BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA MRI XT DR SURESCAN

    MDR report key: 10252756 · Received July 9, 2020

    Report

    Report Number
    3004209178-2020-11896
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    January 27, 2020
    Report Date
    July 9, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    UDI-DI
    00643169720497
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR DEVICE "BURST." THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOTED TO HAVE BEEN REMOVED AND REPLACED ABOUT 3 MONTHS LATER WITH A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717235 EVERA MRI XT DR SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDMB1D4 00643169720497

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R