BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 273549 · Received April 7, 2000

    Report

    Report Number
    MW1018656
    Event Type
    Other
    Date Received
    April 7, 2000
    Date of Event
    August 4, 1999
    Report Date
    April 4, 2000
    Manufacturer
    CARDIAC PACEMAKERS, INC. GUIDANT CORP.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ENROLLED IN MADIT II STUDY. ONE DAY AFTER IMPLANT OF AICD, WHEN PT WAS RIDING HOME FROM HOSP. PT HAD NEAR SYNCOPAL EPISODE. PT WENT TO LOCAL MD WHO THEN CALLED 911. BP FOUND TO BE 80 SYSTOLIC. PT TAKEN TO ER AND HAD EKG, CXR, BLOOD WORK. PT TOLD THEY HAD GOTTEN DEHYDRATED. PT IMPLANTED WITH AICD. PT DISCHARGED TO HOME, CONDITION STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * LWS CARDIAC PACEMAKERS, INC. GUIDANT CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other