BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIPOTAR CONNECTOR

    MDR report key: 608184 · Received February 7, 2005

    Report

    Report Number
    MW4003940
    Event Type
    Injury
    Date Received
    February 7, 2005
    Date of Event
    December 21, 2004
    Report Date
    February 7, 2005
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    ---
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT UPGRADE OF ICD IN 2004 FOR A RE-SYNCHRONIZATION ICD. IN NOV. 2004 HE STARTED FEELING PERKINS IN HIR LEFT CHEST. CXR DEMONSTRATED FRACTURE IF LEAD. TESTING WAS PERFORMED IN PHYSICIAN OFFICE REQUIRED REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIPOTAR CONNECTOR LEAD DEVICE CARDIAC --- MEDTRONIC, INC. 4193-88 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention