BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT CORP

    MDR report key: 309176 · Received December 15, 2000

    Report

    Report Number
    MW1020635
    Event Type
    Injury
    Date Received
    December 15, 2000
    Date of Event
    November 28, 2000
    Report Date
    December 1, 2000
    Manufacturer
    GUIDANT CORP.
    Product Code
    DXY
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GUIDANT PACEMAKER IMPLANTED. MONITORING (TELEPHONE) INDICATED A FRACTURED (BROKEN) LEAD WIRE. ELECTIVE LEAD REPLACEMENT PROCEDURE SCHEDULED AND PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT CORP PACEMAKER DXY GUIDANT CORP. 4451 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention