BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT HEART CURVE BALLOON

    MDR report key: 85290 · Received April 17, 1997

    Report

    Report Number
    1217435-1997-00123
    Event Type
    Malfunction
    Date Received
    April 17, 1997
    Report Date
    March 21, 1997
    Manufacturer
    CR BARD GLENS FALLS
    Product Code
    LDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO CO THAT DURING THE PROCEDURE THIS DEVICE FAILED TO PACE. THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGHT HEART CURVE BALLOON ELECTRODE CATHETER LDF CR BARD GLENS FALLS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN