BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO VR

    MDR report key: 5860474 · Received August 9, 2016

    Report

    Report Number
    3004209178-2016-16065
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    May 15, 2016
    Report Date
    May 15, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WAS UNABLE TO BE INTERROGATED. THERE WAS A SINGLE AMBER BAR INDICATING NO TELEMETRY WAS PRESENT. 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
    514078 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR