BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUARTET

    MDR report key: 8662410 · Received June 3, 2019

    Report

    Report Number
    2017865-2019-08836
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 22, 2019
    Report Date
    August 20, 2019
    Manufacturer
    ABBOTT
    Product Code
    OJX
    UDI-DI
    05414734503198
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    DURING THE IMPLANT PROCEDURE, THE SUTURE SLEEVE OF THE LEFT VENTRICULAR LEAD WAS DAMAGED. IT WAS ALLEGED THAT THE SLEEVE WAS TOO THIN. THE LEAD WAS IMPLANTED USING A DIFFERENT SUTURE SLEEVE AND THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455081 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ABBOTT 1458Q/86 S000068476 05414734503198

    Patients

    Seq Age Sex Outcome Treatment
    1