BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE SCAN IMPLANTABLE DEFIBRILLATOR/PACEMAKER

    MDR report key: 12160368 · Received July 12, 2021

    Report

    Report Number
    MW5102479
    Event Type
    Malfunction
    Date Received
    July 12, 2021
    Date of Event
    March 29, 2021
    Report Date
    July 8, 2021
    Manufacturer
    MEDTRONIC INC
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC ICD PACEMAKER/DEFIBRILLATOR WITH RESYNCHRONIZATION THERAPY, (CLARIA MRI QUAD CRTD DTMA-1QQ), SERIAL NO. (B)(4), WAS IMPLANTED ON (B)(6) 2021 WITH INFORMATION THAT IT SHOULD HAVE A BATTERY LIFE OF 7+ YEARS. AT A CHECK-UP ON (B)(6) 2021, LESS THAN A MONTH AFTER IMPLANTATION, I WAS TOLD THAT THE REMAINING BATTERY LIFE IS 2.75 YEARS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051382 SURE SCAN IMPLANTABLE DEFIBRILLATOR/PACEMAKER DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC INC DTMA-1QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR