BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT RF DR

    MDR report key: 2242831 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06202
    Event Type
    Malfunction
    Date Received
    September 11, 2011
    Date of Event
    June 24, 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. (B)(4); FAILURE (EVENT) OBSERVED DURING ANALYSIS. ANALYSIS FOUND THAT NO COMMUNICATION COULD BE ESTABLISHED UPON RECEIPT OF THE DEVICE DUE TO A DEPLETED BATTERY AS A RESULT OF HIGH CURRENT. THE HIGH CURRENT DRAIN WAS DUE TO AN ANOMALOUS INTEGRATED CIRCUIT COMPONENT WITHIN THE HYBRID.

    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