BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT RF DR

    MDR report key: 3090038 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01094
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 9, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER AFTER RECEIVING A PATIENT NOTIFICATION. THE DEVICE WAS FOUND IN BACKUP RESET MODE DUE TO A POWER ON RESET. IT WAS NOTED THAT THE PATIENT HAD A VT ABLATION PROCEDURE. THE ISSUE WAS RESOLVED BY DOWNLOADING THE DEVICE CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191777 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR