BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY DR

    MDR report key: 1050964 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01318
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 21, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMAP880086
    Removal / Correction Number
    Z2977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 MEASURED BATTERY DATA WAS LOST WHEN THE BATTERY VOLTAGE WAS REDUCED TO 2.40 V. THIS WAS CAUSED BY A DISCREPANT INTERGRATED CIRCUIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC DUE TO BEING SYMPTOMATIC. AN INTERROGATION REVEALED AN ERROR MESSAGE. MEASURED DATA ONE WEEK PREVIOUS WAS 2.72 V, 10 UA, AND 11.1 KOHMS WITH AN ESTIMATED .75 YEARS REMAINING LONG- EVITY. COMMUNICATION WAS LOST DURING A THRESHOLD TEST ATTEMPT.

    Description of Event or Problem · 1

    .

    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