BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS H5000

    MDR report key: 4489610 · Received September 30, 2014

    Report

    Report Number
    4489610
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 30, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRITICAL FAILURE OF CINE DURING A BIV ICD IMPLANT ON PATIENT, THE CINE FAILED DURING ATTEMPT TO PERFORM CORONARY SINUS (CS) ANGIOGRAM. CLINICAL ENGINEERING CONTACTED AND WAS UNABLE TO FIX. PHYSICIAN FORCED TO IMPROVISE MID-SURGERY TO LOCATE APPROPRIATE CS BRANCH FOR LEAD PLACEMENT. NO INJURY NOTED TO PATIENT. PROCEDURE PROLONGED DUE TO DELAY AND INCREASED DIFFICULTY OF CS LEAD PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609657 INTEGRIS H5000 SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS, INC. 0038940 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *