BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPI

    MDR report key: 97517 · Received June 12, 1997

    Report

    Report Number
    97517
    Event Type
    Injury
    Date Received
    June 12, 1997
    Date of Event
    March 15, 1997
    Report Date
    March 25, 1997
    Manufacturer
    CPI--CARDIAC PACEMAKER, INC.
    Product Code
    DXY
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    10 Y/O PT WITH PACEMAKER EXCHANGED DUE TO END OF LIFE. NEW VIGOR #1230 INSERTED 3/6/97. PT FELT LIGHTHEADED WENT TO OUTSIDE HOSPITAL, SENT TO USER FACILITY. 3/15/97--4285 REMOVED LEAD WITH TINES; 3/15/97--4269 SCREW IN TYPE INSERTED. ARTERIAL LEAD DISLODGED QUICKLY (A FEW HRS) VENTRICULAR LEAD WITHIN ONE WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPI Implant PACEMAKER DXY CPI--CARDIAC PACEMAKER, INC. 1230--VIGOR DDD GENERATOR *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention