BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 3556609 · Received December 27, 2013

    Report

    Report Number
    3556609
    Event Type
    Malfunction
    Date Received
    December 27, 2013
    Date of Event
    November 26, 2013
    Report Date
    December 27, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT IS A (B)(6) YEAR OLD MAN WITH A HISTORY OF VENTRICULAR FIBRILLATION ATRIAL FIBRILLATION, S/P AV NODE ABLATION AND NON-ISCHEMIC CARDIOMYOPATHY, WHOSE DEVICE HAS REACHED ELECTIVE REPLACEMENT INDICATORS AND WAS SCHEDULED FOR BATTERY REPLACEMENT. HE ALSO HAS A SPRINT-FIDELIS LEAD THAT IS ON RECALL AND HAS ELECTED TO UNDERGO LEAD EXTRACTION AND INSERTION OF A NEW LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677421 SPRINT FIDELIS LEAD, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC, INC. 6949 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR NOT APPLICABLE.