BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITY DR

    MDR report key: 4140015 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05919
    Event Type
    Injury
    Date Received
    January 13, 2014
    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
    SP
    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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS FOUND TO BE PROGRAMMED TO A DIFFERENT BASE RATE A DAY AFTER THE PT HAD PRESENTED IN CLINIC FOR A FOLLOW-UP. THE PT FELT FATIGUED DURING THAT TIME. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34394 AFFINITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR, LWP LWP ST. JUDE MEDICAL, INC. CRMD 5330

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention