BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS VR, DF-4 CONNECTOR

    MDR report key: 1954795 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00458
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 1, 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

    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 PREMATURE BATTERY DEPLETION WAS VERIFIED IN THE LABORATORY. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, THE DEVICE LONGEVITY WAS FOUND TO BE BELOW THE EXPECTED LIMITS. NO HIGH CURRENT DRAIN SOURCES WERE FOUND DURING BENCH, AUTOMATED ELECTRICAL, TEMPERATURE, AND HUMIDITY TESTING. THE BATTERY WAS SENT OUT TO THE VENDOR FOR FURTHER EVALUATION. AN INTERNAL BATTERY ANOMALY WAS FOUND TO CAUSE THE PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE CLINIC WITH THE DEVICE AT ERI. PATIENT REPORTED RECEIVING A VIBRATORY ALERT. THE DEVICE WAS EXPLANTED DUE TO SUSPECTED PREMATURE BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT PLUS VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention