BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGENCY SCX

    MDR report key: 10643481 · Received October 7, 2020

    Report

    Report Number
    2017865-2020-14974
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 18, 2020
    Report Date
    October 7, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P880006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI NOT AVAILABLE AS PRODUCT WAS MANUFACTURED ON OR BEFORE 23 SEP 2014. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACING DEPENDENT PATIENT PRESENTED FOR IN-CLINIC FOLLOW UP WITH THE PULSE GENERATOR UNABLE TO DISPLAY BATTERY DATA. IT WAS NOTED THAT THE MAGNET RATE WAS ABOVE THE ELECTIVE REPLACEMENT INDICATOR THRESHOLD, HOWEVER BATTERY LONGEVITY ESTIMATES WERE UNOBTAINABLE. THERE WERE NO INTERVENTIONS WERE REPORTED. THE PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106199 REGENCY SCX IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2408L 2979158

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR