BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY ADX DR

    MDR report key: 2014015 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01733
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 30, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND NO OUTPUT OR TELEMETRY DURING INTERROGATION. THE DEVICE WAS AT END-OF-LIFE (EOL) DUE TO NORMAL BATTERY DEPLETION. 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 A SYMPTOMATIC PATIENT PRESENTED IN THE EMERGENCY ROOM IN BACK-UP VVI MODE. THE PATIENT HAD BEEN LOST TO FOLLOW-UP. THE PULSE GENERATOR WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY ADX DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5360 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention