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Author Topic: Deep brain stimulator - Falls  (Read 37801 times)
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dennis100
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« Reply #90 on: August 08, 2015, 08:24:09 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4898863
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dennis100
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« Reply #91 on: September 07, 2015, 06:45:41 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5038464
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dennis100
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« Reply #92 on: September 07, 2015, 06:46:34 AM »

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

Manufacturer Narrative
(b)(4).

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

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

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

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

Model Number 37601
Event Type Injury
Event Description
A consumer reported the patient was hospitalized on (b)(6) 2015. A week before the hospitalization the patient was falling and getting weak. The patient had a bowel infection called "c diff. " at the time of this report, the patient was home and the infection was getting better, but the patient's mental state was not. The patient was non-responsive. Physical therapy came to the patient's home, sat them up, and asked them to move their leg, but they were non-responsive. The implantable neurostimulator (ins) was checked and it seemed fine. The patient's indication for use is parkinson's dual and movement disorders. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v091127, implanted: (b)(6) 2008, product type lead; product id 3389s-40, lot # v091127, implanted: (b)(6) 2008, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a5,1 serial # (b)(4), implanted: (b)(6) 2008, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2008, product type extension. (b)(4).

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