Model Number 3186 |
Device Problems
Fracture (1260); High impedance (1291)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 07/29/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Related manufacturer reference number: 3006705815-2021-03894.It was reported that stimulation on the leads was auto reducing.Both leads displayed high impedance.X-rays revealed potential fracture in one of the lead.Surgical intervention may take place to address the issue.
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain weight 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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Additional information received indicated the patient underwent surgical intervention wherein both of the leads were explanted and replaced to address the issue.Therapy was restored postoperatively.
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Manufacturer Narrative
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The reported event of high impedances was confirmed.Both leads were returned complete.Microscopic inspection identified a kink in the lead body where all of the internal wires were broken followed by a cam impression mark.The fracture wires are consistent with overstress condition that leads may have been subjected to while in vivo.
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Search Alerts/Recalls
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