BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 1955268 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00143
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 29, 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
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY ANOMALY WAS VERIFIED IN THE LABORATORY. NO HIGH CURRENT MEASUREMENTS WERE FOUND DURING BENCH TESTING, AUTOMATED ELECTRICAL SYSTEM TESTING, AND TEMPERATURE CYCLING. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. NO ANOMALIES WERE FOUND THAT WOULD CAUSE BATTERY DEPLETION. THE CAUSE FOR THE PREMATURE BATTERY DEPLETION COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT PREMATURE ERI. 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 67 YR Required Intervention