BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1885227 · Received October 28, 2010

    Report

    Report Number
    3005099803-2010-04564
    Event Type
    Injury
    Date Received
    October 28, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE LOT# OF THE DEVICE IS UNKNOWN, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE. (B)(4) - NO INFORMATION IS AVAILABLE REGARDING WHAT OTHER "SERIOUS BODILY INJURIES" THE PATIENT HAS SUFFERED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PELVIC FLOOR RECONSTRUCTION PROCEDURE WAS PERFORMED ON (B)(6) 2009 USING AN UPHOLD VAGINAL SUPPORT SYSTEM VIA A VERTICAL INCISION TO TREAT UTERINE PROLAPSE AND URINARY INCONTINENCE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT PRESENTED WITH "SERIOUS BODILY INJURIES...INCLUDING VAGINAL AND PELVIC PAIN, AND CONTINUED URINARY INCONTINENCE". THE PATIENT, WHO WAS REPORTEDLY "GREAT" FOLLOWING THE PROCEDURE, FIRST STARTED TO EXPERIENCE PAIN DURING INTERCOURSE WITHIN THREE MONTHS OF THE PROCEDURE (EXACT DATE OF ONSET OF PAIN IS UNKNOWN). A PORTION OF THE MESH HAS SINCE BEEN EXCISED (DATE OF EXCISION UNKNOWN) AND THE PATIENT IS REPORTEDLY DOING "MUCH BETTER" NOW. THE PATIENT NEEDED TO BE HOSPITALIZED FOR AN UNKNOWN DURATION FOLLOWING THE EXCISION PROCEDURE. THE PHYSICIAN WHO PERFORMED THE ORIGINAL PROCEDURE ALSO STATED THAT POST PROCEDURE, THE PATIENT WAS DIAGNOSED WITH INTERSTITIAL CYSTICIS (DATE OF DIAGNOSIS UNKNOWN), WHICH THE PHYSICIAN OPINED COULD BE THE CAUSE OF THE PATIENT'S COMPLICATIONS AS OPPOSED TO THE UPHOLD MESH ITSELF. IT IS UNKNOWN IF THE PATIENT HAD INTERSTITIAL CYSTICIS PRIOR TO THE UPHOLD PROCEDURE. NO FURTHER INFORMATION HAS BEEN FORTHCOMING FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R