BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053338 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05713
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM REMAINS IN SERVICE AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND ONE INAPPROPRIATE SHOCK. NOISE WAS NOTED AND A CHECK LEAD MESSAGE WAS REPORTED DUE TO SUSPECTED LOW SENSING MEASUREMENTS. SHOCKING AND PACING IMPEDANCE MEASUREMENTS WERE STABLE AND WITHIN NORMAL LIMITS AND THRESHOLDS WERE ALSO GOOD. AN X-RAY REVEALED THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SUCCESSFULLY REPOSITIONED. IT WAS ALSO NOTED THE IT APPEARED AS THOUGH THE SUTURE THAT HAD ANCHORED THE DEVICE DOWN WAS BROKEN AND THE DEVICE WAS UPSIDE DOWN FROM HOW THE PHYSICIAN WOULD TYPICALLY ORIENT THE DEVICE. THE TIE DOWN ITSELF WAS INTACT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156416 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L 0292| E160