ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD
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Model Number 3186 |
Device Problem
Fracture (1260)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 06/10/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.Additional components potentially involved in the event include: common device name: lead, model: 3186ans, udi: 05415067017246, serial: (b)(4), batch: a000102919.
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Event Description
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It was reported one of the leads fractured.As a result, surgical intervention was undertaken wherein the patients leads were explanted and replaced with a single paddle lead 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 event could not be conclusively determined.During processing of this complaint, attempts were made to obtain complete device and event information.
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Search Alerts/Recalls
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