BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOGEE

    MDR report key: 1935405 · Received December 15, 2010

    Report

    Report Number
    2183959-2010-00458
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    May 23, 2009
    Report Date
    December 6, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL INFO WAS A MAUDE EVENT REPORT. UNABLE TO CONFIRM IF THE EVENT IS RELATED TO A DEVICE MALFUNCTION, DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS REVISION SURGERY, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT # 2183959-2010-00457 AND # 2183959-2010-00456. IN 2007, THIS PT HAD AN APOGEE DEVICE IMPLANTED FOR RECTOCELE REPAIR. PT HAD PROLONGED POST OPERATIVE RECOVERY, EXPERIENCING PAIN URINARY TRACT INFECTIONS AND DYSPAREUNIA. IN 2010, THE APOGEE DEVICE WAS REMOVED BECAUSE IT WAS THOUGHT TO BE, "CAUSING THE PAIN DUE TO THE WAY IT WAS ANCHORED." PATIENT HAS HAD RELIEF OF THE SEVER PAIN, BUT CONTINUES TO HAVE SOME PAIN. CONTINUES, ALSO TO HAVE DIFFICULTY SITTING FOR LONG PERIODS, BLADDER SPASMS AND URINARY TRACT INFECTIONS. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APOGEE VAGINAL VAULT PROLAPSE REPAIR SYSTEM FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S SPARC SLING SYSTEM| PERIGEE MESH