Model Number MN10450-50A |
Device Problem
Migration (4003)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 04/04/2024 |
Event Type
Injury
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Event Description
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It was reported that patient experienced ineffective therapy due to lead migration.Surgical intervention is pending to address the issue.The investigation was unable to determine the lead that was associated with the issue.
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Manufacturer Narrative
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Date of event is estimated.Additional components potentially involved in the event include: common device name: drg: lead, model: mn10450-50a, udi: (b)(4), serial:(b)(6), batch: 10139508.
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Manufacturer Narrative
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It was reported to abbott, a patients s1 lead had migrated out of the sacral foramen.The patient underwent a revision.During removal of the migrated r s1 lead, the left lead retracted from the sacral foramen.Due to this complication, the physician explanted and replaced both leads.Effective therapy was restored.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
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Event Description
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Additional information received identified that patient underwent surgical intervention wherein, the leads were explanted and replaced.Effective therapy was restored post operatively.
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Search Alerts/Recalls
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