The unique device identifier (udi) is not provided because the manufacture date is before sep 24, 2014.During processing of this incident, attempts were made to obtain complete patient information (weight).Further information was requested but not received." based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Related manufacturer reference numbers: 1627487-2023-05390, 1627487-2023-05393, 1627487-2023-05394.It was reported that during a procedure of ipg explant (3006705815-2023-06925), physician cut all the wires above the battery and in the area of the battery pocket on (b)(6) 2023 and then left it implanted and non-functional.
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