BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY ADX DR

    MDR report key: 1896703 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05305
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 27, 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
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT TELEMETRY WAS LOST WHEN THE BATTERY VOLTAGE WAS AT 2.5 V. THIS WAS DUE TO A DISCREPANT INTEGRATED CIRCUIT. AFTER REPLACING THE INTEGRATED CIRCUIT, NORMAL FUNCTION ENSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR COULD NOT BE INTERROGATED. ON (B)(6) 2010 THE BATTERY DATA WAS AT 2.68 V, 17 UA, AN 8 K. THE ESTIMATED LONGEVITY WAS AT 0.5 YEARS. THE DEVICE WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention