BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY ADX SR

    MDR report key: 1073353 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02147
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    May 1, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED INTER- MITTENT TELEMETRY. COMMUNICATION WAS LOST DURING THREE ATTEMPTS TO ACCESS AUTOCAPTURE AND WITH ANY OTHER DIAGNOSTIC TESTING. BEFORE COMMUNICATION WAS LOST MEASURED BATTERY DATA WAS OBTAINED AT 2.72 V, 14 UA, 6.6 KOHMS WITH AN ESTI- MATED FIVE TO TEN MONTHS REMAINING LONGEVITY. PHYSICIAN DECIDED TO LEAVE THE DEVICE IN UNTIL ELECTIVE REPLACEMENT INDICATOR (ERI) HAS BEEN REACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY ADX SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1