BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLID GEL MFE, ADULT

    MDR report key: 222222 · Received May 5, 1999

    Report

    Report Number
    1220908-1999-00342
    Event Type
    Death
    Date Received
    May 5, 1999
    Report Date
    April 7, 1999
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE EMERGENCY ROOM PHYSICIAN WAS ATTEMPTING TO PACE A PT (AGE AND GENDER UNKNOWN) WHO WAS IN A CODE SITUATION. THE PT HAD BEEN DOWN FOR SOME LENGTH OF TIME WHEN PACING WAS INITIATED. ALTHOUGH THERE WERE PACING MARKS SHOWN ON THE DEVICE SCREEN, THE PT DID NOT APPEAR TO BE RECEIVING THE PACING PULSES, AS THERE WAS NO CHEST WALL OR THORACIC ACTIVITY. THE PT SUBSEQUENTLY EXPIRED, BUT THE COMPLAINANT INDICATED THAT THE PT OUTCOME WAS NOT AS A RESULT OF THE REPORTED MALFUNCTION AS THE PT HAD BEEN DOWN FOR SOME TIME PRIOR TO BEING PACED. PLEASE REFERENCE MEDWATCH NUMBERS 1220908-1999-00357 AND 1220908-1999-358, WHICH DOCUMENT TWO DIFFERENT AND SUBSEQUENT EVENTS THAT OCCURRED WITH ELECTRODES FROM THE SAME MULTI-FUNCTION ELECTRODE LOT NUMBER OF 5198, BUT THAT WERE BEING USED ON DIFFERENT PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLID GEL MFE, ADULT Implant DEFIB/PACING ELECTRODE MLN ZOLL MEDICAL CORP. 89004000 5198

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death