BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2221697 · Received August 24, 2011

    Report

    Report Number
    3005099803-2011-02775
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2009, THE PATIENT UNDERWENT A BLADDER SUSPENSION (DEVICE USED UNKNOWN). SHE DEVELOPED AN INFECTION AFTER THE PROCEDURE AND WAS GIVEN IV ANTIBIOTICS (EXACT TYPE UNKNOWN), BUT HAD NO INCONTINENCE. LATER IN THE MONTH, THE PATIENT WENT TO SEE THE PHYSICIAN COMPLAINING OF PAIN AND DISCOMFORT DURING INTERCOURSE. THE PHYSICIAN EXAMINED THE PATIENT AND DISCOVERED THAT SHE HAD MESH EXPOSURE AND A SHORTENED VAGINAL VAULT. ON (B)(6) 2009, THE PHYSICIAN REMOVED THE PINNACLE MESH FROM THE PATIENT AND PERFORMED A VAGINOPLASTY IN AN ATTEMPT TO REPAIR THE SHORTENING OF THE VAGINAL VAULT. THE VAGINOPLASTY WAS REPORTEDLY UNSUCCESSFUL, AND IT WAS REPORTED ON (B)(6) 2011, THAT THE PATIENT HAS CONTINUED TO EXPERIENCE SHORTENING OF HER VAGINAL VAULT, TO ITS CURRENT LENGTH OF THREE INCHES. SHE IS UNABLE TO HAVE INTERCOURSE AND HAS CONTINUING PROBLEMS WITH URINATION. THE PATIENT WILL UNDERGO A SKIN GRAFT PROCEDURE TO ATTEMPT TO FIX THE PROBLEM. ALL OTHER INFORMATION, INCLUDING FURTHER INFORMATION REGARDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK558

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention