Model Number 37612 |
Device Problems
Break (1069); Low impedance (2285); Electrical Shorting (2926)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/19/2018 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 3387s-40, lot# v571560, implanted: (b)(6) 2011, product type: lead.Other relevant device(s) are: product id: 3387s-40, serial/lot #: v571560, (b)(6), (b)(4) - other applies.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 consumer via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for parkinson's dual and movement disorders.It was reported that the patient called the rep to report to them that they were having a lead revision for the right stn on (b)(6) 2018.The doctor's notes indicated that they did a ct scan and the lead appeared to have a possible break at the stimlock and a possible break at the connector occipital region.Internal short circuit is suspected.The issue is not resolved at this time of the report.No symptoms were reported.No further complications were reported or anticipated.
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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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Manufacturer Narrative
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Concomitant medical products: updated explant date: product id: 3387s-40, lot# v571560, implanted: (b)(6) 2011, explanted: (b)(6) 2018, product type: lead.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 was received from the manufacturing representative indicating that the cause of the lead break is unknown and the issue is not yet resolved.The lead was explanted on (b)(6) 2018 and will be returned for analysis.This information was confirmed with the physician.
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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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Additional information was received from the rep correcting that the lead will be explanted on (b)(6) 2018.It was previously reported that it was explanted.
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Manufacturer Narrative
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Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
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Event Description
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No additional information was received.
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Manufacturer Narrative
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Analysis of the lead (lot # v571560) revealed that all body conductors were broken 9.9cm from the distal end of the lead.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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