BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY AFX

    MDR report key: 1896168 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05275
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    April 16, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND A LOSS OF ELECTRICAL CONTACT BETWEEN TWO OF THE RESISTORS AND THE HYBRID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR WOULD NOT GIVE BATTERY IMPEDANCE READINGS, ONLY DASHES. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY AFX IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5346 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention