Date of event is estimated.During processing of this complaint, attempts were made to obtain patient¿s weight.Further information was requested 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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Related manufacturer reference number: 1627487-2020-22488, related manufacturer reference number: 1627487-2020-22489, related manufacturer reference number: 3006705815-2020-02642, related manufacturer reference number: 1627487-2020-22491.It was reported that patient experienced ineffective therapy.Attempts to reprogram were unsuccessful.As a result, surgical intervention was undertaken on (b)(6) 2020, wherein the entire system was explanted.
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