BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY VR, DF-4 CONNECTOR

    MDR report key: 2902552 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00421
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    October 11, 2012
    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 Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. A LONGEVITY CALCULATION WAS PERFORMED BASED ON PROGRAMMED SETTINGS AND USAGE DATA AND THE DEVICE DID NOT MEET ITS LONGEVITY REQUIREMENT. WITH AN EXTERNAL POWER SUPPLY CONNECTED, THE DEVICE TESTED NORMAL AND ALL SPECIFICATIONS WERE MET. THE BATTERY WAS SENT TO THE MANUFACTURER BUT NO ANOMALIES WERE FOUND. THE CAUSE OF THE BATTERY 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 RAPID BATTERY DEPLETION WAS OBSERVED. THE PATIENT RECEIVED A NOTIFIER THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR. FOUR DAYS LATER, THE PATIENT RECIEVED A NOTIFIER THAT THE DEVICE REACHED END OF SERVICE. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9003 FORTIFY VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR