BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 1411377 · Received July 9, 2009

    Report

    Report Number
    2017865-2009-02065
    Event Type
    Injury
    Date Received
    July 9, 2009
    Date of Event
    April 20, 2009
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMAP880086
    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 THE PULSE GENERATOR AS RECEIVED EXHIBITED NO OUTPUT DUE TO THE OPERATING MODE BEING PROGRAMMED TO OVO. THE PACING IN THIS MODE IS TURNED OFF. THE DEVICE WAS IN OVO MODE DURING THE EXPLANT, WHICH IS WHY THERE WAS NO OUTPUT. OVO MODE IS NOT RECOMMENDED FOR PACEMAKER DEPENDENT PATIENTS WHO MIGHT BE AFFECTED BY EVEN A SHORT CESSATION OF DEVICE OPERATION. WHEN THE OPERATING MODE WAS TURNED TO DDD, NORMAL DEVICE FUNCTION ENSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACEMAKER DEPENDENT PATIENT PRESENTED WITH PRESYNCOPE AND FALLS. INTERROGATION SUGGESTED THAT VENTRICULAR IMPEDANCE HAD FALLEN, SO THE VENTRICULAR LEAD WAS REPLACED. THE PATIENT RETURNED WITH FURTHER EPISODES OF PRESYNCOPE AND LOSS OF CONSCIOUSNESS. THE LEAD HAD DISLODGED, BUT UPON REPOSITIONING AND RECONNECTING TO THE DEVICE, THERE WAS STILL NO OUTPUT. THE PULSE GENERATOR WAS REPLACED. PACING WAS IMMEDIATELY EFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY ADX XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5386 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention