BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENESSA RF SYSTEM

    MDR report key: 1393937 · Received May 27, 2009

    Report

    Report Number
    3003647794-2009-00001
    Event Type
    Injury
    Date Received
    May 27, 2009
    Date of Event
    April 22, 2009
    Report Date
    April 22, 2009
    Manufacturer
    NOVASYS MEDICAL
    Product Code
    NVJ
    PMA / PMN Number
    K042132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT APPEARED TO MEET ALL PATIENT SELECTION CRITERIA ACCORDING TO PHYSICIAN AND PROCEDURE WAS PERFORMED ACCORDING TO STANDARD PROTOCOL. NO DEVICE MALFUNCTION WAS NOTED. 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 MANUFACTURE 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, 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 AND THE POTENTIAL NEED FOR ADDITIONAL CHANGES TO THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF EXPERIENCING WORSENED STRESS INCONTINENCE SYMPTOMS 3-4 WEEKS AFTER TREATMENT CHARACTERIZED BY A NEED FOR SIGNIFICANTLY HIGHER NUMBER OF PAD CHANGES PER DAY THAN AT BASELINE. PATIENT UNDERWENT PHYSICAL EXAM AND WAS DIAGNOSED WITH ISD NOT SEEN AT BASELINE. PHYSICIAN INITIALLY DID NO TREATMENT AND OBSERVED THE PATIENT FOR IMPROVEMENT. THE PATIENT CONTINUED TO COMPLAIN OF WORSENED STRESS INCONTINENCE AND UNDERWENT VIDEOURODYNAMICS STUDIES THAT CONFIRMED INTRINSIC SPHINCTER DEFICIENCY AND THE PATIENT UNDERWENT URETHRAL BULKING AGENT INJECTION. AWAITING FURTHER INFORMATION ON FOLLOW-UP FOLLOWING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENESSA RF SYSTEM NVJ NOVASYS MEDICAL PR0918 012508E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RENESSA RF GENERATOR