BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE 4-FRONT

    MDR report key: 8250494 · Received January 15, 2019

    Report

    Report Number
    2124215-2018-62886
    Event Type
    Injury
    Date Received
    January 15, 2019
    Date of Event
    December 7, 2018
    Report Date
    January 15, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 ONE DAY POST IMPLANT, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED THRESHOLD MEASUREMENTS AND THE PATIENT WAS EXPERIENCING HICCUPPING SENSATIONS DURING BI-VENTRICULAR TRIGGER PACING. THE IMPEDANCE AND SENSING MEASUREMENTS ARE STABLE AND WITHIN NORMAL LIMITS. AN X-RAY WAS ORDER TO ASSESS FOR POSSIBLE PERFORATION OR DISLODGEMENT. X-RAY RESULTS SHOWED THAT THERE WAS A LOSS OF SLACK IN THE LEAD AND A MICRO-DISLODGEMENT WAS SUSPECTED. SURGICAL INTERVENTION WAS PERFORMED AND THE LEAD WAS REPOSITIONED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43103 RELIANCE 4-FRONT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0693 526557

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R