ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD
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Model Number 3186 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2021 |
Event Type
Injury
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Event Description
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Related manufacturer reference number: 3006705815-2021-02040.It was reported that the patient's leads were cut during an elective ipg replacement on (b)(6) 2021.The physician explanted both leads and replaced them with new ones during the same procedure.Post-operatively, stimulation therapy was restored.
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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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