BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLIA MRI CRT-D SURESCAN

    MDR report key: 10884903 · Received November 23, 2020

    Report

    Report Number
    3004209178-2020-20451
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    November 11, 2020
    Report Date
    November 23, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    UDI-DI
    00643169929616
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: M7700-31 MECHANICAL VALVE. IMPLANTED: (B)(6) 1993; 6725 CRDM ADAPTOR. IMPLANTED: (B)(6) 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A PARTIAL POWER ON RESET (POR), WHICH OCCURRED AT THE BEGINNING OF THE INTERROGATION. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349075 AMPLIA MRI CRT-D SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTMB1D1 00643169929616

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 694765 LEAD, 419388 LEAD