Model Number 1194 |
Device Problem
Migration (4003)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results, method, and conclusion codes along with the investigation results will be provided in final report.During processing of this complaint, attempts were made to obtain complete device and event information.
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Event Description
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Related manufacturer reference number: 1627487-2020-48690.It was reported the patients anchor migrated resulting in lead migration.Surgical intervention was undertaken on an unknown date wherein the anchor was replaced and the lead repositioned.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.During processing of this complaint, attempts were made to obtain complete device and event information.
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Search Alerts/Recalls
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