Model Number 1192 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2021 |
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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It was reported that during a lead revision (related manufacturer reference number: 1627487-2020-03398) it was discovered that the patient's swiftlock anchor was fractured from the distal stain relief end from the locking mechanism/proximal end.As a result, the anchor was partially explanted.The distal end remains insitu in muscle as the physician was unable to remove it safely.
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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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