BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE SYSTEM

    MDR report key: 19160992 · Received April 22, 2024

    Report

    Report Number
    2124215-2024-24005
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    April 5, 2024
    Report Date
    April 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00864661000140
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF PATIENT CODE E0112 CAPTURES THE REPORTABLE EVENT OF DIZZINESS. IMDRF PATIENT CODE E233001 CAPTURES THE REPORTABLE EVENT OF CHEST PAIN. IMDRF PATIENT CODE E2320 CAPTURES THE REPORTABLE EVENT OF HIGH BLOOD PRESSURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR VUE DEVICE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS NOTED TO HAVE GONE WELL. AFTER THE PROCEDURE THE PATIENT STARTED FEELING LIGHTHEADED AND EXPERIENCED CHEST PAIN. IT WAS ALSO NOTED THAT THE PATIENT'S BLOOD PRESSURE WAS HIGH. THE PROCEDURE WAS PERFORMED WITH LOCAL ANESTHESIA. DUE TO THE PATIENT'S SYMPTOMS THE PHYSICIAN THOUGHT THAT THE PATIENT WAS EXPERIENCING A VASOVAGAL RESPONSE AND DECIDED TO CALL AN AMBULANCE. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL, WHERE HE WAS DISCHARGED IMMEDIATELY BECAUSE HIS BLOOD PRESSURE WENT BACK TO NORMAL, AND THE CHEST PAIN SUBSIDED. NO MEDICAL TREATMENT WAS PROVIDED DUE TO THIS EVENT. THE EVENT WAS REPORTED AS RESOLVED SINCE THE PATIENT'S SYMPTOMS IMPROVED AND HIS CONDITION WENT BACK TO NORMAL BY THE TIME HE WAS CHECKED INTO THE EMERGENCY DEPARTMENT (ED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075906 SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101 00864661000140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention