BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 3936168 · Received July 15, 2014

    Report

    Report Number
    2124215-2014-13792
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    November 6, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    A PORTION OF THIS PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. IF ANALYSIS IS COMPLETED ON THIS PRODUCT, THIS REPORT WILL BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) DURING ATRIAL FLUTTER ABLATION PROCEDURE. THIS LEAD WAS PROGRAMMED TO OFF-ELECTROCAUTERY MODE FOR VOO PACING. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THAT WHEN THE DEVICE IS IN ELECTROCAUTERY MODE AND SEE AN EXTERNAL POWER SOURCE, THE DEVICE PACES AT SUB THRESHOLD LEVELS. THE PATIENT WAS PACEMAKER DEPENDENT. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE INDICATED THAT LOC RESULTED IN GREATER THAN TWO SECONDS OF ASYSTOLE. THIS LEAD WAS RE-PROGRAMMED AND REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD WAS SURGICALLY ABANDONED DUE TO THE PREVIOUSLY REPORTED LOSS OF CAPTURE WITH ASYSTOLE. THIS LEAD WAS SEVERED AND A PORTION HAS BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412175 ENDOTAK RELIANCE G IMPLANTABLE LEAD NVY BOSTON SCIENTIFIC CORPORATION 0296 114738

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Hospitalization| R 1290| N160| 4087| 4554| 4088| 0296