RENESSA RF SYSTEM

Description of Event or Problem

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

Additional Manufacturer Narrative

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).