BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIRM

    MDR report key: 2240468 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05931
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 27, 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. 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.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4) - FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT TWO CIRCUIT BLOCKS WERE SHORTED WHICH PREMATURELY DRAINED THE LOOP RECORDER'S BATTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    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