BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGENCY SR+

    MDR report key: 4202238 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05021
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 23, 2011
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    LWP
    PMA / PMN Number
    P880006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    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. EVALUATION DESCRIPTION: COMPLAINT COULD NOT BE CONFIRMED. REASON FOR THE REPORTED OUTPUT ANOMALY COULD NOT BE DETERMINED. NORMAL ELECTRICAL CHARACTERISTICS AND DEVICE FUNCTION WERE MEASURED THROUGH ALL MECHANICAL, ELECTRICAL, AND THERMAL STRESS TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT THE PULSE GENERATOR EXHIBITED AN OUTPUT ANOMALY RESULTING IN LACK OF CARDIAC PACING. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28379 REGENCY SR+ IMPLANTABLE PACEMAKER PULSE GENERATOR, LWP ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 2400L

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR