Model Number 3189 |
Device Problem
Migration (4003)
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Patient Problems
Fall (1848); No Consequences Or Impact To Patient (2199)
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Event Date 05/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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Investigation results will be provided in the final report.
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Event Description
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Related manufacturer reference number: 1627487-2019-06476.It was reported that the patient experienced a lead migration.The patient experienced a fall on (b)(6) 2019 that could have contributed to the migration of the leads.X-rays were taken, confirming lead migration.Surgical intervention is being considered for the future.
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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 incident could not be conclusively determined.
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Event Description
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It was reported that the patient underwent lead revision surgery on (b)(6) 2019 wherein the lead was explanted and replaced.Follow up identified the patient was doing well postoperatively and no complications were identified.
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Search Alerts/Recalls
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