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 PTS EXPERIENCE TRANSIENT WORSENING OF THEIR INCONTINENCE 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 MFR 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 MFR HAS CREATED PROCEDURAL AIDS TO EMPHASIZE APPROPRIATE PT 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 MFR CONTINUES TO EVALUATE THE EFFECTIVENESS OF THESE STEPS TO MINIMIZE THE OCCURRENCE OF THIS SIDE EFFECT. (B)(4).

Description of Event or Problem

AS PER A DISCUSSION WITH THE PHYSICIAN, A PT UNDERWENT THE PROCEDURE APPROXIMATELY 6 MONTHS PRIOR TO THIS REPORT. SHE SUBSEQUENTLY REPORTED WORSENING INCONTINENCE AND THE PHYSICIAN THEN PERFORMED AN URETHRAL SLING PROCEDURE.