RENESSA RF SYSTEM

Additional Manufacturer Narrative

WORSENING INCONTINENCE IS A KNOWN RISK FOLLOWING ANY ANTI-INCONTINENCE PROCEDURE. FOLLOWING THE RENESSA PROCEDURE, A SMALL NUMBER OF PATIENTS EXPERIENCE TRANSIENT WORSENING OF THEIR INCONTINENCE DURING THE (B)(6) WEEKS FOLLOWING THE TREATMENT WHICH IS DURING THE TIME PERIOD WHEN THE URETHRAL SUBMUCOSAL COLLAGEN IS UNDERGOING REMODELING. FINDINGS CONSISTENT WITH URINARY TRACT INFECTION, OVERACTIVE BLADDER, OR INTRINSIC SPHINCTER DEFICIENCY MAY OCCUR. 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 EFFECT. 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

PATIENT UNDERWENT THE PROCEDURE AND REPORTED WORSENING INCONTINENCE APPROXIMATELY TWO MONTHS FOLLOWING THE PROCEDURE. FOLLOWING A DISCUSSION WITH HER PHYSICIAN, THE PATIENT ELECTED TO PROCEED WITH AN URETHRAL SLING PROCEDURE WHICH WAS COMPLETED WITHIN THREE MONTHS FOLLOWING THE INITIAL PROCEDURE.