BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC INC

    MDR report key: 122078 · Received September 4, 1997

    Report

    Report Number
    122078
    Event Type
    Malfunction
    Date Received
    September 4, 1997
    Date of Event
    July 3, 1997
    Report Date
    September 4, 1997
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INAPPROPRIATE SHOCKS FROM OVERSENSING OF A 6936 UMPLANTABLE TACHYCARDIA LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INC IMPLANTABLE TACHYCARDIAL LEAD LWS MEDTRONIC, INC. TAV006842R *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other