Model Number MN10450-50A |
Device Problems
Insufficient Information (3190); Migration (4003)
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Patient Problems
No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)
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Event Date 11/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer report number 1627487-2020-48601 ; 1627487-2020-48602.It was reported that a lead revision is planned for an unknown reason.No additional information was provided.
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Event Description
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Additional information indicated that the patient lost therapy due to lead migration.As a result, surgical intervention occurred wherein the leads were explanted and replaced.
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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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Search Alerts/Recalls
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