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Model Number MN10450-90A |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2022 |
Event Type
Injury
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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 axium lead, model: mn10450-90a, udi: (b)(4), serial: (b)(4), batch: 7367668.
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Event Description
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It was reported that during a revision procedure the physician was unable to completely remove one of the leads leaving a fragment implanted.There is no intervention planned at this time.The investigation was unable to determine which lead fragmented.
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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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