BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADENCE PHYSION QC ADULT

    MDR report key: 3928313 · Received June 17, 2014

    Report

    Report Number
    1219103-2014-00017
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH DEFIBRILLATION ELECTRODES. THE CUSTOMER STATES THERE WAS INTERMITTENT LOSS OF EKG SIGNAL THROUGH THE DEFIBRILLATION ELECTRODE DURING A PROCEDURE IN THE CATH LAB. THE CUSTOMER REPORTS THAT MANIPULATING THE LEADWIRES OF THE DEFIBRILLATION ELECTRODES WOULD CAUSE THE SIGNAL TO CUT IN AND OUT. THE CUSTOMER FURTHER REPORTS THAT THE PROCEDURE WAS CARDIAC ABLATION, NO HARM AND NO OTHER INTERVENTION. THE PROBLEM OCCURRED IMMEDIATELY AFTER STANDARD INITIAL PLACEMENT. PATCHES WERE REPLACED WITHOUT A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355843 CADENCE PHYSION QC ADULT DEFIBRILLATION ELECTRODES MLN COVIDIEN 22550A 404315X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK