ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD
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Model Number 3186 |
Device Problems
Fracture (1260); Migration (4003)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/23/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this complaint, attempts were made to obtain patient weight.Further information was requested but not received.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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It was reported the patient fell and later experienced ineffective therapy.Diagnostic imaging indicated the t9 lead migrated and fractured.In turn, surgical intervention was undertaken wherein the lead was explanted and replaced to address the issue.Reportedly, effective therapy was established post-operatively.
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Search Alerts/Recalls
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