BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 1954685 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00145
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 14, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. 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

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. TROUBLESHOOTING WAS PERFORMED, HOWEVER, THE DEVICE WOULD STILL NOT INTERROGATE. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention