BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE SG

    MDR report key: 8805025 · Received July 18, 2019

    Report

    Report Number
    2124215-2019-14021
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    January 1, 2015
    Report Date
    July 18, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526531248
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT THE RV LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597037 ENDOTAK RELIANCE SG PERMANENT DEFIBRILLATOR ELECTRODES NVY BOSTON SCIENTIFIC CORPORATION 0292 315953 00802526531248

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R