Model Number 37602 |
Device Problems
Premature Discharge of Battery (1057); Low impedance (2285); Device Displays Incorrect Message (2591); Insufficient Information (3190)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins) for parkinsons dual and movement disorders.The rep reported that the patient's ins was at end of service (eos) as displayed by the clinician programmer.The rep reported that last year the patient's therapy z was 800 ohms, while today at eos, the battery measured 400 ohms.The rep reported no program changes were made.The rep reported that the other side was about the same settings and the battery was still ok.The rep reported it was unknown when the patient lost therapy.The rep reported that the ins or other components would be revised if they needed replacing next week.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Information references the main component of the system and other applicable components are: product id 37602 lot# (b)(4) implanted: (b)(6)2016 explanted: (b)(6)2018 product type implantable neurostimulator product id 7482a51 lot# (b)(4) implanted: (b)(6)2008 explanted: (b)(6)2018 product type extension if information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from a manufacturer representative (rep).The rep reported the patient was having an ins and possible extension replacement surgery on (b)(6)2018.The rep reported that the patient's healthcare provider (hcp) suspected that the electrode or extension possessed a short circuit, causing the impedances to drop from 800 ohms to 400 ohms, thus driving higher current which would prematurely drain the ins.The rep reported that the patient had a replacement surgery on (b)(6)2018 and both the ins and extension were replaced on the right side, resolving the impedance issue.The rep reported that prior to the replacement, the therapy impedance read 494 ohms and 7.811ma.Following the replacement, the therapy impedance read 993 ohms, and 4.106ma.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Analysis of the implantable neurostimulator (ins) (b)(4) revealed that the battery was at normal end of life and the telemetry and output were okay.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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