BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 298376 · Received September 27, 2000

    Report

    Report Number
    298376
    Event Type
    Injury
    Date Received
    September 27, 2000
    Date of Event
    September 7, 2000
    Report Date
    September 27, 2000
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 09/04/2000 THE PT RECEIVED TWO (2) INAPPROPRIATE SHOCKS FOR LEAD NOISE WHILE SLEEPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC VENTRICULAR LEAD DTB MEDTRONIC, INC. 6945-65CM *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R