BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 1955119 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00132
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 15, 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
    WV
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED COMMUNICATION ANOMALY WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A LOW BATTERY VOLTAGE. NO HIGH CURRENT DRAIN SOURCES WERE FOUND DURING TESTING. THE BATTERY WAS SENT OUT TO THE VENDOR FOR FURTHER EVALUATION. THE CAUSE FOR THE PREMATURE BATTERY DEPLETION COULD NOT CONCLUSIVELY BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER FEELING SYMPTOMATIC DUE TO TWO SECOND PAUSES. IT WAS OBSERVED THAT NO COMMUNICATION COULD BE ESTABLISHED WITH THE DEVICE. TROUBLESHOOTING WAS PERFORMED, BUT WAS UNSUCCESSFUL. BATTERY LONGEVITY REVEALS THAT THE DEVICE IS NOT WITHIN THE EXPECTED LONGEVITY PERFORMANCE.

    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 73 YR Required Intervention