Device 4 of 4.Reference mfr report#3006705815-2019-00472.Reference mfr report#3006705815-2019-00473.Reference mfr report#1627487-2019-02829.It was reported that the patient could not place the ipg in the surgery mode.During reprogramming the leads displayed high impedances.Also, x rays showed the leads were potentially fractured.As a result, surgical intervention was undertaken wherein the leads and the anchors were explanted and replaced.Therapy was restored post-operatively.The physician had cut the anchors during the original implant and therefore the anchors are made reportable.
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