BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SCREW-DOWN EXTENSION CABLE FOR PACEMAKERS

    MDR report key: 1245513 · Received November 9, 2008

    Report

    Report Number
    1245513
    Event Type
    Malfunction
    Date Received
    November 9, 2008
    Date of Event
    October 12, 2008
    Report Date
    November 9, 2008
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    LDF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTING TO ATTACH PATIENT PACING WIRES TO DISPOSABLE PACING CABLE DURING CODE. REPORTEDLY STAFF UNABLE TO SECURE PACING WIRES INTO CABLE END. TRIED 5 CABLES BEFORE SUCCESSFUL ATTACHMENT.MANUFACTURER RESPONSE FOR DISPOSABLE EXTENSION CABLE FOR PACEMAKERS: [A] MFR IS AWARE THAT THE CLEARANCE FOR THE PINS OUR FACILITY IS INSERTING INTO THEIR CONNECTOR IS ONLY .004 INCH. GIVEN THIS TIGHT TOLERANCE, THEIR CONNECTOR HAS TO BE UNSCREWED TO ITS MAXIMUM TO ACCEPT THIS PIN. [B] MFR UNDERSTANDS MOST CLINICAL USERS INSERT A KEITH NEEDLE DIRECTLY INTO THE CONNECTOR, VERSUS THE PINS OUR FACILITY IS USING. [C] MFR STATES THE KEITH NEEDLE TENDS TOWARDS THE MINIMUM DIAMETER FOR THEIR CONNECTOR, & THE PINS OUR FACILITY USES TEND TOWARDS THE MAXIMUM. MFR FEELS A CHANGE EITHER WAY IN THE CONNECTOR WOULD PREVENT SOMEONE FROM BEING ABLE TO USE THEIR PRODUCT, WHEREAS BOTH CURRENTLY WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SCREW-DOWN EXTENSION CABLE FOR PACEMAKERS CABLE, PACEMAKER EXTENSION LDF REMINGTON MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR