BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 1954762 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00151
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 15, 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
    PA
    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 ANOMALY WAS CONFIRMED IN THE LABORATORY. BASED ON AVAILABLE INFORMATION THE DEVICE WAS FOUND TO BE BELOW EXPECTED LIMITS. NO COMMUNICATION COULD BE ESTABLISHED DUE TO LOW BATTERY VOLTAGE. INITIALLY A HIGH CURRENT DRAIN SOURCE WAS FOUND IN THE RF TELEMETRY. THE FAILURE MODE WAS LOST AND COULD NOT BE REPRODUCED. NO ANOMALIES WERE FOUND DURING TESTING. THE BATTERY WAS RETURNED TO THE VENDOR. NO ANOMALIES THAT COULD CAUSE BATTERY DEPLETION WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ERI PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED.

    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 43 YR Required Intervention