BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY AFX

    MDR report key: 3925507 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08671
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    November 7, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. 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 REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION: THE REPORTED BACKUP VVI WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A SINGLE BIT FLIP IN THE PRODUCT CODE. AFTER THE PRODUCT CODE WAS DOWNLOADED, NORMAL FUNCTION RESUMED. THE CAUSE OF THE SINGLE BIT FLIP COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW UP. THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38314 INTEGRITY AFX IMPLANTABLE PACEMAKER PULSE GENERATOR, LWP LWP ST. JUDE MEDICAL, INC., CRMD 5346

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention