It was reported the patient experienced a loss of stimulation.Diagnostics revealed high impedances of the patient¿s lead, and reprogramming was unable to resolve the issue.To address the issue, the physician performed a revision on (b)(6) 2020 where it was discovered there was a kink in the lead at the anchor site.The physician explanted the lead and implanted a new one, which resolved the issue.
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A case of high impedance due to lead damage was reported to abbott.During revision, the physician noted that the lead was kinked around the anchor.The lead was replaced to reestablish effective therapy.No implants were returned for evaluation/disposal.As a result, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.Based on the information received, a single definitive root cause for the reported issue was unable to be conclusively determined, however the lead damage is consistent with an over stress situation in-vivo.
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