BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIRM

    MDR report key: 4191728 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04579
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    February 9, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    MXC
    PMA / PMN Number
    K081365
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. 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. EVALUATION: ANALYSIS WAS NORMAL. NO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE IMPLANTABLE CARDIAC MONITOR THE PHYSICIAN SAW A SPARK WHILE USING ELECTROCAUTERY. SUBSEQUENTLY, THE DEVICE EXHIBITED BACKUP VVI OPERATION. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33707 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST. JUDE MEDICAL, CRMD DM2100

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention