BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR, SJ4 CONNECTOR

    MDR report key: 1831078 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03587
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 21, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS VERIFIED IN THE LABORATORY. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, THE DEVICE WAS FOUND TO BE OUTSIDE OF THE EXPECTED LIMITS. THE DEVICE WAS ANALYZED WITH A NEW BATTERY AND WAS FOUND TO BE NORMAL. THE BATTERY WAS SENT OUT TO THE VENDOR FOR FURTHER EVALUATION, AND AN INTERNAL BATTERY ANOMALY WAS FOUND, WHICH CAUSED THE PREMATURE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MERLIN.NET TRANSMISSION NOTED THE DEVICE REACHED ERI. BASED ON THE BATTERY LONGEVITY CALCULATION, IT APPEARS THAT THE DEVICE HAD DEPLETED RAPIDLY SINCE IMPLANT. THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 1

    THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT PLUS DR, SJ4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention