Model Number MN10450-50A |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: drg slim tip lead, model: mn10450-50a, udi: (b)(4), serial: (b)(4), batch: 7455659.
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Event Description
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It was reported that during an elective system explant on (b)(6) 2022, that part of a t12 lead remained and was unable to be removed.Surgical intervention may be pending to address the issue.
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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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Additional information received indicates that surgical intervention was undertaken on (b)(6) 2022, where the part of the lead remaining was explanted.
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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.
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Search Alerts/Recalls
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