Model Number 3386 |
Device Problems
Fracture (1260); High impedance (1291)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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Corrected data: (brand name and common device name), additional device information, (pma/510(k) #, and device manufacture date.
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Manufacturer Narrative
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The event date is unknown.The results/method and conclusion codes along with the investigation results will be provided in the final report.
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Event Description
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This report is related to a (b)(6) patient.It was reported high impedance was observed in reference to the patient's extension.As a result, the patient's extension was explanted and replaced.Surgical intervention addressed the patient's issue.
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Manufacturer Narrative
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The report event of high impedance was confirmed.Analysis of the returned lead extension found all internal wires broken and detached in the header and strain relief.The fracture observed would be consistent with an overstress condition or sudden event that the extension was subjected to while still in vivo.
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Search Alerts/Recalls
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