BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM

    MDR report key: 1234096 · Received November 4, 2008

    Report

    Report Number
    3005099803-2008-05937
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K990295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. BSC REF: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2008, THAT A PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM WAS USED DURING A VAGINAL SLING PROCEDURE ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND WITH THE DEVICE OUTSIDE OF THE PT, IT MISFIRED. PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PT'S CONDITION WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM MBI BOSTON SCIENTIFIC CORPORATION M0068201550 12016339

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK