BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANARUS VISICA TREATMENT SYSTEM

    MDR report key: 520141 · Received April 7, 2004

    Report

    Report Number
    3003515897-2004-00004
    Event Type
    Injury
    Date Received
    April 7, 2004
    Date of Event
    March 8, 2004
    Report Date
    April 7, 2004
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS TREATED WITH THE VISICA SYSTEM FOR A FIBROADENOMA. THE PROCEDURE WAS STARTED AND ABOUT 5 MINUTES, INTO THE FIRST FREEZE CYCLE, THE PATIENT REPORTED FEELING NAUSEOUS. THE PATIENT THEN FAINTED AND BEGAN TO SEIZE. THE PHYSICIAN MANAGED THEM WITH A JAW THRUST AND STERNAL RUB TO STIMULATE BREATHING. THE PATIENT REGAINED CONSCIOUSNESS WITHIN A MINUTE OF THE VASOVAGAL REACTION. THE VISICA PROCEDURE WAS ABORTED AND THE PATIENT WAS OBSERVED FOR THE NEXT 30 MINUTES. THEY WERE REPORTED TO BE FINE UPON RELEASE AND WERE REPORTED BY THE PHYSICIAN TO BE FINE AS OF 8 DAYS LATER. THE PHYSICIAN BELIEVED THE VASOVAGAL REACTION WAS DUE TO PATIENT ANXIETY AND NOT THE CRYOABLATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS VISICA TREATMENT SYSTEM CRYOABLATION SYSTEM GEH SANARUS MEDICAL, INC. VP0500 V031001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention