BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIRM

    MDR report key: 2240277 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05935
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 25, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    MXC
    PMA / PMN Number
    K081365
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THAT THE DEVICE COULD NOT BE INTERROGATED DUE TO A BATTERY ANOMALY. THE BATTERY WAS NOT ABLE TO SUPPLY THE REQUIRED CURRENT TO THE HYBRID DURING INTERROGATION. THIS RESULTED IN A CURRENT-LIMITING EFFECT AND RESULTED IN THE BATTERY VOLTAGE FALLING BELOW THE MINIMUM THRESHOLD FOR COMMUNICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOOP RECORDER COULD NOT BE INTERROGATED AND DISPLAYED BACKUP OPERATION. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION DM2100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention