BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE SYSTEM FOR USE WITH FAST-PATCH PLUS

    MDR report key: 283433 · Received June 23, 2000

    Report

    Report Number
    3015876-2000-00307
    Event Type
    Malfunction
    Date Received
    June 23, 2000
    Date of Event
    May 24, 2000
    Report Date
    May 25, 2000
    Manufacturer
    MEDTRONIC PHYSIO-CONTROL CORP.
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SET OF DISPOSABLE ELECTRODES REPORTEDLY WOULD NOT REMAIN ADHERED TO A PT DURING A PROCEDURE IN THE FACILITY'S CARDIAC CATH LAB. THE PT'S OUTCOME AND DETAILS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDGE SYSTEM FOR USE WITH FAST-PATCH PLUS ELECTRODES DRX MEDTRONIC PHYSIO-CONTROL CORP. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN