BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBI¿ 1400-CV CARDIOVERSION II SWITCH BOX

    MDR report key: 8315917 · Received February 7, 2019

    Report

    Report Number
    2030404-2019-00008
    Event Type
    Injury
    Date Received
    February 7, 2019
    Date of Event
    January 14, 2019
    Report Date
    April 5, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MTE
    PMA / PMN Number
    P020052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CARDIOVERSION II SWITCH BOX WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION IT WAS CONFIRMED THE DEVICE WAS DAMAGED AND HAD BROKEN SWITCHES. FUNCTIONAL TESTING COULD NOT BE PERFORMED AS THE SWITCHES WOULD NOT TURN MAKING THE DEVICE NONFUNCTIONAL. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES. THE REPORTED INABILITY TO DELIVER ELECTRIC SHOCK AND SUBSEQUENT PROCEDURE CANCELLATION COULD NOT BE CONFIRMED AS THE DEVICE COULD NOT BE TESTED IN THE CONDITION RECEIVED.

    Description of Event or Problem · 1

    DURING AN ELECTROPHYSIOLOGY PROCEDURE, A CANCELLATION OCCURRED DUE TO THE INABILITY TO DELIVER ELECTRIC SHOCK. THE ISSUE COULD NOT BE RESOLVED AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111452 IBI¿ 1400-CV CARDIOVERSION II SWITCH BOX SYSTEM, PACING, TEMPORARY, ACUTE, INTERNAL ATRIAL DEFIBRILLATION MTE ST. JUDE MEDICAL, INC. 85432

    Patients

    Seq Age Sex Outcome Treatment
    1 Other