BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRONY II SR+

    MDR report key: 1073282 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02081
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    November 3, 2007
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE BATTERY WAS DEPLETED PREMATURELY DUE TO HIGH CURRENT DRAIN CAUSED BY A LEAKY CAPACITOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WAS PREMATURELY DEPLETED. BATTERY DATA DECREASED FROM 2.78 V ON DECEMBER 12, 2006 TO NO BATTERY VOLTAGE (DASHED LINE) ON OCTOBER 1, 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRONY II SR+ IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2525T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention