BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY DR

    MDR report key: 1050472 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01273
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 12, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    Z2977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 MEASURED BATTERY DATA WAS 2.51 V, 7 UA, 29.2 KOHMS WITH A MAGNET RATE OF 86.3 PPM. A DEVICE IMAGE SHOWED THAT THE BATTERY IMPEDANCES OF 1-2 KOHMS AND THE BATTERY VOLTAGE OF 2.75 V HAD BEEN STEADY FOR MONTHS. IN 2007, THE MEASURED BATTERY DATA WAS 2.55 V, 15 UA, 2.2 KOHMS WITH AN ESTIMATED REMAINING LONGEVITY OF 2-2.5 YEARS.

    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 Required Intervention