BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EECP THERAPY SYSTEM, MODEL TS3

    MDR report key: 435257 · Received December 30, 2002

    Report

    Report Number
    MW1027082
    Event Type
    Injury
    Date Received
    December 30, 2002
    Report Date
    December 24, 2002
    Manufacturer
    VASOMEDICAL, INC.
    Product Code
    DRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT WAS TREATED WITH EITHER A DEVICE IDENTIFIED AS THE EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERA K020857 OR THE EECP THERAPY SYSTEM, MODEL TS3 K093469, MARKETED BY VASOMEDICAL, INC. THE DEVICE IS USED TO TREAT ANGINA, CHEST PAINS CAUSED BY RESTRICTED BLOOD FLOW IN THE CORONARY ARTERIES. CONSUMER WAS TREATED WITH THIS DEVICE DAILY FOR ABOUT THIRTY-FIVE DAYS. THE TREATMENT ALLEGEDLY RESULTED IN DAMAGE TO THEIR EYE RESULTING IN RETINAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EECP THERAPY SYSTEM, MODEL TS3 EXTERNAL CONTER-PULSATING DEVICE DRN VASOMEDICAL, INC. TS3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention