BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEA MED PACING SYSTEM ANALYZER

    MDR report key: 150197 · Received February 19, 1998

    Report

    Report Number
    150197
    Event Type
    Death
    Date Received
    February 19, 1998
    Date of Event
    February 11, 1998
    Report Date
    February 17, 1998
    Manufacturer
    SEA MED CORP.
    Product Code
    DTC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    2/2/98: PACEMAKER REVISION. VERY HIGH THRESHOLDS THOUGHT TO BE DUE TO SCARRING OF PT TISSUES. VENTRICULAR LEAD RUPTURED PAPILLARY MUSCLE OF TRICUSPID VALVE. PT UNDERWENT EMERGENT TRICUSPID VALVE REPLACEMENT. SUFFERRED FATAL COMPLICATIONS. WHEN SAME PACEMAKER ANALYZER WAS ABOUT TO BE USED ON ANOTHER PT, NOTED VERY ABERRANT READOUTS. REMEMBERED PRIOR CASE AND FELT THAT THIS MAY HAVE CAUSED OR CONTRIBUTED TO PT STATUS (2/11/98). EXPIRED 2/13/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEA MED PACING SYSTEM ANALYZER PACING SYSTEM ANALYZER DTC SEA MED CORP. 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death