BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC PACEMAKERS, INC

    MDR report key: 121016 · Received September 16, 1997

    Report

    Report Number
    121016
    Event Type
    Malfunction
    Date Received
    September 16, 1997
    Date of Event
    August 8, 1997
    Report Date
    August 20, 1997
    Manufacturer
    CARDIAC PACEMAKERS, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD CARDIOVERTER DEFIBRILLATOR PLACED. THE PT COMPLAINED OF FREQUENT "SHOCK" FROM THE DEVICE. THE DEVICE WAS REMOVED AND THE INTRACARDIAC ELECTRODES DEMONSTRATED OVERSENSING FROM BT10 LEAD CAUSING INAPPROPRIATE ICD SHOCKS TO THE PT. NO PROBLEM WITH THE INTERMEDICS ICD WAS FOUND, ALTHOUGH THESE WERE REMOVED AND REPLACED WITH A DIFFERENT INTERMEDICS ICD WHEN THE SYSTEM WAS MOVED FROM THE ABDOMINAL TO THE PECTORAL POSITION. PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC PACEMAKERS, INC CPI-BT10 LWS CARDIAC PACEMAKERS, INC. BT10 *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other