BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENCY SR+

    MDR report key: 4143242 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05709
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    June 28, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    LWP
    PMA / PMN Number
    P880006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE PULSE GENERATOR EXHIBITED NO OUTPUT WHEN CONNECTED TO THE LEADS. THE DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31711 REGENCY SR+ LWP ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 2400L

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention