BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY SR

    MDR report key: 1223797 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03481
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 29, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMAP880086
    Removal / Correction Number
    Z2977
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION THE MESSAGE - DATA NOT READ - APPEARED IN PLACE OF VALUES. IN 2008, MAGNET RATE WAS 96, BATTERY VOLTAGE WAS 2.72 V, AND THERE WAS AN ESTIMATED REMAINING LONGEVITY OF 9 MONTHS. REMEASURING AND RECALIBRATING DID NOT REVEAL ANY OTHER MEASUREMENTS. THE DEVICE IMAGE INDICATED THAT IT WAS NOT AT ELECTIVE REPLACEMENT INDICATOR. THE PULSE GENERATOR WAS TO BE DOWN- LOADED AT THE NEXT FOLLOW UP TO RESOLVE THE ERROR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5172 NA

    Patients

    Seq Age Sex Outcome Treatment
    1