BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY DR

    MDR report key: 1223883 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03417
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 17, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z2977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR COULD NOT BE INTERROGATED, AND A "PLEASE LOCATE DEVICE" MESSAGE APPEARED. THE PROGRAMMED PARAMETERS COULD BE SEEN, BUT MEASURED DATA COULD NOT BE RETRIEVED AND TESTS WERE NOT POSSIBLE. AT THE LAST INTERROGATION IN 2008, BATTERY DATA WAS 2.69 V, 8 UA, 6.6 K WITH AN ESTIMATED LONGEVITY OF 1.75 YEARS TO ELECTIVE REPLACEMENT INDICATOR. THE DEVICE WAS TO BE SCHEDULED FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5370 NA

    Patients

    Seq Age Sex Outcome Treatment
    1