BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 1896041 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04382
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 27, 2010
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMMUNICATION ANOMALY WAS CONFIRMED IN THE LABORATORY. BASED ON AVAILABLE PARAMETER AND USAGE INFORMATION, THE DEVICE WAS FOUND TO BE BELOW EXPECTED LIMITS. NO SOURCES OF HIGH CURRENT DRAIN WERE FOUND THROUGHOUT TESTING. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER ANALYSIS. NO ANOMALIES WERE FOUND THAT WOULD CAUSE BATTERY DEPLETION. THE CAUSE OF THE DEPLETION WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED.

    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 71 YR Required Intervention