BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPI VENTAR MINI ICD

    MDR report key: 125277 · Received September 16, 1997

    Report

    Report Number
    125277
    Event Type
    Injury
    Date Received
    September 16, 1997
    Date of Event
    September 9, 1997
    Report Date
    September 15, 1997
    Manufacturer
    C.P.I. INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ICD IMPLANTED ON 8/26/97 FOR SLOW V-TACH. STRESS TEST PERFORMED ON 9/9/97. MAGNET APPLIED TO ICD DURING TEST TO TURN OFF DEVICE. FOLLOWING THE TEST IT WAS NOTED THAT DEVICE WAS CONTINUOUSLY BEEPING AND WAS BLINDED TO TACHYCARDIA. DESPITE MULTIPLE MAGNET MANEUVERS DEVICE COULD NOT BE RE-PROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPI VENTAR MINI ICD Implant IMPLANTABLE DEFIBRILLATOR LWS C.P.I. INC. 1742 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R