BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 20244731 · Received September 18, 2024

    Report

    Report Number
    2124215-2024-58255
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    August 20, 2024
    Report Date
    April 15, 2026
    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
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO FIELD F10. DEVICE CODES. THIS SUPPLEMENTAL CORRECTION REPORT WAS CREATED TO CAPTURE UPDATES ON D2A: COMMON DEVICE NAME.

    Additional Manufacturer Narrative · 0

    CORRECTION TO FIELD F10. DEVICE CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD PACE/SENSE PART WAS SURGICALLY CAPPED. FURTHERMORE, THE OTHER RV LEAD WAS USED FOR PACING AND SENSING. THIS LEAD REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD PACE/SENSE PART WAS SURGICALLY CAPPED. FURTHERMORE, THE OTHER RV LEAD WAS USED FOR PACING AND SENSING. THIS LEAD REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD INDICATING THAT THIS LEAD PACE/SENSE PART WAS SURGICALLY ABANDONED AS THIS IS A STANDARD OPERATING PROCEDURE FOR THIS ELECTROPHYSIOLOGY AT UPGRADES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD PACE/SENSE PART WAS SURGICALLY CAPPED. FURTHERMORE, THE OTHER RV LEAD WAS USED FOR PACING AND SENSING. THIS LEAD REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD INDICATING THAT THIS LEAD PACE/SENSE PART WAS SURGICALLY ABANDONED AS THIS IS A STANDARD OPERATING PROCEDURE FOR THIS ELECTROPHYSIOLOGY AT UPGRADES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573915 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0157 303727 00802526531125

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention| H