BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY DR

    MDR report key: 4152192 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-06327
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    November 28, 2011
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. FINAL ANALYSIS COULD NOT CONFIRM THE LOSS OF OUTPUT. THE DEVICE PASSED ALL TESTS AND NORMAL BATTERY DEPLETION WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GENERATOR CHANGE THE DEVICE WAS EXPOSED TO ELECTROCAUTERY. BOTH PACING AND TELEMETRY WERE NOT POSSIBLE AFTER THIS OCCURRED. THE DEVICE WAS EXPLANTED AND RETURNED TO SJM FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23112 INTEGRITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 5366

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention