BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPICARDIAL PACING- DISPOSABLE SCREW DOWN EXTENSION CABLES

    MDR report key: 16513294 · Received March 8, 2023

    Report

    Report Number
    MW5115599
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 21, 2023
    Report Date
    March 6, 2023
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A TEMPORARY PACEMAKER, AND DISLODGE THE CABLES FROM THE PACER BOX. WHEN THE CABLES WERE TESTED, THEY DID NOT CLICK INTO A LOCK POSITION DUE TO A DEFECT. THE CABLES WERE REPLACED. A 55 YEAR OLD MALE UNDERWENT DOUBLE VALVE AND CORONARY ARTERY BYPASS (B)(6) 2023. TWO TEMPORARY RIGHT VENTRICULAR PACER WIRES WERE IN PLACED, AND CONNECTED TO TEMPORARY PACER BOX AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140215 EPICARDIAL PACING- DISPOSABLE SCREW DOWN EXTENSION CABLES CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) DSA REMINGTON MEDICAL, INC. FL-601-97 2222043

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male