BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 2276052 · Received September 28, 2011

    Report

    Report Number
    MW5022465
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    September 23, 2011
    Report Date
    September 28, 2011
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NO PT HARM. CARTO SYSTEM WOULD NOT WORK. COULD NOT USE THE CATHETER AND PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER REF PATCH OBJ XRPP8Y 15363030L
    2 BIOSENSE WEBSTER CATHETER OBJ 34J57M 154337

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR