BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIRM

    MDR report key: 4072313 · Received September 9, 2014

    Report

    Report Number
    2017865-2014-16293
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    July 1, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    MXC
    PMA / PMN Number
    K081365
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS CONFIRMED THE BATTERY ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR EXHIBITED AN ERROR MESSAGE AND TELEMETRY WAS LOST. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556096 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST. JUDE MEDICAL, INC., CRMD DM2100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention