BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 437971 · Received December 30, 2002

    Report

    Report Number
    437971
    Event Type
    Injury
    Date Received
    December 30, 2002
    Date of Event
    October 7, 2002
    Report Date
    November 22, 2002
    Manufacturer
    METRONIC, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    LEAD FRACTURE DETECTED BY DEVICE SELF-TESTING. PT HOSPITALIZED AND LEAD REPLACED. OLD LEAD CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC DEFIBRILLATOR LEAD LWS METRONIC, INC. 6966 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization