BEUDAMED
    FDA Adverse Event Other Summary report: N

    RENESSA RF SYSTEM

    MDR report key: 1710464 · Received June 3, 2010

    Report

    Report Number
    3003647794-2010-00086
    Event Type
    Other
    Date Received
    June 3, 2010
    Date of Event
    November 1, 2009
    Report Date
    June 1, 2010
    Manufacturer
    NOVASYS MEDICAL
    Product Code
    NVJ
    PMA / PMN Number
    K042132
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WORSENING INCONTINENCE IS A KNOWN RISK FOLLOWING ANY ANTI-INCONTINENCE PROCEDURE. FOLLOWING RENESSA, SOME PATIENTS HAVE EXPERIENCED A WORSENING OF INCONTINENCE 3-4 WEEKS FOLLOWING THE TREATMENT AT THE TIME THAT THE URETHRAL SUBMUCOSAL TISSUE IS UNDERGOING COLLAGEN REMODELING FOLLOWING URETHRAL SUBMUCOSAL COLLAGEN DENATURATION DURING THE TREATMENT. SYMPTOMS CAN INCLUDE URINARY TRACT INFECTION, OVERFLOW URINARY INCONTINENCE, OVERACTIVE BLADDER, OR INTRINSIC SPHINCTER DEFICIENCY. ALL OF THESE CONDITIONS ARE TREATABLE. THE MANUFACTURER HAS EVALUATED DEVICES ON AN ONGOING BASIS TO DETERMINE IF ANY DEVICE RELATED MALFUNCTION MAY HAVE CONTRIBUTED TO THE OCCURRENCE OF THIS KNOWN ADVERSE EVENT. TO DATE, NO DEVICE MALFUNCTION HAS BEEN FOUND TO CONTRIBUTE TO THE EVENT, BUT INVESTIGATIONS CONTINUE. THE MANUFACTURER HAS CREATED PROCEDURAL AIDS TO EMPHASIZE APPROPRIATE PATIENT SELECTION, HAS SIMPLIFIED THE STEPS OF THE PROCEDURE, MADE CHANGES TO THE INSTRUCTIONS FOR USE, AND HAS MADE MINOR DEVICE CHANGES TO FACILITATE EASE OF USE BY THE PHYSICIAN. THE MANUFACTURER CONTINUES TO EVALUATE THE EFFECTIVENESS OF THESE STEPS TO MINIMIZE THE OCCURRENCE OF THIS SIDE EFFECT. (B)(4).

    Description of Event or Problem · 1

    PATIENT BEGAN TO HAVE WORSENING INCONTINENCE. PATIENT UNDERWENT A URETHRAL SLING PROCEDURE, USING THE SYNTHETIC SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENESSA RF SYSTEM NVJ NOVASYS MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention