Model Number MN10450-50A |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Related manufacturer report number: 1627487-2023-01705.It was reported that during a surgical procedure on (b)(6) 2023, lead fracture occurred during explant and a portion of the l3 and l4 leads remains in-situ.As a result, surgical intervention may be pending to address the issue.
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Manufacturer Narrative
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Correction: b5 updated to reflect associated reports.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 during a surgical procedure on (b)(6) 2023 (related manufacturer report number: 3006705815-2023-01954, 1627487-2023-01458, 1627487-2023-01456, 1627487-2023-01457) lead fracture occurred during explant and a portion of the l3 and l4 leads remains in-situ.As a result, surgical intervention may be pending to address the issue.
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Search Alerts/Recalls
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