BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 400 SERIES

    MDR report key: 268965 · Received March 13, 2000

    Report

    Report Number
    MW1018384
    Event Type
    Injury
    Date Received
    March 13, 2000
    Date of Event
    September 8, 1998
    Report Date
    March 13, 2000
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT WAS IN PERFECT HEALTH. PT WAS IMPLANTED WITH DEVICE BECAUSE OF BRADYCARDIA AS LOW AS 26. AFTER IMPLANTATION, THE PT HAS HAD CHEST PAIN AND MANY OTHER MEDICAL PROBLEMS INCLUDING PANCREATITIS, LIVER DISEASE AND LUNG DISEASE THAT WORSENED FROM INITIAL DIFFICULTY POST RETURN FROM OVERSEAS. PT WAS PLACED ON A MONITOR THAT DOCUMENTED CHEST PAIN EPISODE. RPTR HAS SEEN AN ALERT FROM FDA THAT STATES THAT PACEMAKERS CAN BE INTERFERED WITH BY SOURCES SUCH AS MONITORS, ECHOCARDIOGRAMS, CELLPHONES, CAR ALARMS AND DIAGNOSTIC EQUIPMENT. NEITHER THE MFR OR PT'S DR NOTIFIED PT OF THIS ALERT. PT IS STILL HAVING CHEST PAINS ESPECIALLY WHEN AROUND ELECTRICAL DEVICES. PT HAS HAD MANY VISITS TO THE HOSP BECAUSE OF HEALTH PROBLEMS INCLUDING THE CHEST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 400 SERIES PACEMAKER/LEADS DXY MEDTRONIC, INC. KDR 401 NA
    2 KAPPA 400 SERIES PACEMAKER/LEADS DTB MEDTRONIC, INC. 456845 NA
    3 KAPPA 400 SERIES PACEMAKER/LEADS DTB MEDTRONIC, INC. 4058M52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| L| O| R| S