BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EECP

    MDR report key: 293506 · Received August 30, 2000

    Report

    Report Number
    2435300-2000-00002
    Event Type
    Injury
    Date Received
    August 30, 2000
    Date of Event
    July 13, 2000
    Report Date
    August 29, 2000
    Manufacturer
    VAMED MEDICAL INSTRUMENTS CO. LTD
    Product Code
    DRN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT NOTED TO BE SHORT OF BREATH (SOB) & SOMEWHAT ANXIOUS UPON PRESENTATION FOR PT'S FIRST EECP TREATMENT. AFTER ONLY ABOUT 5 MINS. OF TREATMENT THE PT COMPLAINED OF INCREASED SOB & ANXIETY. PT'S HEART RATE WAS ALSO INCREASED. AFTER 12 MINS. THE TREATMENT WAS STOPPED DUE TO WORSENING SOB AND TACHYCARDIA. PT WAS GIVEN OXYGEN & AN AMBULANCE WAS CALLED. THE PT WAS TRANSPORTED TO A HOSP FOR EMERGENCY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EECP EXTERNAL COUNTERPULSATING DRN VAMED MEDICAL INSTRUMENTS CO. LTD MC2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization NITROGLYCERIN SPRAY, LIPITOR, PRINIVIL, GLUCOPHAGE| GLYBURIDE.