BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE SYSTEM

    MDR report key: 20561397 · Received October 29, 2024

    Report

    Report Number
    2124215-2024-67026
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    September 30, 2024
    Report Date
    October 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: PATIENT CODE E060101 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ASYSTOLE. PATIENT CODE E060106 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF HEART BLOCK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A HYDROGEL PLACEMENT EXPERIENCED A SERIOUS SYSTOLE. DURING THE PROCEDURE THE PATIENT EXPERIENCED 10 SECONDS OF VENTRICULAR STANDSTILL WHICH RESOLVED SPONTANEOUSLY. THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. CARDIOLOGY REVIEWED THE OVERNIGHT TELEMETRY, WHICH SHOWED INTERMITTENT WENCKEBACH ATRIAL TACHYCARDIA AND A PROLONGED PR INTERVAL (FIRST-DEGREE AV BLOCK). THE PATIENT REMAINED ASYMPTOMATIC AND HAS NO HISTORY OF PRESYNCOPE OR SYNCOPE. THE PATIENT HAS A HISTORY OF SEVERE CORONARY ARTERY CALCIFICATION AND MODERATE CALCIFIC AORTIC STENOSIS AND IS UNDER REGULAR SURVEILLANCE BY A CARDIOLOGIST. THE DEVICE REMAINS IMPLANTED, AND THE PATIENT WAS DISCHARGED AFTER HIS CONDITION WAS STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339680 SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-1010 0033106339

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other| H