BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY SR

    MDR report key: 1011154 · Received March 10, 2008

    Report

    Report Number
    2017865-2008-00654
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    December 18, 2007
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    Z2977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE PULSE GENERATOR WAS UNABLE TO INTERROGATE BELOW 2.40 V, DUE TO A DISCREPANT INTEGRATED CIRCUIT. THE DEVICE BATTERY VOLTAGE DROPPED BELOW END-OF-LIFE (EOL) RESULTING IN LOSS OF OUTPUT AND TELEMETRY. AFTER REPLACING THE BATTERY, NORMAL FUNCTION ENSUED. THE PULSE GENERATOR WAS RECEIVED APPROXIMATELY 2 YEARS AFTER EXPLANT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, SEASPINE WAS INFORMED THAT THIS PATIENT RECEIVED A REVISION SURGERY ON (B)(6)2010. THE REVISION WAS DONE DUE TO PATIENT DISCOMFORT. THE X-RAY REVEALED A POTENTIAL BROKEN CLIP. ALL HARDWARE WAS REMOVED BUT THE ALLOGRAFT WAS NOT.

    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 * Required Intervention