BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC, INC.

    MDR report key: 219814 · Received April 19, 1999

    Report

    Report Number
    219814
    Event Type
    Injury
    Date Received
    April 19, 1999
    Date of Event
    November 23, 1998
    Report Date
    April 16, 1999
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD DECREASED VENTRICULAR THRESHOLD. BECAUSE SHE WAS TOTALLY PACEMAKER DEPENDENT, ELECTRODE REMOVED AND NEW ONE PLACED. PHYSICIAN UNSURE IF PRODUCT WAS DEFECTIVE. PACEMAKER AND V-LEAD REPLACED, PT C/O SYNCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC. Implant PULSE GENERATOR DXY MEDTRONIC, INC. 8942 *
    2 MEDTRONIC, INC. Implant V LEAD DTB MEDTRONIC, INC. 4024-58 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention