BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY ADX DR

    MDR report key: 1896413 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05303
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    August 27, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THE PULSE GENERATOR COULD NOT BE INTERROGATED. THE MAGNET RATE WAS IN THE 90'S AND THE DEMAND RATED APPEARED TO BE 60 BPM, INDICATING THAT THE DEVICE HAD NOT REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). ON (B)(6) 2010 BATTERY DATA WAS 2.61 V, 16 UA, 10.3 KOHMS WITH A LONGEVITY OF SIX MONTHS TO ERI. THE DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY ADX DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5380 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention