BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES

    MDR report key: 298645 · Received September 26, 2000

    Report

    Report Number
    3015876-2000-00445
    Event Type
    Malfunction
    Date Received
    September 26, 2000
    Report Date
    September 20, 2000
    Manufacturer
    MEDTRONIC PHYSIO-CONTROL CORP.
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MEDWATCH REPORT WAS RECEIVED WITH THE FOLLOWING EVENT DESCRIPTION: THE MEDTRONIC PHYSIO-CONTROL EDGE SYSTEM FAST PATCH PLUS PACKAGES (3010188-007 AND 3010188-06) ARE VERY SIMILAR TO THE QUICK-COMBO PACKAGES (3010188-005). THESE TWO DIFFERENT UNITS, HOWEVER ARE TOTALLY INCOMPATIBLE. THESE UNITS ARE USED WITH DEFIBRILLATORS. A MIXUP COULD RESULT IN SIGNIFICANT DELAY IN DEFIBRILLATION, RESULTING IN ADVERSE PT OUTCOME. BETTER IDENTIFICATION NEEDS TO BE DEVISED FOR THE PACKAGING IN WHICH THESE UNITS ARE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES MLN MEDTRONIC PHYSIO-CONTROL CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA