BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE PACING CABLES

    MDR report key: 3516515 · Received December 6, 2013

    Report

    Report Number
    3516515
    Event Type
    Malfunction
    Date Received
    December 6, 2013
    Date of Event
    August 22, 2013
    Report Date
    November 7, 2013
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    REMINGTON PACING CABLES FL-601-97 LOT #'S 131262 AND 131021 WERE OPENED FOR USE. THE PLASTIC GRIPS WOULD NOT OPEN ENOUGH TO ACCEPT PACING WIRE POST. NO ALTERNATIVE. SURGEON WAS ABLE TO FINALLY GET PACING WIRE POST INTO GRIP AFTER CONSIDERABLE MANIPULATION AND EFFORT. VALUE ANALYSIS TEAM NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633778 DISPOSABLE PACING CABLES CABLE, TRANSDUCER AND ELECTRODE, PATIENT DSA REMINGTON MEDICAL, INC. N/A 131262
    633779 DISPOSABLE PACING CABLES CABLE, TRANSDUCER AND ELECTRODE, PATIENT DSA REMINGTON MEDICAL, INC. N/A 131021

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO