BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT RF DR

    MDR report key: 2242857 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06200
    Event Type
    Malfunction
    Date Received
    September 11, 2011
    Date of Event
    June 7, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS FOUND THE DEVICE IN BACKUP VVI MODE AS RECEIVED. THE CAUSE OF THE BACKUP MODE WAS PARITY ERRORS. (B)(4). (B)(6). NO COMPLAINT WAS RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1