BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO VR

    MDR report key: 2953002 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01881
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAS HAD EXTREMELY RAPID BATTERY DEPLETION OVER SEVEN MONTHS WITH NORMAL VALUES AND SETTINGS AND NO THERAPIES PROVIDED. 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
    56068 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR 6947 IMPLANTABLE TACHY LEAD