BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIRM

    MDR report key: 3925703 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15611
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 29, 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 Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM FOR SYMPTOMATIC SINUS BRADYCARDIA. THE IMPLANTABLE CARDIAC MONITOR COULD NOT BE INTERROGATED. NO SOURCES OF INTERFERENCE COULD BE DETERMINED. THE PATIENT RECENTLY HAD AN MRI. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405258 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST. JUDE MEDICAL, INC., CRMD DM2100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention