a blood clot the size of a baseball formed in the patient's brain. The patient was taken back to surgery and 89% of the clot was removed. A computerized tomography scan revealed that some of the blood had leaked into the third and fourth ventricles surrounding his brain stem. The patient was admitted to the intensive care unit. He was given supplemental oxygen. The patient was fed through a nasogastric tube initially. A permanent gastric tube was surgically placed later. The damage to the left side of the brain had partially paralyzed the left side of his body. Though unable to open his eyes or speak, the patient was able to acknowledge his family by squeezing his right hand. The patient's family believed his condition had improved during the week following surgery. The patient was moved out of the intensive care unit to a skilled nursing facility where he was given speech therapy, physical therapy and other skilled specialist. Approx 6 weeks after the surgery, the pt had lost 15 pounds. He had difficulty moving his left leg. He was able to swallow ice chips at that time. The pt was able to communicate nonverbally with his family and was able to form a few words. He slowly gained better use of his right hand. The pt was making progress using equipment in the nursing facility. Much of the info above was reported via a call. 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=1162669
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« Reply #41 on: January 14, 2014, 10:30:55 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Literature: biolsi b, cif l, fertit he, robles sg, coubes p. Long-term follow-up of huntington disease treated by bilateral deep brain stimulation of the internal globus pallidus. J neurosurg. 2008;109(1):130-132. Deep brain stimulation is now accepted as a safe and efficient treatment for movement disorders including selected types of dystonia and dyskinesia. Very little, however, is known about its effect on other movement disorders, particularly for "choreic" movements. Huntington disease is a fatal autosomal-dominant neurodegenerative disorder characterized by movement disorders, progressive cognitive impairment, and psychiatric symptoms. Bilateral chronic stimulation of the internal globus pallidus was performed to control choreic movements in a man with a 10-year history of huntington disease. Chronic deep brain stimulation resulted in remarkable improvement of choreic movements. Postoperative improvement was sustained after 4 years of follow-up with a marked improvement in daily quality of life. Reportable event: bradykinesia in the lower extremities was visible 2-3 weeks after dbs, which improved following treatment with levodopa (187. 5 mg). Four years after surgery the improvement of chorea remained stable. We observed a clear improvement in motor control when comparing stimulation-on and -off conditions at 4 years. Neuropsychological assessment again found a moderate subcortical cognitive dysfunction with no evolution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1163605
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« Reply #42 on: January 14, 2014, 10:31:43 PM »

Model Number 7428
Device Problem Device remains implanted
Event Date 07/28/2008
Event Type  Injury   Patient Outcome  Disability,Hospitalization
Event Description
When inserting one of the electrodes, the surgeon grazed a blood vessel producing a slow blood leak. There was no indication that anything was wrong during the surgery. The manufacturer's field representative reported that the hemorrhage may be attributed to the right-sided lead and that the hemorrhage was below that, at the tip of the lead level. There were no blood pressure or heart rate spikes during surgery. Recordings and macrostimulation during surgery were good. It appeared the patient was going to have a great outcome. About 5 hours after the implantation of the deep brain stimulator leads, a blood clot the size of a baseball formed in the patient's brain. The patient was taken back to surgery and 89% of the clot was removed. A computerized tomography scan revealed that some of the blood had leaked into the third and fourth ventricles surrounding his brain stem. The patient was admitted to the intensive care unit. He was given supplemental oxygen. The patient was fed through a nasogastric tube initially. A permanent gastric tube was surgically placed later. The damage to the left side of the brain had partially paralyzed the left side of his body. Though unable to open his eyes or speak, the patient was able to acknowledge his family by squeezing his right hand. The patient's family believed his condition had improved during the week following surgery. The patient was moved out of the intensive care unit to a skilled nursing facility where he was given speech therapy, physical therapy and other skilled specialist. Approx 6 weeks after the surgery, the pt had lost 15 pounds. He had difficulty moving his left leg. He was able to swallow ice chips at that time. The pt was able to communicate nonverbally with his family and was able to form a few words. He slowly gained better use of his right hand. The pt was making progress using equipment in the nursing facility. Much of the info above was reported via a call. 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=1162669
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« Reply #43 on: January 16, 2014, 12:42:16 AM »

Model Number 7428
Device Problem Pocket stimulation
Event Date 10/01/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported the pt experienced a loss of therapeutic effect from their deep brain stimulator. The symptoms were noticed about ten days prior. There was no known incident related to the onset of the symptoms. The physician has had to increase the pt's medications. The pt was seen in the clinic. Movement did not cause changes in the stimulation but palpating the device did cause changes in the stimulation. Palpation of the device pocket and lead extension area caused a sensation down the arm and leg. Add'l 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=1257496
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« Reply #44 on: January 16, 2014, 06:40:14 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 #45 on: January 16, 2014, 06:41:41 AM »

Model Number 7428
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 10/01/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported the patient was experiencing nervousness and shaking for the last 2 to 3 days. The left hand and leg seemed to be the most affected. The patient had experienced a fall approximately ten days prior. Since the fall, walking had gotten substantially worse. The patient had gone to the er (date unknown) and was given benadryl, which seemed to calm her nerves. The patient was at home at the time of the report. Additional information 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=1277784
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« Reply #46 on: January 17, 2014, 12:53:50 PM »

Model Number 7426
Device Problems High impedance; Device remains activated; Inappropriate shock
Event Date 01/19/2006
Event Type  Injury 
Manufacturer Narrative
 
Event Description
The patient experienced uncomfortable shocking sensation in his jaw and down the side of his face, arm, or leg (it was unclear which body side). The impedances of electrode 0 on right lead was greater than 2000 ohms; the current was 11 microamperes, suggesting an open circuit. The impedance on electrode 0 of the left lead was also greater than 2000 ohms; the current was 7 microamperes, suggesting an open circuit. The hcp palpated all of the implanted components but was not able to reproduce any shocking sensation to the patient. X rays were performed and did not reveal any obvious wire fractures or disruptions. The right-sided deep brain stimulator had a battery voltage of 3. 6 volts and was replaced. The extension was replaced at the same surgery. Additional surgery was being considered if the shocking continued. Please see mfr. Report # 3004209178200900214.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1287236
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« Reply #47 on: January 17, 2014, 12:54:43 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 #48 on: January 17, 2014, 09:12:37 PM »

Model Number 7426
Device Problem Device remains implanted
Event Date 10/23/2008
Event Type  Injury   Patient Outcome  Disability
Event Description
It was reported that the pt experienced no therapeutic effect and a change in gait with difficulty walking and leg weakness two days after lead implant. It was unk if the pt's symptoms were related to the implant or spinal stenosis. Additional testing was pending. Additional info has been requested, but was not available as of the date of this report. Reference mfr. Report # 3004209178200901277.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1325823
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« Reply #49 on: January 17, 2014, 09:13:50 PM »

Model Number 7426
Device Problems Other (for use when an appropriate device code cannot be identified); Implant, reprogramming of
Event Date 02/11/2009
Event Type  Malfunction 
Manufacturer Narrative
For return to default settings.

 
Event Description
The patient started having dystonia symptoms starting 2 days post implant in his legs and feet. The deep brain stimulator was reprogrammed frequently. The hcp had taken the patient on and off his parkinson's disease medications several times. The patient experienced symptom relief but had dyskinesia at an amplitude of 2. 5 volts. When the amplitude was lowered to 2. 1 volts and the patient felt some dyskinesia but also had a return of symptoms. The field representative reported that while doing a normal impedance check, the voltage changed from 2. 1 volts to 1. 5 volts. The pulse width and rate returned to default settings (210 microseconds, 30 hertz). Patient symptoms associated with the event included left-sided dystonia, dyskinesia, difficulty breathing, talking, and a voice change. The patient kept the deep brain stimulator turned off due to the dystonia symptoms. Additional information has been requested. A follow-up report will be submitted if additional information becomes available. Please see mfg report # 3004209178-2009-01700.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1386201
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« Reply #50 on: January 17, 2014, 09:14:28 PM »

Model Number 7426
Device Problem Inappropriate shock
Event Date 02/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported, the patient experienced a shocking or jolting sensation after turning the device back on after an ekg. The patient didn't appear to have a "soft start" and used a magnet. The patient also felt a "tremor" in his leg when he was driving, but no longer had tremors.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1333324
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« Reply #51 on: January 17, 2014, 11:02:08 PM »

Model Number 7426
Device Problems High impedance; Implant, reprogramming of
Event Date 02/22/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
The patient experienced a loss of therapeutic effect. There were no falls of incidents related to the event. Impedances were checked and some of the electrodes were found to be >2000 ohms. Reprogramming was done which gave the patient some benefit, but then the patient was getting a tingling sensation down her leg. Further troubleshooting was being considered. 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=1387857
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« Reply #52 on: January 18, 2014, 04:32:26 AM »

Model Number 7428
Device Problems Extraneous radiofrequency wave transmission; Replace; Inappropriate shock; Implant, reprogramming of
Event Date 12/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient experienced worsened tremor. The deep brain stimulator was replaced due to battery depletion. At the clinic visit 1 week after device replacement, the pt experienced improved gait and slightly improved tremor control. The pulse width was increased resulting in complete tremor control to the left side of body. Mild to moderate tremor persisted in the right upper limb and occasionally right leg. The patient experienced right shoulder pain. The patient was treated with ropinirole xl and sinemet. At a clinic visit approximately 1 month later, the patient felt shocking when the device was turned on at an amplitude of 4. 0 volts. Impedances were greater than 4000 ohms on electrode combinations involving electrode #3. The tremor was well controlled at 4. 8 volts, but the patient had deteriorated, slurred speech. Therapy amplitude of 5. 7 volts controlled tremor, but caused right-sided tingling and increased slurring of speech. The pt experienced slight right-sided tingling at 4. 7 volts. At 5. 2 volts, the patient felt slight numbness to the left leg. The ropinirole caused facial dyskinesias. The device was reprogrammed to previous settings (as they were prior to generator replacement). The patient had better tremor control on the right body side on lower settings. The patient's postural stability was similar to that before increasing the settings. The patient's speech was less slurred, but slow at times. The patient ambulated with slow, small steps. The patient's condition was not able to be stabilized with reprogramming. The deep brain stimulator was replaced (b)(6) 2009. The patient was doing well with the new stimulator at the original settings. The nurse mentioned that there was.

 
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1370871
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« Reply #53 on: January 18, 2014, 04:33:41 AM »

Model Number 7426
Device Problems Repair; Implant, reprogramming of
Event Date 09/25/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the patient underwent a lead revision due to stimulation in the wrong location. The patient had also undergone a previous revision in 2008. The patient was still experiencing stimulation in the wrong location and a third revision was planned. The patient's stimulation had been felt in the legs and stomach area for about 2 years. Several device programming attempts were made but had not helped. Reference mfr report #3004209178200902683 for lead revision from 2008.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1367853
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« Reply #54 on: January 18, 2014, 04:35:50 AM »

Model Number 7426
Device Problem Loss of power
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a loss of therapeutic effect. The patient stated they were more forgetful, could not walk very well, and that balance was bad. The patient experienced double vision and reported feeling like they were in a bubble. The patient reported that the implantable neurostimulator battery was at 35% and they were having "major problems". The patient also reported problem with the patient programmer. The patient noted that the implantable neurostimulator (ins) was turning on and off without warning. The patient stated they went to the er and the implantable neurostimulator was turned back on there, then it turned off again when the pt went home. The patient's physician informed the patient that their ins had been off for two weeks but the patient stated that the patient programmer never indicated this. 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=1458868
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« Reply #55 on: January 18, 2014, 02:22:18 PM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 03/01/2009
Event Type  Injury   Patient Outcome  Other
Event Description
Literature: gervais-bernard h, xie-brustolin j, mertens p, et al. Bilateral subthalamic nucleus stimulation in advanced parkinson's disease; five year follow-up. J neurol. 2009; 256(2): 225-233. Summary: this study assessed the long-term efficacy and safety or bilateral subthalamic nucleus (stn) stimulation in patients with advanced parkinson's disease (pd). A total consecutive patients with idiopathic pd treated with bilateral stn stimulation were enrolled from 1998 to 2002. It was reported that one pt experienced lower limb phlebitis immediately postoperatively complicated by a pulmonary embolism. See manufacturer report number: 2182207200903228.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1378215
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« Reply #56 on: January 19, 2014, 11:01:35 PM »

Model Number 7426
Device Problems Replace; Implant, reprogramming of
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Other
Event Description
The pt felt stimulation in his legs and stomach for 2 years. Reprogramming was unsuccessful in resolving the issue. The hcp reported that the pt was having persistent problems with dystonia starting in the right leg and working up to the entire abdomen causing significant pain. The pt underwent revision surgery, changing the target to the globus pallidus interna. After programming the pt reported much relief and resolved dystonia. The pt was still being followed due to fluctuating symptoms. The pt outcome was reported as 'no injury. ' it was unknown if the event could be attributed to the implantable device systems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1420880
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« Reply #57 on: January 19, 2014, 11:03:13 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 06/17/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
The day prior the pt started to experience drooling, a sensation of his tongue being stuck, and tingling in his left leg. It was noted that at some point, the pt had been wrestling around with friends. X-rays were taken and no problem was detected. The device settings at the time were c+, 1-, 2-, 3-, 2. 9v, 90 pw, 185hz. The pt had not yet been evaluated by the healthcare provider. The outcome is unk. Further info is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1465678
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« Reply #58 on: January 20, 2014, 02:20:35 AM »

Model Number 7426
Device Problems Device operates differently than expected; Electromagnetic compatibility issue
Event Date 10/19/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
The pt's 2 deep brain stimulators were turned off prior to surgery. Afterward surgery, the pt's legs were freezing up. The pt was seen by their hcp, who found that one of the deep brain stimulators was turned off. It was believed to have been turned back on after surgery. Several days later, the contra lateral device was found to be off. It was believed that the device turned off on its own. The stimulator may have been affected by a microwave. Additional info has been requested. A f/u report will be submitted if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566642
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« Reply #59 on: January 20, 2014, 12:48:39 PM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1404951
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« Reply #60 on: January 20, 2014, 12:49:15 PM »

Model Number 7426
Device Problem Inappropriate shock
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a shocking/jolting sensation in their leg and eye on the left side of their body. Additional info has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1470742
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« Reply #61 on: January 20, 2014, 02:26:26 PM »

Model Number 7428
Device Problem Inappropriate shock
Event Date 07/01/2009
Event Type  Injury 
Manufacturer Narrative
 
Event Description
It was reported the patient experienced a shocking or jolting sensation randomly in her arm and leg. She additionally reported some pulling sensations that lasted for a few seconds and then goes away. The symptoms have occurred in the bathroom, at the dining table and in a restaurant. There was no correlation between the patient's positions and the symptoms. No further outcome was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1463139
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« Reply #62 on: January 20, 2014, 02:29:02 PM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1494706
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« Reply #63 on: January 20, 2014, 03:07:58 PM »

Model Number 3625
Device Problem Device or device component damaged by another device
Event Date 07/15/2009
Event Type  Malfunction 
Event Description
During a stage ii implant, there was difficulty removing the stage i lead from the ipg. The lead was protruding from the screw holes in the percutaneous extension. All of the screws were removed and the lead was found to be damaged. A new lead was placed, but the results were not the same as the previous lead. Pt was reported to have leg pain and no therapeutic benefit. The hcp is scheduled to place a new lead.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1492214
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« Reply #64 on: January 21, 2014, 12:45:40 AM »

Device Problem No Known Device Problem
Event Date 10/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: vanderhorst vg, papavassiliou e, tarsy d, shih lc. Early brain abscess: a rare complication of deep brain stimulation. Mov disord. 2009; 24(9): 1396-1397. Summary/reportable event: postoperative ct scan of the brain showed normal postsurgical changes immediately post-op. On postoperative day 3, the pt developed confusion and fever and was readmitted. There was no evidence of scalp infection at the surgical site. The pt had fluctuating inattentiveness, incoherent speech without aphasia, and left leg hyperreflexia. White blood cell count (wbc) was 15,000. Cerebrospinal fluid (csf) contained 135 wbcs, 359 rbcs, protein 51 mg/dl, glucose 98 mg/dl. Serial brain ct scans with and without contrast over the next 4 days were normal. Empirical treatment included intravenous vancomycin and meropenem. Blood and csf cultures remained negative. Repeated csf studies 4 days after readmission showed 46 wbcs, 216 rbcs, protein 71 mg/dl, and glucose 71 mg/dl. Temperature normalized but alertness continued to fluctuate. No new neurological signs developed. Brain ct scan on postoperative day 8 showed a hypodensity surrounding the right dbs electrode without ring enhancement. Brain mri on postoperative day 10 demonstrated a ring enhancing lesion with surrounding vasogenic edema in the right frontal lobe. Following mri, right frontal craniotomy showed no evidence of scalp or subgaleal infection. Reddish-gray material was found subcortically, cultures of which grew enterobacter aerogenes. The right electrode was removed. Antibiotic treatment was changed to intravenous ertapenem and was continued for 6 weeks. Mental status normalized within 2 weeks. Repeat mri at 6 weeks showed near resolution of the infection.

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« Reply #65 on: January 22, 2014, 08:37:12 AM »

Model Number 7426
Device Problem Intermittent continuity
Event Type  Malfunction 
Event Description
See also manufacturer report 3004209178201002339. The patient experienced a loss of therapeutic effect; a return of tremors. The symptoms were worse now than before. Her legs were jumping and her body was "flailing intermittently" for three hours at a time. The device had been programmed (b) (6) 2009. It was noted that about fifteen minutes prior to the first flailing episode the patient took tylenol. There was no known related accident or incident. The patient did trip and fall in her home but it was not related to a lack of therapy. Upon checking the device all three green lights were activated on the programmer. Since the third programming session on monday (b) (6) 2009 she was having "off periods" and internal tremor. Nothing had happened after the first programming following implant. After the second reprogramming she did great for two weeks. It was further stated that the stimulation was intermittent. Further information is being requested from the hcp.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1638609
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« Reply #66 on: January 23, 2014, 09:16:54 AM »

Device Problem No Known Device Problem
Event Date 03/31/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: timmermann l, pauls ka, wieland k, et al. Dystonia in neurodegeneration with brain iron accumulation: outcome of bilateral pallidal stimulation. Brain. 2010; 133(pt 3): 701-712. Summary: this article presents multi-centre retrospective study of 16 centers to gather worldwide experiences with bilateral pallidal deep brain stimulation in pts with neurodegeneration with brain iron accumulation (nbia) and bilateral pallidal deep brain stimulation (gpi-dbs). Data was collected once preoperatively and at 2-6 and 9-15 months postoperatively. It was hypothesized that gpi-dbs in pts with nbia reduces dystonia, but was overall less effective than previously reported single cases and small series that were previously published. Reportable event: one pt experienced a dystonic storm leading to spontaneous open fracture of the left femoral bone. The initial worsening of symptoms resolved after several days of stimulation and the pt subsequently experienced marked benefit in severity of dystonia.

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« Reply #67 on: January 26, 2014, 02:49:09 AM »

Model Number 37601
Device Problem Device operates differently than expected
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that there was a complaint about stimulation, tingling in the left leg. Impedances 0-3 measured 1015-2449 and 8-11 measured 1396-3258. Patient was programmed 1- and 2+ on left c+ and 9- on right. Stimulation was 100% used. Company representative did know that patient needed a revision, which was done. Patient was reported doing fine.

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« Reply #68 on: January 27, 2014, 08:14:19 AM »

Model Number 7426
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that after replacement the symptom was not improved. It was noted that now the patient was in the hospital. Additional information received reported that the patient did not clarify the device. It was noted that the patient was in the hospital for further observation and they would discuss with the hospital for programming. It was noted that the patient¿s limb and tongue stiffness was aggravated. It was noted that the left body tremble was aggravated.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528574
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« Reply #69 on: January 27, 2014, 09:19:07 AM »

Model Number 37601
Event Date 08/09/2013
Event Type  Malfunction 

Event Description
It was reported the patient had their implantable neurostimulator (ins) replaced on the day of this report and they were shaking more than they were prior to implant. The reporter stated they were concerned that the patient¿s healthcare professional let the patient go home in that condition. The reporter further stated they were unable to use the patient programmer and did not know what needed to be done. It was noted the programmer showed 75% and ok. It was further noted the programmer showed stimulation was at 3. 09v and the patient was usually at 4. 3v and 4. 6v. Follow up information received from the healthcare professional (hcp) reported that the cause of the event was unknown and that impedances were normal. No surgical interventions had occurred and it was noted that the patient did not report any symptoms to the hcp regarding the event. It was unknown if hospitalization was required for the event. It was later reported that there was a loss of therapeutic effect. The patient was shaking and confused since the new implant was put in. It was noted that the patient was waking up in the middle of the night and asking questions about surgery that had already been discussed with the patient. The patient was scheduled for back surgery on (b)(6) 2013 and would be there for a little while. Patient was implanted but was not reprogrammed till a while later due to the patient being in and out of surgery. Patient had met with the manufacturing representative once and had some reprogramming done. The display was showing a ¿call your doctor¿ icon. There was an out of regulation (oor) condition. It was noted that when using the patient programmer to make changes was when the oor icon was showing up. Patient was unable to adjust stimulation. Additional information received reported the patient¿s battery was not turned on after battery replacement. It was noted that the manufacturing representative met with the patient and turned him back on with improvement in his tremor. Device was not related to the event. The date of the new implant was (b)(6) 2013. Patient was put back on his usual settings. Patient outcome was tremor improvement. It was noted that the date of onset was after the patient¿s rotator cuff surgery in (b)(6) 2013. Diagnostics were performed on (b)(6) 2013 and very high impedances were found at contact 1 on the left electrode. The cause of the issues was unknown though he had undergone shoulder surgery in (b)(6) 2013. Interventions taken were that the plus contact was switched from 1 to 2 on (b)(6) 2013. The patient had immediate improvement in right hand tremor and was requiring less voltage. Ins was changed in (b)(6) 2013. Patient had his l4 and l5 surgery on (b)(6) 2013 and was still recovering. Patient never had physical therapy for it and was doing arm exercises with more than the recommended 2 pounds. Since rotator cuff surgery the patient¿s right hand tremor had been worse. It was noted that the adjustment had helped some. It was noted that the patient was using a walker on (b)(6) 2013. Patient had normal facial expression, blink rate, voice volume w/mild tremor. Normal speed of gesticulations. The patient had minimal postural tremor in left hand and more prominent in the right and moderate. Trunk had some mild titubation exacerbated when standing or walking because of leg pain. Patient¿s gait with the walker was normal but had a decreased stride length and looked uncomfortable. It was noted that the night prior to this report the patient had shooting pain down his legs but no longer had that. Therapeutic impedance was high on left side. Postural tremor of right hand was minimal. Patient was able to hold a mug steady with minimal tremor after programming change. Left leg pain appeared better since the surgery on the day prior to this report. It was noted that since 2010 face/head injury and punch to abdomen and (b)(6) 2010 battery change the deep brain stimulator had never provided him with as good of relief as when initially implanted. It was noted that it was somewhat better after replacement on (b)(6) 2012. Patient felt it still was not as good as when it was initially implanted in 2006. Patient had various types of trauma that could have potentially damaged the deep brain stimulator. 0 contact was still best one after exploration of left electrode contacts. In the past the patient had some motor cramping/tightness on his left face and hand when his pulse width was increased to 90. On (b)(6) 2013 reported the patient went into the healthcare professional on (b)(6) 2013 with worsening of left leg pain. Patient had chronic back pain that had started about 10 years prior to this report. The patient had been in 5 motorcycle accidents and played hockey in high school with a number of hits and concussions. Patient also had concussions in his military years in his 20¿s. The patient¿s radiation of pain was more of a muscle spasm and cramping in the posterior and anterior thigh and had some numbness in the soles of both feet. There were no bowel or bladder problems. There was some tingling in the palms of his hands. There was no weakness in the hands or legs. The patient had some right shoulder issues felt to be the rotator cuff which had not been responsive to shots. Patient had been getting injections of l3/4 and l4/5 on the left and l5/s1 on the right and had been getting them for the past year prior to this report. Gates was mildly wide based and unsteady looking but was also painful when walking or standing. Patient was unable to relax legs. The patient had a mildly decreased vibration sense in the toes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3530979
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« Reply #70 on: April 10, 2014, 09:31:03 PM »

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

 
Event Description
It was reported that after a replacement the patient had hallucinations, line of sight blurring, and limb stiffness during the night. The patient went for programming in (b)(6) 2013, but the effect did not improve. The patient called into consult how to deal with it. The following day it was reported that the patient still had hallucinations and limb stiffness.

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« Reply #71 on: May 11, 2014, 08:08:20 PM »

Model Number 37602
Event Type Injury Patient Outcome Other
Event Description
It was reported there was a shocking or jolting sensation. It was noted the patient felt ¿paralyzed in their leg¿ the day prior to report. It was noted they felt ¿paralyzed in their arm and shocking¿ since the implant. It was noted the patient had fallen on (b)(6) 2013. It was stated they had fallen and broken their hip. It was noted the patient had not done well since the fall. It was noted the paralyzed feeling in their leg had not gone away. It was stated their arm would go paralyzed for 8 seconds and then it would stop. It was noted the patient had seen their doctor the week prior to report and no adjustments or changes were made to the dbs settings. It was noted they had requested to not have the dbs raised because it would cause a shocking sensation and it would paralyze them.
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387-40, lot# l54554, implanted: (b)(6) 1998, product type: lead. Product id: 7495-25, serial# (b)(4), implanted: (b)(6) 1998, product type: extension. (b)(4).

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« Reply #72 on: May 11, 2014, 08:10:13 PM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant medical products: product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(4) 2008, product type: lead. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2008, product type: lead. (b)(4).
Event Description
It was reported that the physician¿s assistant (pa) called the reporter stating therapy impedance was high. The reporter did not have the settings or all of the impedance readings. The reporter stated that this may have been the first follow-up since implant and the patient was in for a suture check. The patient also complained of shocking down her jaw and leg that occurred every four to five minutes. The shocking would go away when the device was turned off. Palpation did not show anything and the ¿left was fine. ¿ the following day it was reported that the patient experienced shocking and a feeling of parasthesias in the left face, neck, tongue, cheek, and even in her leg that occurred every four to five minutes. It was also noted that during a clinician programmer programming session when the programmer head was pressed up against the implantable neurostimulator (ins) pocket she ¿felt a little something at the pocket. ¿ the patient was seen by the pa the day prior to the report and her impedances were checked. They looked to be within normal range, but it was noted that the clinician programmer indicated the therapy impedance was high. The reporter stopped by the clinic during the session and also got a high therapy impedance. They decreased the patient¿s voltage from 3 volts to 2. 8 volts and all of her shocking and parasthesias went away. The sensation that occurred when the programmer head touched the pocket site also went away. The patient had had good therapy since the most recent ins replacement and continued to get therapy after voltage was changed. They planned to keep an eye on the patient going forward for any changes. The patient was scheduled to be seen in (b)(6) 2014. Three days later it was reported that the patient still felt the shocking sensation, so the doctor was making arrangements to see her again the week of the report. Nine days later it was reported that the patient was to be seen again on (b)(6) 2014 for further investigation. The patient was tentatively scheduled for an extension revision. Additional information was requested, but was not available as of the date of this report.

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« Reply #73 on: May 11, 2014, 08:11:30 PM »

Model Number 37603
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported the patient had a spasm on the left side implant. It was noted the patient had a lead revision due to capsular side effects. It was noted the patient status at the time of report was alive with no injury. It was further reported the patient outcome was unknown. Additional information received reported the cause of the event was a malpositioned lead. It was noted there were no abnormal impedance measurements. It was noted the patient had leg stiffness with the stimulation. It was stated after the lead was revised the patient had better tremor control and leg stiffness.
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v878980, implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

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« Reply #74 on: June 07, 2014, 10:17:50 AM »

Model Number 37601
Event Date 04/15/2014
Event Type Injury Patient Outcome Hospitalization,Other
Event Description
It was reported that after the surgery the patient had been in a state of a coma. It was noted that after the patient regained consciousness the activities of the right lower limb was not flexible. It was noted that there was no patient death. Additional information received reported that the no diagnostics were performed, no malfunctions were seen, and no interventions were taken or planned. It was noted that the patient lived in the hospital now.

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« Reply #75 on: June 07, 2014, 10:18:25 AM »

Model Number 37602
Event Date 05/07/2014
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported the patient had complained of being shocked in the chest from the device and they had a pain that would run down the left side of their body and down their left leg. It was noted the device was explanted on the day of report. It was stated a different product was used and the issue was resolved. It was noted the patient status at the time of report was alive with no injury. It was noted the patient had a burning sensation at the device pocket at the right side implant.

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« Reply #76 on: June 07, 2014, 10:19:41 AM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported on (b)(6) 2014 that there were some out of range impedances on the right side. The measurement of unipolar 4 was 6,600 ohms, 5 was 2,400, and 6 was 2,100. The impedances were not tested at a higher setting. The patient needed a mri for possible neurological issues. The patient was seen in september or october by his healthcare provider (hcp) and at the time he was getting great therapeutic benefit. Three to five days later the patient started to have vision lapses, which lasted a few seconds, and occurred every few hours. The patient also started to experience a loss of muscle tone in his legs after visiting the hcp, describing it as ¿giving out. ¿ this occurred a few times a day. The patient was seen by other physicians and they ruled out seizures. In december the patient¿s implantable neurostimulator (ins) was turned off completely and remained off at the time of the report. The patient still had some vision differences and his legs still gave out, but he was not falling as often. The reporter noted that the patient would be having a battery replacement due to it being near end of life (eol) from normal depletion. Five days later it was reported that the patient was doing fine and he was scheduled for a battery replacement ¿in a few weeks. ¿ the following day it was reported that there were out of range impedances on the left side. However, it was noted that typical numbering suggested the impedances were for the right side. Thus, it was unclear which side had out of range impedances.

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« Reply #77 on: July 05, 2014, 12:11:01 AM »

Model Number 7426
Event Type Injury Patient Outcome Required Intervention,Hospitalization Manufacturer Narrative
Concomitant medical products: product id 3387-28, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2014, product type: lead. (b)(4).
Event Description
It was reported that 18 months prior to report, the impedance values of the patient¿s #0 and #2 electrodes suddenly decreased. It was further reported that this ¿resulted in high-power stimulation and the patient presented with symptoms of internal capsule stimulation. ¿ it was stated the patient¿s physician considered the ¿possibility of a lead problem¿ and it was decided to replace the patient¿s leads on (b)(6) 2014. It was reported that following the replacement of the lead, the patient¿s ¿impedance values had not changed at all. ¿ it was stated ¿the problem was not attributable to the lead¿ and ¿the physician did not know what might be a possible cause. ¿ additional information stated that when stimulation was performed on (b)(6) 2013 there ¿were fluctuations in the electric current value due to fluctuations in impedance. ¿ it was reported that when impedances were checked on (b)(6) 2013 ¿there were no problems with the left electrode¿ and that the right electrode¿s #0 and #2 had ¿low¿ impedances. Impedance records indicate the ¿low¿ values for contacts #0 and #2 were 346 ohms and 479 ohms respectively. It was stated the patient¿s ¿neck was still in pain¿ and that it was ¿difficult to face right. ¿ it was reported that ¿tension in the right dominant sternocleidomastoid (scm) was the most noticeable¿ and that it was also noticeable in the patient¿s right trapezius muscle. It was noted the patient had ¿botulinus administered on (b)(6) 2013 and that ¿it was difficult to control the patient¿s symptoms in their neck region, so botulinus was used concurrently. ¿ it was reported that ¿dystonia was not triggered through stimulation in the left finger like it was in the past. ¿ it was stated the patient had been previously hospitalized at a neurological hospital in (b)(6) 2012. It was further reported that impedance testing performed on (b)(6) 2014 found ¿low¿ impedances on electrodes #0 and #2 of 259 ohms and 356 ohms respectively ¿ both measured at 2. 5 volts. It was again noted these impedances were ¿too low. ¿ while performing stimulation testing it was reported the patient experienced their left hand being ¿heavy. ¿ it was stated the patient could not fully extend their fourth or fifth fingers at times during the test. Eventually it was noted the patient could extend their fourth finger ¿if done consciously. ¿ it was additionally reported that a surgery was performed on (b)(6) 2014 ¿to shift the dbs (deep brain stimulation) electrode on both sides. ¿ it was stated this was performed because ¿there was a problem with the electrode placement position itself¿ and ¿there was a concern about whether the impedance was low due to the dbs electrode. ¿ it was further stated there ¿seemed like there was a problem with the dbs electrode itself (disconnection?). ¿ it was reported that after the surgery to shift the electrodes, the impedances in the right electrodes #0 and #2 were ¿still low. ¿ the ¿low¿ therapeutic impedance values when measured at 3 volts were found to be 269 ohms and 374 ohms for electrodes #0 and #2 respectively. It was stated that ¿when the electric current was applied¿ the patient complained of ¿tingling sensations in the implantable neurostimulator (ins) region. ¿ it was further stated the patient reported the ¿ins was painful¿ and the ¿ins was tingling. ¿ it was reported it was ¿slightly difficult to extend [their] left fingers¿ and ¿slightly difficulty to bend [their] right fingers¿ during a stimulation test. It was additionally reported that during the stimulation test the patient¿s right upper limb and lower left limb were ¿slightly heavy¿ and the right bottom half of the patient¿s body ¿felt tingly and fuzzy. ¿ it was stated the patient¿s shoulder also felt ¿strained. ¿ impedance testing performed on (b)(6) 2014 indicated the right electrodes #0 and #2 had impedances of 294 ohms and 432 ohms respectively. Impedance testing also indicated the right bipolar electrode pair 1-3 had an impedance value ¿>2000¿ ohms. It was noted that electrodes #0 and #2 ¿were both five years old. ¿ additional information reported ¿electrode replacement surgery was performed, however, the resistance value was low and did not change. ¿ it was stated there was ¿possibly a problem with the electrode and there was a problem with the indwelling position of the lead as well. ¿ it was noted that on (b)(6) 2014 a lead was ¿extracted¿ and would be collected at a later date for analysis. It was additionally noted that ¿since the low resistance continues even after changing the ins and lead, the cause of the low resistance could be from the extension part. ¿ it was noted the patient was admitted to the hospital for ¿recovery¿ following their lead replacement procedure. Additional information stated ¿stinging sensations persisted¿ after the lead replacement was completed. Additional information stated the patient ¿had not had effective therapy¿ and the ¿cause was not determined¿ as of 17 days after initial report. A supplemental report will be filed if additional information is received.

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« Reply #78 on: July 05, 2014, 12:11:39 AM »

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

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« Reply #79 on: August 10, 2014, 06:24:10 AM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported that the patient had a loss of therapeutic effect. The reporter wanted assistance in evaluating system integrity and because the implantable neurostimulator (ins) was shutting off. The patient had developed some worsening symptoms in her right leg over the past two weeks. The patient saw the clinician in office on wednesday and was switched to group a. The patient left feeling good, but then felt stimulation was turned off and had worsening symptoms with breakthrough tremor and decline of leg usage. The leg issues resulted in slowness of movement. The patient checked the ins with her programmer and saw stimulation was off. It was not known what happened with therapy when the patient turned back on. The patient was then seen on friday and found that she had switched to group b. The patient was reprogrammed back to group a, but ¿six hours later she felt like it shorted out on her. ¿ the device usage seen on friday showed that one day group a ¿had dashes in the middle and said aaa. ¿ the patient noted that she did not s witch back and forth often and was mostly in group b. When in group a the patient was more dyskinetic and had some tremor break out. It was also noted that since replacement the patient had not had the same therapy as before. The reporter then saw the patient on the day of the report and took impedances in different positions. While looking up the patient had a low impedance of 60 ohms on electrode combination 2 and 3. The patient also had high impedances over 4,000 ohms while looking down, right, left, and a normal head position on electrode combination 0 and 3. It was also noticed that the battery voltage was 2. 96 and dropped to 2. 7 during no therapy and then back up to 2. 95 again. Two days later it was reported that the patient appeared to be experiencing a short between contacts 2 and 3. The issue was device related and it was unknown how much therapeutic effect was experienced by the patient. The doctor performed x-rays looking for signs of damage. The reporter was able to recreate the low impedance when the patient turned to the right. At the time of the report the plan was to replace the extensions on (b)(6) 2104.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v069269, implanted: (b)(6) 2008, product type lead; product id 3387s-40, lot # v069269, implanted: (b)(6) 2008, product type lead; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2008, product type extension; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2008, product type extension; product id 37642, serial # (b)(4), product type programmer, patient. (b)(4).

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« Reply #80 on: September 06, 2014, 12:51:26 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Concomitant medical products: product id: 3387, lot# unknown, product type: lead. (b)(4).
Event Description
Sriram, a. , foote, k. D. , oyama, g. , kwak, j. , zeilman, p. R. , okun, m. S. Brittle dyskinesia following stn but not gpi deep brain stimulation. Tremor and other hyperkinetic movements (new york, n. Y. ). 2014;4:242. Doi: 10. 7916/d8ks6ppr summary: the aim was to describe the prevalence and characteristics of difficult to manage dyskinesia associated with subthalamic nucleus (stn) deep brain stimulation (dbs). A small subset of stn dbs patients experience troublesome dyskinesia despite optimal programming and medication adjustments. This group of patients has been referred to by some practitioners as brittle stn dbs-induced dyskinesia, drawing on comparisons with brittle diabetics experiencing severe blood sugar regulation issues and on a single description by mclellan in 1982. We sought to describe, and also to investigate how often the ¿¿brittle¿¿ phenomenon occurs in a relatively large dbs practice. An institutional review board-approved patient database was reviewed, and all stn and globus pallidus internus (gpi) dbs patients who had surgery at the university of florida from july 2002 to july 2012 were extracted for analysis. There were 179 total stn dbs patients and, of those, four stn dbs (2. 2%) cases were identified as having dyskinesia that could not be managed without the induction of an ¿¿off state,¿¿ or by the precipitation of a severe dyskinesia despite vigorous stimulation and medication adjustments. Of 75 gpi dbs cases reviewed, none (0%) was identified as having brittle dyskinesia. One stn dbs patient was successfully rescued by bilateral gpi dbs. Understanding the potential risk factors for postoperative troublesome and brittle dyskinesia may have an impact on the initial surgical target selection (stn vs. Gpi) in dbs therapy. Rescue gpi dbs therapy may be a viable treatment option, though more cases will be required to verify this observation. Reported event: one (b)(6) male patient experienced right upper extremity and right lower extremity dyskinesia at both the 1 and the 2 contacts on the deep brain stimulation (dbs) lead following left-sided subthalamic nucleus (stn) dbs implant. It was noted that the 1 and 2 dbs lead contacts corresponded to the best therapeutic benefit during programming sessions. The reporter stated that multiple programming strategies were employed, including attempts at slow stimulation titrations, and the use of a more dorsal dbs contact site. Reportedly, the dyskinesia only abated when the dbs was turned off. It was noted that attempts were made to commensurately decrease carbidopa/levodopa dosage in combination with stimulation changes, but this reportedly worsened the patient¿s off state, though at low medication dosages dyskinesia abated. The reporter stated that the patient experienced a similar clinical scenario when the right stn dbs was added. Reportedly, at settings that improved his freezing of gait, the patient had bothersome left lower extremity dyskinesia. It was noted that many other attempted settings failed to capture his gait freezing and the off symptoms. The reporter stated that the patient underwent rescue bilateral staged globus pallidus internus (gpi) dbs in a single operative sitting, and following programming, the dyskinesia completely abated, and the patient was able to maintain a smooth on medication state. The source literature included the following device specifics: lead model 3387 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=3976613
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« Reply #81 on: September 06, 2014, 01:51:07 AM »

Model Number 37601
Event Type Injury Patient Outcome Hospitalization
Event Description
Additional information received reported that there was a 50% or greater symptom reduction. The cause of the event was not determined, but it was not device related and did not require reprogramming. The patient was hospitalized due to disorientation and confusion. The patient was in a group home setting as well. No interventions or action were taken and the patient outcome was unknown.
Manufacturer Narrative
Concomitant medical products: product id 37601, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3389s-40, lot# v333543, implanted: (b)(6) 2009, product type: lead; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389-40, lot# l75963, implanted: (b)(6) 2000, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 7495-25, serial# (b)(4), implanted: (b)(6) 2000, product type: extension. (b)(4).
Event Description
An emergency room (er) doctor reported that the patient had a sudden loss of therapeutic effect as it happened within the past one or two days. The patient presented to the er on the day of the report with decreased alertness and tonic-clonic tremors in his arms and legs. The symptoms were worse on the left side than the right. The patient¿s wife felt like this was a return to baseline symptoms for him. It was requested that a manufacturer representative come check the patient¿s system as there was no patient programmer available. No patient intervention or outcome was reported, so additional information was requested. If additional information is received a supplemental report will be sent.
Manufacturer Narrative
(b)(4).

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« Reply #82 on: October 13, 2014, 12:37:14 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v230715, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. (b)(4).

Event Description
It was reported that the patient had a stimulator in her chest for essential tremors with parkinson¿s. There was a loss of therapeutic effect. There was a sudden onset of symptoms. Onset was following the patient¿s neighbor had started up a lawn mower while the patient was sitting outside reading a paper and it was so loud and the patient had not known until it was too late, the damage had already been done. The patient had not gone anywhere when this had occurred on the day prior to the date of this report, she had not even left the house. Patient symptoms included tingles down her arm, legs and face, a dull ache in her left ear that she had after surgery and it was back the time of this report and hearing issues. The patient was right handed and the implant was in her left chest. The patient¿s right hand was usually very steady, but was shaking at the time of this report. The patient was unable to hold a toothbrush, fork, a pen or anything. The patient checked her device and it said on with a black triangle and the patient checked again and it said on and ok. The patient had checked her device twice on the day prior to the date of this report to make sure she was on and it was. There had been no problems with the patient¿s previous stimulator, which the patient had for 5 years before having it replaced and the current stimulator had been nothing, but problems/issues. The patient had issues with it since (b)(6) 2014 when it was implanted. The patient looked as though she had a pack of cigarettes sticking out of her chest and the wires looked like they were sticking out of her neck and had not before. The incision was healed and there was no tenderness or redness over the scar. Prior to (b)(6) 2014, the patient had been getting control of her symptoms, but it had been sending her into circles, which meant she was dizzy and had shakes in her right and left hand and pin pricks all over her legs and arms. A healthcare professional had instructed her to turn stimulation on and leave it on and not to turn stimulation off at night in order to prevent side effect. The patient would experience the ¿circles¿ when she had the device off and turned it back on. No interventions or outcome were provided regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

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« Reply #83 on: October 13, 2014, 01:39:56 AM »

Model Number 37603
Event Date 08/15/2014
Event Type Malfunction
Event Description
It was reported they were unable to adjust stimulation. They questioned whether the stimulation was on or not. The device was powered off. Troubleshooting occurred and using the on/off controls they were able to resolve the issue with checking to see if the patient¿s stimulation was on or off. The patient¿s stimulation was turned back on for therapeutic use. The symptoms had a sudden onset. The patient was at their health care professional¿s office 9 days prior to report for a programming adjustment and they checked their settings the day prior to report with their patient programmer. The patient had noticed a difference in stimulation on the morning of report. The patient had freezing of their left leg and foot. They had been having problems with the therapy for the last week. They had issues and so they were seen by the manufacturer representative in june and the patient went at the end of (b)(6) to get the settings changed and something ¿wasn¿t right¿ so they went back in the week prior to report for another programming adjustment. The last programming adjustment helped with their prior symptoms ¿for the most part. ¿ the patient felt okay. The stimulation was noted to be back on.

Manufacturer Narrative
Concomitant medical products: product id 37642, serial# unknown, product type: programmer, patient; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3389s-40, lot# v846964, implanted: (b)(6) 2012, product type: lead. (b)(4).

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« Reply #84 on: November 07, 2014, 11:02:36 PM »

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

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

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« Reply #85 on: November 08, 2014, 01:48:07 AM »

Model Number 7428
Event Type Injury
Event Description
It was reported that the patient experienced infection due to skin breakdown at the lead site in (b)(6) 2013, three years after implant. There were no other signs or symptoms of infection. The right lead was cut and explanted. The hcp ¿got the lead stopped working¿ and ¿wrapped it in the plastic tube. ¿ the infection resolved. On (b)(6), the patient¿s limbs became rigid and the patient suspected the left lead had stopped working. It was found that the implantable neurostimulator (ins) was off. The ins was turned on and reprogramming was performed. The patient was ¿good¿ after reprogramming.

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, serial# unknown, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4182435
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« Reply #86 on: November 08, 2014, 03:15:31 AM »

Model Number 37751
Event Date 09/22/2014
Event Type Other
Event Description
I had a metronic neurostimulator implanted in (b)(6) 2014 then my legs became weak, joints feel like i have arthritis, had chronic low grade temp, burning at battery and pain every where leads, battery and paddle implanted, had so much weakness in my legs that i was having trouble walking and had to have it removed at another facility in (b)(6) 2014 and still having arthritic symptoms and back pain.

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« Reply #87 on: November 08, 2014, 08:30:18 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant product: product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator. (b)(4).

Event Description
It was reported that around (b)(6) 2013, the patient¿s symptoms had gotten worse, they had tremor on their right side, and their limbs were distorted. After the implantable neurostimulator (ins) was implanted on the right side the patient¿s symptoms on their left side were controlled well. The patient was then implanted with an ins on their left side to control the symptoms on the patient¿s right side. On the same day the patient¿s healthcare professional adjusted the target position of the right ins. Following surgery the patient felt the left ins was heavier than the right ins, but the symptoms were controlled well. On (b)(6) 2014, the patient¿s limbs were trembling, their joints were distorted and their symptoms had gotten worse. The patient was reprogrammed on (b)(6) 2014, but their symptoms did not improve. Follow up with a manufacturing representative indicated that the cause of the event was not determined and it was unknown if intervention was done or if the patient was receiving effective therapy. No interventions or outcome were reported regarding this event. Additional information could not be obtained. Should additional information be received the event will be updated. Refer to manufacturer report #3004209178-2014-18342.

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« Reply #88 on: January 10, 2015, 04:03:36 AM »

Model Number 7428
Event Date 11/18/2014
Event Type Injury
Event Description
It was reported the patient was hospitalized on (b)(6) 2014 for walking difficulty. By (b)(6) 2014, the patient¿s symptoms of walking difficulty and leg weakness had not improved after taking medicine every day. The patient suspected the implantable neurostimulator (ins) was turned off accidently before they took their medicine. On (b)(6) 2014, the patient was reprogrammed and the ins was not turned off. The patient¿s healthcare professional did increase the voltage by 0. 1v and their symptoms got much better. The cause of event was not determined and the patient was doing well at the time of this report.

Manufacturer Narrative
(b)(4).

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« Reply #89 on: January 10, 2015, 05:36:42 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient¿s ¿effect was stable¿ and their ¿programmer could work normally¿ following the replacement of their implantable neurostimulator (ins) on 2014-(b)(6). However, in 2014-(b)(6) the patient¿s programmer reportedly ¿couldn¿t work. ¿ furthermore, ¿the patient¿s limbs were trembling when the device was turned on. ¿ the patient¿s physician reportedly ¿judged the cause as lead disconnection. ¿ the patient¿s lead was replaced as a result. Following the lead replacement, ¿the patient¿s symptom got better and the programmer could work. ¿ it was noted the ¿patient didn¿t fall down¿ at that time. A supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant: product id 3389-40, lot# 0204990374, implanted: 2011-(b)(6), product type lead. (b)(4). Device evaluation: analysis of the lead found ¿all four conductors were broken 3. 3 cm from the proximal end of the lead. There was also breached esc (environmental stress cracking) 8. 8 and 9. 6 cm from the distal end of the lead. ¿ it was also noted that ¿all circuits were open¿ during functional testing.

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« Reply #90 on: January 10, 2015, 11:33:57 AM »

Model Number 7428
Event Type Injury
Event Description
It was reported that ¿efficiency was not good¿ after the device was implanted; the patient still had dyskinesia symptoms. Every time seasons changed, the patient experienced pain in their head and chest area where the implant was. Due to the ¿poor efficiency¿, the patient¿s mood was ¿not stable¿ and she wanted to commit suicide in (b)(6). Reprogramming was attempted then, but the dyskinesia didn¿t get better, and in (b)(6), got worse. Reprogramming was again attempted early november and the dyskinesia got better but the patient¿s ¿active was stiff¿ due to the changed stimulation mode. Three days later, the patient¿s legs felt weak, and she additionally felt cold and sick. Sinemet and madopar were taken, and the symptoms got better. Four days after that, the patient went for a ¿blood check¿ and the healthcare provider indicated the patient ¿didn¿t get cold¿. Subsequently, the patient¿s whole body felt weak again, and she felt cold and sick. Reprogramming was again attempted approximately a week later, and after increasing ¿the parameter¿, "the symptom" was controlled. The patient was doing well.

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« Reply #91 on: February 07, 2015, 06:57:56 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37642, serial # (b)(4), product type programmer, patient; product id 3387-40, lot # j0437239v, implanted: (b)(6) 2004, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2004, product type extension; product id 3387-40, lot # j0437239v, implanted: (b)(6) 2004, product type lead; product id 37601, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension. (b)(4).

Event Description
It was reported the patient had their annual checkup last friday and they brought their patient programmer with them because they could not get the programmer to do anything. The patient changed the batteries in the programmer and they could still not get it to do anything. The patient tried alkaline batteries, but the issue did not resolve. The patient¿s healthcare professional (hcp) checked the programmer and they said it was ¿kaput. ¿ the problem with the programmer started recently. The patient¿s legs started hurting with continual pain about two weeks prior to this report and when they tried using the programmer to increase stimulation to cover the pain, they were not able to since the programmer would not power on. The patient stated they had deep brain stimulation for pain due to multiple back surgeries. The patient¿s pain was controlled to some extent and stimulation covered about 50 percent of their pain. The rest of the patient¿s pain was controlled with oxycontin. The patient¿s left implant controls their endorphins and th eir right implant was for pain. The hcp stated the implantable neurostimulator (ins) on the left side was dead and that ins had been implanted for ten years. The patient stated their hcp was concerned about the left ins that controls the patient¿s endorphins because that ins was dead. Upon device return, analysis of the patient programmer found the telemetry board was corroded and the antenna jack was resoldered as a preventative measure, c300. Additional information received reported the stimulator on the left side that controlled the endorphins had never been replaced. In november prior to the date of this report when the patient had last visited his healthcare professional he was told that the left side stimulator was dead. The patient had been scheduled to have both sides replaced in (b)(6) 2015. It was noted that from what the patient was able to gather they had planned to only replace the right side stimulator for pain which lead him to believe that the stimulator for the endorphins had not been functional so it would not be replaced.

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« Reply #92 on: February 07, 2015, 06:58:43 AM »

Model Number 37601
Event Date 12/18/2014
Event Type Malfunction
Event Description
It was reported the patient saw their healthcare professional (hcp) for an adjustment the day prior to this report and they could hardly walk after. The patient stated the hcp was trying to adjust them, but they made them worse and they were walking like they were drunk. The hcp adjusted the patient back to the original settings, but the patient was still messed up. The patient wanted to lower both sides, but they could not. Every time the patient¿s setting went up they felt pins and needles running down their legs. The pins and needles had been going on since implant a month or so prior to this report. The patient¿s left side was at 1. 50v and the right side was 1. 50v. The patient stated one of them went down to 1. 10v, but then it popped back up and they could not lower it. The patient wanted to lower the settings on both sides so the feeling would go away. A lower limit screen was reached when the patient tried to lower the left side. The patient thought they were able to lower the left side before. The patient was able to lower the right side to 1. 10v. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 7 482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3387s-40, lot# v281324, implanted: (b)(6) 2009, product type: lead; product id 3387s-40, lot# v268107, implanted: (b)(6) 2009, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 64002, lot# n450589, implanted: (b)(6) 2014, product type: adapter. (b)(4).

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« Reply #93 on: February 07, 2015, 12:03:33 PM »

Model Number 37602
Event Type Malfunction
Event Description
It was reported the patient had a shocking or jolting sensation. Since the patient¿s implantable neurostimulator (ins) was replaced in (b)(6) 2013 the patient had experienced significant shocks every time the ins was turned off with the patient programmer or during reprogramming. The healthcare professional (hcp) observed the shocks the day prior to this report when they were reprogramming the patient. The hcp stated the shocks were severe and lasted less than a couple seconds. The shocks were more severe when the ins was turned on. The patient felt the shocks on the left side of their face, arm, and leg. The hdp did not decrease stimulation before turn the ins off because it happened during reprogramming when they were changing the electrode configuration and the amplitude automatically dropped down to zero. The patient felt the shocks when the stimulation was at 0. 0v. The hcp stated that impedances may have been a little on the low side around 700-800 ohms, but nothing out of range. The patient was programmed at c+, 1- at 3. 5v, pulse width of 90, and a rate of 130 hz. The patient had previously been programmed at 4. 0v and a pulse width of 90. The ins was not programmed using interleaving and the ins was in voltage mode. Bipolar programming had not been tried. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id 3387s-40, lot# v311441, implanted: (b)(6) 2010, product type: lead; product id 37642, serial# (b)(4), implanted: (b)(6) 2011, product type: programmer, patient; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

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« Reply #94 on: February 07, 2015, 12:04:10 PM »

Model Number 37601
Event Type Malfunction
Event Description
It was reported that the patient had the device implanted on (b)(6) 2014 for parkinson¿s and the patient believed the right side was disconnected. The patient had a return of tremors on the left side, he could not walk and kept falling. It was noted that when the patient was taking a shower he had rubbed his head kind of hard and scratched it a little and when he pressed down on his head he could feel tingling in his feet and legs on the left side. This had all begun 3-4 days prior to the date of this report. The patient had called and scheduled an appointment for (b)(6) 2014. No intervention or outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

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

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« Reply #95 on: March 07, 2015, 04:50:46 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# va0mlnr, implanted: (b)(6) 2014, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387s-40, lot# va0mqlu, implanted: (b)(6) 2014, product type: lead. (b)(4).

Event Description
It was reported that after implant the patient had the flu, a bladder infection, and then trouble breathing. The deep brain stimulation was not helping as the patient expected and they never had therapeutic effect. The patient stated they were in worse shape now than before the surgery. The patient had concerns with freezing and trouble walking. About two weeks prior to this report they went down to their knees due to trouble walking. The patient stated that they saw somewhere that deep brain stimulation was not for freezing or walking. Since implant the patient had developed bladder control issues at night. The patient has macular degeneration and since implant their eye healthcare professional (hcp) told them they had developed ¿a jelly type thing behind their eye that was putting pressure on their eyes. ¿ the eye hcp was not sure if it was related to deep brain stimulation or not. After the stage one and two implants the patient had a stent in the left leg implanted and a vein closed in their right leg. Reprogramming had been done twice and the patient¿s last appointment with their hcp was on (b)(6) 2015. The patient¿s next appointment was scheduled for (b)(6) 2015. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4480167
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« Reply #96 on: March 07, 2015, 04:51:33 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that during the call the patient had seemed confused. The patient and his wife were having a ¿rough time¿ and he had device turned on the morning of the date of this report for the first time. The patient had come into possession of the controller and read though the handbook. The patient was having some delirium in the midst of dyskinesia episode. Several implantable neurostimulator (ins) checks were done and showed the ins was fully charged/brand new and should provide a good service life. The patient was in agony, his pain level had gone up since the unit had been installed. The patient had pain in his right and left leg which had started about a year prior to the date of this report. The patient had parkinson¿s but had not had a tremor, he had a tightening of the muscles in his thighs and that caused pain and it had been developing over a couple of years and that was the reason for the deep brain stimulator system to control his pain. The patient thought his wife was causing his pain but the only thing she could do was shut the device off. The patient had left the healthcare professionals at noon on the date of this report and they were thrilled because his pain was better then he had taken his noon dose of sinemet and started having extreme dyskinesia where he had kind of gone into an altered state and his pain was unbearable, it was impossible to really know. The patient was due for his 3 pm sinemet dose, the patient had expressed concern for double dose and the patient¿s wife confirmed the healthcare professional had given them instructions to continue regular medication dose. They were going to discuss the first 24 hours on the day following the date of this report with their healthcare professional and they would decide if the patient can cut back on medications or leave them as is for a while. It was stated that ¿yes you are having more effect because your medications are the same and now you have the stimulation on top of that causing you to have dyskinesia worse than usual. ¿ no outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# va0nesh, implanted: (b)(6) 2014, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4503250
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« Reply #97 on: March 07, 2015, 04:52:22 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient had the following symptoms: altered mental status, burning sensation, change in gait, difficulty walking, leg dragging and swelling. The patient¿s stimulation had to be turned up pretty high in order to control his tremor. Sometimes when it was so high he had a burning sensation in his face. When stimulation was turned off he still felt the burning sensation and he wanted to know if this was normal and if it was possible that it could cause permanent damage. When stimulation was turned off it took a couple of days for the burning to stop. The burning in the patient¿s face had started sometime in early to mid-(b)(6) 2014. There was a spot right about his lip that took longer to have the burning go away and sometimes it would take about a month before the burning stopped. The patient had two leads, one on the right and one on the left that were both connected to an one implantable neurostimulator (ins) which was in his left chest. The patient was told that in order to help with the progressive tremor and the burning in his face they would need to implant a 3rd lead and another ins in the other side chest and the patient was inquiring if this was normal. The patient¿s tremor was progressing and he was able to tell weekly because the tremor was moving and increasing. The patient¿s left hand was getting worse and he gait was also changing. Sometimes the patient had voice trouble, with tremor in his voice and sporadically he had uncontrollable tremor with his head and eye lids. The stimulation had worked at controlling his symptoms for a few months but the tremor had been gradually increasing so the patient was unsure if it was a stimulation issue or a symptom issue. Amplitude was set at 1. 3 volts on the right side of the brain. The patient had a fall a couple of weeks prior to the date of this report, the patient stated that he had many ¿almost falls¿ but the last one was a couple of weeks prior to the date of this report. It was noted that it had been a nightmare since day one. The patient stated that when the leads were put in the brain he had an edema of the brain and they were not sure what the swelling was from but the patient had brain damage from the swelling. After the implant they had brain swelling. The patient had blood clots from being down for so long. Also, the patient was unable to use the right side of his body for a few days after the surgery. The patient zoned out, the nurse would bring the patient into a dark room and he would not be able to figure out what he was supposed to do until he was directed to turn on the light. The patient had stated that it was like he knew what to do but would get stuck in between what he should do and how to do it. On occasion he would have to use the left hand to move the right hand and also he would want to use his right hand but he wouldn¿t know how to use it. The patient was able to walk normal but sometimes his leg would drag. Most of the time it was the left leg that would drag but it would also be the right as well but the left was worse. Following implant of the leads the patient was already having problems before he even got home. It was so bad that his wife brought him to the emergency room. It was noted that while at the emergency room the patient was so thirsty, he got up and walked over to the faucet; he could hear the water gurgling in the pipes but forgot to turn on the water so he was trying to suck the water out of the faucet. The patient would drift in and out of reality. The patient was still having concerns with their device or therapy but was working with their healthcare professional or manufacturing representative. The patient had an appointment scheduled but the date was illegible. No outcome or intervention was reported. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. 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: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4515835
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« Reply #98 on: April 19, 2015, 02:29:48 AM »

Model Number NEU_UNKNOWN_LEAD
Event Date 03/02/2015
Event Type Injury
Event Description
It was reported there was a subdural hygroma without mass effect. The patient had bilateral leads placed and the stimulator was scheduled to be placed later in (b)(6) 2015. The patient experienced a headache with bilateral leg weakness. The patient was observed in emergency department overnight. A ct scan with contrast revealed a small amount of extra axial fluid of simple density overlying the vertex. It was likely a subdural hygroma without mass effect. The etiology was the surgery/anesthesia and was unlikely related to the device or therapy and possibly related to the implant procedure. The event resulted in in-patient hospitalization. Refer to manufacturer report # 3007566237-2015-00790 the patient is implanted with bilateral leads.

Manufacturer Narrative
Concomitant: product id neu_unknown_lead, implanted: 2015-(b)(6), product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4638119
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« Reply #99 on: April 19, 2015, 02:30:26 AM »

Model Number 37601
Event Date 01/24/2014
Event Type Injury
Manufacturer Narrative
Concomitant: product id neu_unknown_lead, product type lead. (b)(4).

Event Description
It was reported that the patient experienced shaking in the hands, rigidity in the legs, and a lisp after an implantable neurostimulator (ins) replacement on 2014-(b)(6). In (b)(6) 2014, the patient took mri films to a new physician who indicated the target location of the lead was ¿not accurate¿ and a second surgery was recommended. The patient¿s implanting physician believed there wasn¿t a problem with the target position. The patient wants to have a second surgery but no date for the surgery had been reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4637974
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« Reply #100 on: May 09, 2015, 02:07:58 AM »

Model Number 37601
Event Date 10/01/2014
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3387, lot# unknown, product type: lead; product id 3387, lot# unknown, product type: lead; product id neu_unknown_ext, serial# unknown, product type: extension; product id neu_unknown_ext, serial# unknown, product type: extension. (b)(4).

Event Description
It was reported that the patient experienced myoclonic jerks of arms and legs. Corrective actions included medication added, discontinued or dose changed. Depakote was started after lab work was reviewed on (b)(6) 2014. The event was not resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4662492
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« Reply #101 on: June 08, 2015, 06:02:11 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the essential tremor patient experienced ¿shocking sensations and paresthesias¿ in his left arm, torso, and leg with the sensations ¿not limited to a specific location. ¿ the patient reportedly ¿could induce the sensation when pressing onto the implantable neurostimulator (ins),¿ however sometimes the shocking sensations would also occur ¿without any external influence. ¿ the patient additionally experienced ¿intermittent stimulation,¿ whereby the patient¿s tremors ¿reoccurred regularly, as if the ins was turned off. ¿ it was stated the patient experienced ¿less than 50% therapy relief¿ on his left side. These tremors would occur ¿sometimes for several hours. ¿ the tremor would then ¿disappear on its own later, as if the stimulation was turned back on. ¿ it was noted the patient lost his paresthesia and therapy within 24 hours of having his ins interrogated with a physician programmer at the time of report. Impedance testing was performed and found ¿fine¿ impedance values. X-ray imaging ¿didn¿t show any anomalies in the extensions/leads. ¿ the patient¿s stimulation was reprogrammed to a bipolar stimulation setting in an attempt at troubleshooting the situation; however, it was noted that ¿even with the bipolar stimulation there was a shocking sensation when touching the ins. ¿ the patient¿s ¿stimulation was still intermittent¿ and a revision surgery was planned for the patient as of 16 days after initial report. Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4743368
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« Reply #102 on: June 08, 2015, 06:02:54 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that the patient was feeling stimulation on the night prior to the date of this report but the patient¿s wife was worried that the patient¿s battery had gone dead since he could no longer move his legs like before and he was not feeling good. There were no falls or accidents. The last successful recharging session was a few days prior to the date of this report. Additional information received reported that it was unknown if the recharging frequency had matched the patient¿s settings. It was unknown if patient was trained and able to demonstrate effective recharging. The patient was in continuous mode. The cause of the event was determined and was device related. The patient had undergone a replacement. The rechargeable device was overstimulated even though settings were the same. It was unknown if the patient was recharging normally and if the patient was receiving effective therapy. The patient had been evaluated by neurosurgery and was reprogrammed on (b)(4) 2015. Patient status was unknown.

Manufacturer Narrative
Concomitant medical product: product id: 3389s-40, lot# v012773, implanted: (b)(6) 2007, product type: lead. Product id: 3389s-40, lot# v012773, implanted: (b)(6) 2007, product type: lead. Product id: 37092, lot# 328720001, implanted: (b)(6) 2012, product type accessory product id: 37651, lot# serial# (b)(4), product type: recharger. Product id: 64002, lot# n340417, implanted: (b)(6) 2012, product type: adapter. Product id: 748251, serial# (b)(4) implanted:(b)(4) 2007, product type: extension. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4804800
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« Reply #103 on: June 08, 2015, 06:03:45 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported the patient had chest pain, a loss of effect, and a lack of symptom control since the replacement of their implantable neurostimulators (ins). The patient had been having slurred speech and issues with controlling their tongue. On the day prior to this report, the patient had bit their tongue bad, which had made their speech even worse. The patient¿s jaw was tight and they almost broke a tooth. Every time the patient had their ins replaced, it took them three months to get the ins properly adjusted and for them to receive any benefit. The patient also had an increase in rigidity and dystonia in their neck and extremities with their left being worse than the right. The patient met with their healthcare professional (hcp) a day prior to this report because their pain was so bad they thought they were having a heart attack. The pain was located in the patient¿s chest near the ins and in their armpits. An x-ray was done and the patient was going to follow up with their cardiologist. The patient was evaluated by their cardiologist and cardiac etiology was ruled out. Impedances were checked and one of the contacts was not being used. Impedances of electrode zero were measured to be greater than 40,000 ohms on the left side. The left ins was programmed to 2-, 3+ at 4. 7v, 90 usec, and 145 hz. Impedances of electrode three were measured to be greater than 40 ,000 ohms on the right side. The right ins was programmed to 1+, 2- at 4. 2v, 90 usec, and 145 hz. Therapy impedances were measured to be within normal limits on both sides. The patient¿s hcp planned on reprogramming the ins to get efficacy. The cause of the event was not determined. A troubleshooting revision had been scheduled for (b)(6) 2015 due to the high impedances. During the revision, the hcp opened the right incision and noticed the bottom two screws on the ins were not tightened. The hcp loosened all four screws, dried off the extension, and retightened everything. The right side bottom connector for the ins and extension still seemed not tight and there was a small gap, but everything was tightened down. Impedances were then tested and all impedances were within normal limits. The same issue occurred when the left side incision was opened. After the revision, all impedances were within normal limits on both sides and no further troubleshooting was done. Refer to manufacturer report #3004209178-2015-09832.

Manufacturer Narrative
Concomitant products: product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v475868, implanted: (b)(6) 2010, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2015, product type implantable neurostimulator; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v443426, implanted: (b)(6) 2010, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4802318
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« Reply #104 on: July 15, 2015, 11:25:09 PM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the last few weeks had been terrible for the patient. She fell several times and had to go to the emergency room (er) to determine if her kneecap was fractured. Her mental state was deteriorating rapidly, as she cried for the better part of a day because of frustration in not being able to walk ten feet without falling down. Her leg strength was completely gone and simply would not support her body. The patient also had significant pain in her neck that never seemed to diminish. Her right side was not functional and she had developed restless leg, which would not allow her to sleep for any length of time. She could barely perform the basic functions to care for herself. Her emotions were running sky high and the reporter¿s fear was that she was in so much agony that she may harm herself in a fit of anger. The patient had minimal trouble walking before implant, but could hardly walk at the time of the report. She was at the two month mark post-surgery and had seen little improvement in her condition. Her overall condition was significantly worse at the time of the report than prior to implant. The only caution presented prior to surgery was that her iq might drop a few points. The reporter felt this was an understatement as the patient was actually acting ¿like an eight year old. ¿ the reporter questioned her overall competency. Adjustments to the device had yielded little improvement. The patient could not go on like this much longer as her health was deteriorating rapidly. Follow-up from the manufacturer representative (rep) reported that there was 50% or greater symptom reduction. The patient had three programming sessions and had a follow-up appointment scheduled with her doctor for (b)(6) 2015. It was unknown how the patient was doing, but the therapy was being delivered. The patient had not had her appointment with her doctor yet, so additional information will be requested at a later date. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant product/(s): product id: 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37642,serial# (b)(4), product type: programmer, patient. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3387s-40, lot# va0q888, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0q888, implanted: (b)(6) 2015, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4841044
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« Reply #105 on: July 15, 2015, 11:26:08 PM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 7482a51, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# va00dcw, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
It was reported that the patient¿s lead extension started to slide down his skull soon after implant. Eventually it slid off of his skull. Skin erosion was also reported. This was followed by decreased benefit. It was also reported that when the patient was on vacation he felt his device turning on and off. He felt tingling in his arm and leg like when the device was turned on/ off. The patient¿s implant was revised and replaced in 2013. The extension was removed but the lead remained implanted. No outcomes were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4813073
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« Reply #106 on: July 15, 2015, 11:27:19 PM »

Model Number 37602
Event Date 01/01/2013
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient had pain in her leg since 2013. The tens unit that the patient had was recommended for her leg and ankles. Information about ankle wounds that the patient had received continual wound care for was omitted due to the fact that it was unrelated. The patient had a loss of therapeutic effect and experienced a return of shaking that had occurred since august 2014. An eos/eol message was reported on 2015 (b)(6). The implantable neuro stimulator (ins) was checked yesterday, however, it was unknown when the last time the ins was checked using the programmer so it was unknown when the ins initially reached eri. It was recommended that the ins be replaced but the patient didn¿t want it replaced. The patient was to be scheduled for a battery replacement. It was unknown if the patient had a 50% or greater symptom reduction. Patient status remained unknown as the patient was ¿lost to follow-up and was last seen in 2010. " further follow-up is being conducted to obtain information. If additional information is received, a follow-up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4827854
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« Reply #107 on: August 08, 2015, 08:27:36 AM »

Model Number 37612
Event Date 04/14/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported the parkinson¿s disease patient experienced ¿symptoms or leg tremor and dyskinesia. ¿ these symptoms were reported to have appeared since a month prior to report and they did not improve following reprogramming during the month prior to report. The cause of the issue was not determined and the patient remained with leg tremors and dyskinesia during that time. Additional information reported the patient experienced the appearance of inarticulacy on (b)(6) 2015. The patient¿s physician increased their stimulation to 1. 95 volts as a result; however, there was ¿no improvement. ¿ additional information has been requested; a supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4915123
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« Reply #108 on: August 08, 2015, 08:28:20 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v333260, implanted: (b)(6) 2009, product type lead; product id 3389s-40, lot # v276341, implanted: (b)(6) 2009, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 37642, serial # (b)(4), product type programmer, patient. (b)(4).

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4898863
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« Reply #109 on: August 08, 2015, 08:29:06 AM »

Model Number 37612
Event Date 06/20/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that on (b)(6) 2015, the patient became inarticulate and had leg muscle stiffness. Reprogramming was done in (b)(6) 2015 and the patient¿s healthcare professional (hcp) turned stimulation up to 2. 5v from 2. 0v, but there was no symptom improvement. The cause of the event was not determined. The patient wanted to know if there are any better solutions. No interventions or outcome were reported regarding this event. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4949605
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« Reply #110 on: September 07, 2015, 07:43:44 AM »

Model Number 37603
Device Problem Communication or transmission issue
Event Date 07/21/2015
Event Type Malfunction
Manufacturer Narrative
Product id 3389s-40, lot# va0w79v, implanted: 2015 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2015 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient product id 3389s-40, lot# va0w79v, implanted: 2015 (b)(6); product type lead. (b)(4).

Event Description
A consumer reported that a poor communication screen was displayed on the patient programmer and the patient was getting poor communication. The patient was recently implanted and bandages and some swelling was present. On the day of this report, the patient met with a nurse for their health care provider and they turned down settings a little bit. Since the settings were turned down, the patient's hand was shaking really bad and the shaking was terrible. The shaking had started the day prior to this report and had gone away, but it was back today. The patient only had shaking in their hand and it was gradually getting worse. On 2015 (b)(6), the patient had cramping in their leg. The patient's indication for use is essential tremor and movement disorders. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5010764
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« Reply #111 on: September 07, 2015, 07:44:29 AM »

Model Number 37602
Event Date 07/11/2015
Event Type Injury
Event Description
It was reported the patient was admitted to the emergency room due to a loss of therapeutic benefit. The patient first noticed the loss of deep brain stimulation (dbs) benefit last night and today, the patient¿s arms and legs were moving wildly. The patient was brought to the emergency room by ambulance. Both of the patient¿s implantable neurostimulators (ins) were checked using the patient programmer and they were both on and at 3. 4v. Impedances were not checked. The patient indicated that prior to being taken to the emergency room, a nurse at their assisted living center may have made changes to their therapy, but they did not know what changes were made. The last reprogramming session was 3-4 months ago. The patient had no falls or trauma and had not been had any recent medical tests or environmental exposure. The reporter wanted to know if a manufacturing representative could check the inss. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3389-40, lot# v000631, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 37642, serial# (b)(4), implanted: (b)(6) 2012, product type: programmer, patient. Product id: 3389-40, lot# j0537580v, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4961817
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dennis100
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« Reply #112 on: September 19, 2015, 02:39:40 AM »

Model Number 7428
Event Date 08/11/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
The consumer via a manufacturer representative reported that the patient was implanted on (b)(6) 2013 due to parkinson's disease. On (b)(6) 2015, the patient's limbs felt rigid and it was difficult for them to walk. The patient suspected that the implantable neurostimulator (ins) was shut down. The patient requested a reprogramming on (b)(6) 2015. No troubleshooting was done and the event cause was not determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5043176
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dennis100
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« Reply #113 on: September 19, 2015, 02:40:56 AM »

Model Number 37612
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # va0vcce, implanted: (b)(6) 2015, product type lead; product id 3389s-40, lot # va0vcce, implanted: (b)(6) 2015, product type lead; product id 37651, serial # (b)(4), product type recharger; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2015, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2015, product type extension. (b)(4).

Event Description
A consumer reported that the patient whose indication for use was parkinson¿s dual and movement disorders had had a fall on (b)(6) 2015 and broke two fingers on the right hand and starting on (b)(6) 2014 the patient had a loss of stimulation and a return of shaking. The shaking the patient was experiencing was in both legs and the right hand. It was unknown what the patient was doing when they had lost therapy. The device was checked with the patient programmer and stimulation was on. The patient does not have the ability to adjust stimulation. Follow-up is being conducted to obtain information about troubleshooting done. If additional information is received a supplemental report will be submitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5042386
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