BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 2242619 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06204
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    June 12, 2011
    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
    CA
    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 BELOW THE EXPECTED LIMITS. THE BATTERY WAS SENT TO THE VENDOR FOR FURTHER ANALYSIS. AN INTERNAL BATTERY ANOMALY WAS FOUND TO CAUSE THE PREMATURE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION.

    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 71 YR Required Intervention