BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGENCY SCX

    MDR report key: 7712818 · Received July 23, 2018

    Report

    Report Number
    2017865-2018-10722
    Event Type
    Malfunction
    Date Received
    July 23, 2018
    Date of Event
    June 25, 2018
    Report Date
    July 23, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P880006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. UPON INTERROGATION, THE PACEMAKER EXHIBITED A DIAGNOSTICS ANOMALY AND DID NOT DISPLAY ANY LEAD OR BATTERY DATA NECESSARY FOR COMPLETING A LONGEVITY ESTIMATE. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554879 REGENCY SCX IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2408L

    Patients

    Seq Age Sex Outcome Treatment
    1