BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 15306460 · Received August 26, 2022

    Report

    Report Number
    2124215-2022-32847
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    August 8, 2022
    Report Date
    September 22, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526531125
    PMA / PMN Number
    P910073/S039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACE/SENSE PORTION OF THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED. A DIFFERENT IMPLANTED RV LEAD IS USED FOR THE PACING/SENSING. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACE/SENSE PORTION OF THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED. A DIFFERENT IMPLANTED RV LEAD IS USED FOR THE PACING/SENSING. ADDITIONAL INFORMATION FROM THE FIELD INDICATED THAT IT WAS THE PHYSICIAN'S PREFERENCE TO USE THE CHRONIC RV LEAD FOR THE PACE/SENSE OF THE SYSTEM. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356863 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0157 303714 00802526531125

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization| R