BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY SR

    MDR report key: 2240031 · Received September 8, 2011

    Report

    Report Number
    2017865-2011-05874
    Event Type
    Injury
    Date Received
    September 8, 2011
    Date of Event
    July 20, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Removal / Correction Number
    Z2977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE PULSE GENERATOR TO BE IN BACK-UP MODE. THE BATTERY WAS AT END-OF-LIFE (EOL) VOLTAGE LEVEL. AFTER REPLACING THE BATTERY, NORMAL FUNCTION ENSUED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR COULD NOT BE INTERROGATED. THE ESTIMATED REMAINING LONGEVITY OF THE BATTERY WAS 1.5 YEARS. THE DEVICE WAS REMOVED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention