Model Number 1192 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/13/2023 |
Event Type
Injury
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Event Description
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Related manufacturer reference number: 3006705815-2023-07813 related manufacturer reference number: 3006705815-2023-07814 it was reported the patient's one leads had migrated and the other lead was pulled out had a broken anchor as well.The issue was confirmed via x-rays.Surgical intervention was undertaken on (b)(6) 2023 during which the existing leads and anchor were explanted and replaced with a single lead.Therapy was successfully restored.
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Manufacturer Narrative
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Date of event is estimated.
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Manufacturer Narrative
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The report event of broken anchor was confirmed.As received, the returned swift lock anchor been cut in two pieces was found.The cause of the reported event is consistent with damage during use.
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Search Alerts/Recalls
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