BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE RF

    MDR report key: 3890408 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03560
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    August 24, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NIK
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. THE REPORTED NO COMMUNICATION WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO LOW BATTERY VOLTAGE. THE DEVICE WAS TESTED ON THE BENCH AND OUT AUTOMATED TESTING EQUIPMENT AND NO HIGH CURRENT DRAIN SOURCES WERE FOUND. THE BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. THE CAUSE OF THE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP IT WAS NOT POSSIBLE TO INTERROGATE THE DEVICE. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30724 PROMOTE RF NIK ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 3213-36

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention