BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE 4-FRONT

    MDR report key: 9540841 · Received January 2, 2020

    Report

    Report Number
    2124215-2019-23600
    Event Type
    Injury
    Date Received
    January 2, 2020
    Date of Event
    September 1, 2019
    Report Date
    January 2, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526592867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    IWR;IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF AN INFECTION. A DRAINAGE AND MEDICAL INTERVENTION WERE PERFORMED. THIS SYSTEM REMAINS IN SERVICE. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711 RELIANCE 4-FRONT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0673 106174 00802526592867

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R