BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD? LITE

    MDR report key: 3242874 · Received July 23, 2013

    Report

    Report Number
    3005099803-2013-07781
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K122459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF SUTURE DETACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE VAGINAL SUPPORT SYSTEM WAS IMPLANTED ON (B)(6) 2013. DURING THE IMPLANTATION PROCEDURE, DIFFICULTY WAS EXPERIENCED FIRING THE SUTURE OF THE FIRST LEG ASSEMBLY THROUGH THE SACROSPINOUS LIGAMENT. UPON REMOVAL OF THE CAPIO DEVICE FROM THE PATIENT, IT WAS NOTED THAT A PIECE OF THE SUTURE, WITH THE NEEDLE AT THE END, HAD BROKEN OFF INTO THE CAPIO CAGE. THE PHYSICIAN TIED A STAND-ALONE CAPIO SUTURE TO THE LEG ASSEMBLY AND COMPLETED THE PLACEMENT THROUGH THE LIGAMENT. THERE WERE NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343094 UPHOLD? LITE MESH, SURGICAL, POLYMERIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068318170 ML00001410

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR