BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTIFUNCTION ELECTRODE

    MDR report key: 22259 · Received May 22, 1995

    Report

    Report Number
    22259
    Event Type
    Other
    Date Received
    May 22, 1995
    Date of Event
    May 19, 1995
    Report Date
    May 22, 1995
    Manufacturer
    CARDIOTRONICS SYSTEM, INC.
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD MULTIFUNCTION ELECTRODE PAD PUT ON ON 5/19/95 AT APPROX 4:00 PM. PT HAD EPISODE OF V TACH AT 5:05 AM REQUIRING DEFIBRILLATION AT 200 JOULES AND AT 5:40 AM HAD ANOTHER EPISODE OF V TACH MULTIPLE RUNS, REQUIRING MULTIPLE DEFIB WITH 200 JOULES. PT THEN HAD SINUS RHYTHM AFTER DEFIB THEN RAPID A FIB AND WAS BEING STABILIZED. AT 8:00 AM THE PT WAS TURNED TO REPLACE PAD AND IT WAS DISCOVERED THAT THE RA (POSTERIOR) LEADWIRE HAD COME OUT FROM THE PAD CAUSING A BLISTERED BURN TO THE PT'S BACK 1.5 INCHES IN DIAMETER. A HOLE WAS ALSO NOTED IN THE PT'S BED LINEN, WHICH WAS BURNT FROM THE DISCONNECTED LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFUNCTION ELECTRODE MULTIFUNCTION ELECTRODE LDD CARDIOTRONICS SYSTEM, INC. R2 PAD

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other