Related manufacturer reference number: 3006705815-2021-03206.It was reported that following the implant procedure the patient experienced left foot pain due to nerve irritation.As a result, surgical intervention was undertaken wherein the leads were explanted.The pain improved following explant,.
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The event of pain at lead site was reported to abbott.The patient was experiencing pain in the left foot due to nerve irritation immediately after implant surgery.The doctor decided to remove both leads.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.During processing of this complaint, attempts were made to obtain complete device, patient and event information.
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