BEUDAMED
    FDA Adverse Event Other Summary report: N

    CADENCE ZOLL ADULT RTS

    MDR report key: 2997565 · Received March 5, 2013

    Report

    Report Number
    1219103-2013-00004
    Event Type
    Other
    Date Received
    March 5, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS LUDLOW
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. 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)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH DEFIBRILLATION ELECTRODES. THE CUSTOMER REPORTS THE PATIENT RECEIVED CHEST BURNS FROM THE ELECTRODES. THE PATIENT WAS BURNED DURING AN ENDOSCOPY PROCEDURE, THE ELECTRODES WERE BEING USED FOR CARDIO VERSIONS. THE BURNS WERE NOTICED AFTER THE PROCEDURE. THE DOCTOR DESCRIBED THE BURNS AS SECOND DEGREE, AND PRESCRIBED SILVADENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94014 CADENCE ZOLL ADULT RTS DEFIBRILLATION ELECTRODES MLN COVIDIEN LP, FORMERLY REGISTERED AS LUDLOW 22770R 230057

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other