BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II VR

    MDR report key: 2951474 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01546
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 8, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 BY REMOTE TRANSMISSION THE PATIENT RECEIVED SEVERAL INAPPROPRIATE SHOCKS DUE TO THE DEFIBRILLATOR DISCRIMINATOR NOT FILTERING OUT RAPID VENTRICULAR RESPONSE TO ATRIAL FIBRILLATION. THE DEFIBRILLATOR REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56011 MAXIMO II VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI D284VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Life Threatening 6947 IMPLANTABLE DEFIBRILLATOR LEAD