Event and therapy date is estimated.Explant date is unknown.Further information requested but not available.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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Manufacturer report number:1627487-2020-04519, 1627487-2020-04521,1627487-2020-04523.It was reported that the patient¿s remaining part of the lead eroded through patient¿s scalp (reference mfr # 1627487-2020-04443, 1627487-2020-04444, 1627487-2020-04446,1627487-2020-04450 for partial lead explant).As such, the remaining portion of the lead was removed four to six months ago on unknown date.
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