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Author Topic: Deep brain stimulator - Programming  (Read 24339 times)
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dennis100
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« Reply #60 on: July 15, 2015, 11:45:33 PM »

Model Number 37602
Event Type Injury
Event Description
It was reported that the patient was unable to adjust stimulation. It was also reported that the patient was experiencing freezing, loss of reflexes, and couldn¿t move her body at times. The symptoms were worsening. The patient also had a swollen foot. The patient¿s neurologist told them the stimulation frequency needed to be decreased by (b)(6), but the patient¿s daughter was not comfortable adjusting the stimulation. It was also noted that right after implant in (b)(6) ¿they just cranked it up and that was it. ¿ the patient was scheduled for an appointment with their health care provider on (b)(6) 2015. The patient was waiting for a company representative to be present to help program her device. It was reported a month later that the patient saw her doctor two weeks ago and that she did not have an appointment on (b)(6) 2015. The doctor commented that the patient does not seem to take their advice including ¿wrt¿ medications. The patient did not have additional surgery but was waiting to have surgery done. The doctor did not feel that there was much a company representative could do. No additional follow up information was available. 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=4860153
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dennis100
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« Reply #61 on: July 15, 2015, 11:46:22 PM »

Model Number 37601
Event Date 05/29/2015
Event Type Injury
Event Description
It was reported the implantable neurostimulator (ins) prematurely depleted. The week prior to this report the patient¿s ins was replaced due to reaching elective replacement indicator (eri). During the replacement surgery, impedances of the new ins were measured to be okay and the ins was at 3. 17v. Two days later, the patient saw an eri message and the ins had depleted to 2. 6v. The patient met with their healthcare professional (hcp) and the hcp interrogated the ins. The clinician programmer displayed an eri message and the battery was at 2. 97v. One day later, the patient programmer displayed an eri message and the ins was at 2. 6v. On the day of this report, the patient met with a manufacturing representative and the ins was at 2. 52v. An eri message was displayed on both the patient programmer and the clinician programmer. The following day the patient reported the ins had changed from 2. 57 to 2. 80v on the patient programmer. The patient was unsatisfied and scared about the rapid battery depletion the first week after the ins was replaced. The ins was going to be explanted if the battery went from eri to end of service as rapidly as the depletion in the first days since implant. No outcome was 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
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4853530
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dennis100
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« Reply #62 on: August 08, 2015, 08:35:32 AM »

Model Number 37612
Event Date 06/10/2015
Event Type Malfunction
Event Description
It was reported the patient programmer was not powering on and the recharger displayed a ¿call your doctor¿ icon and a 375 antenna failure error code. New batteries were tried in the programmer, but the issue was not resolved. The new batteries were brand new and the patient confirmed they were positioned correctly. The patient was not able to recharge the implantable neurostimulator (ins). When the patient tried to recharge the ins, they saw the ¿call your doctor¿ icon. Normally, the patient recharged just about every day. The patient was having a return of symptoms and their arm was shaking terribly since the day prior to this report. Upon device return, analysis of the patient programmer found the antenna jack was resoldered as a preventative measure. Upon device return, analysis of the recharger found the recharge antenna failed. 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: 3387s-40, lot# v181305, implanted: (b)(6) 2009, product type: lead. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: neu_unknown, serial# unknown, product type: unknown. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4882203
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dennis100
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« Reply #63 on: August 08, 2015, 08:36:19 AM »

Model Number 37601
Event Date 06/14/2015
Event Type Malfunction
Event Description
It was reported that there was a problem with the patient programmer and the patient got a splash screen yesterday when they tried to switch programs. The patient switched between groups c and d for day and night. Due to not being able to switch groups the patient had difficulty the night prior to this report. The programmer batteries were replaced and the patient was able to connect with the implantable neurostimulator (ins). The patient had contacted a manufacturing representative the day of this report. 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# v878980, implanted: (b)(6) 2012, product type: lead. Product id: 3387s-40, lot# v836480, implanted: (b)(6) 2012, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. 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).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4888299
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dennis100
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« Reply #64 on: September 07, 2015, 08:05:19 AM »

Model Number 7426
Event Type Malfunction
Event Description
The patient had an mri on his head and shoulders to check the hematoma which caused the implantable neurostimulator (ins) to lose programs/ information. The mri was done every few years. The patient was indicated for movement disorders. No further information was provided. If additional information is received, a follow-up report will be sent.

Manufacturer Narrative
Concomitant: product id 7426, serial# (b)(4), implanted: 2004-(b)(6), product type implantable neurostimulator. Product id 3387-40, lot# j0428226v, implanted: 2004-(b)(6), product type lead. Product id 748251, serial# (b)(4), implanted: 2004-(b)(6), product type extension. Product id 748251, serial# (b)(4), implanted: 2004-(b)(6), product type extension. Product id 3387-40, lot# j0444274v, implanted: 2004-(b)(6), product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4994664
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