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Model Number 6170 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided on the final report.During processing of this incident, attempts were made to obtain complete device information.Date of the event is estimated.
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Event Description
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Related manufacturer report number 1627487-2020-22589.It was reported that during a lead explant procedure, physician was unable to explant the entire lead and a partial of the lead remains subcutaneously implanted in the brain tissue.It is unknown which lead had the issue therefore both leads are being reported.A new lead was successfully implanted.Patient was stable.
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Manufacturer Narrative
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Correction: upon review, the lead should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.
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Search Alerts/Recalls
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