RENESSA RF SYSTEM

Additional Manufacturer Narrative

NO DEVICE MALFUNCTION OCCURRED. WORSENING INCONTINENCE IS A KNOWN RISK FOLLOWING ANY ANTI-INCONTINENCE PROCEDURE. FOLLOWING RENESSA, SOME PTS 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 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. THE MFR IS SUBMITTING THIS REPORT RETROSPECTIVELY FOLLOWING A REVIEW OF COMPLAINTS AFTER ESTABLISHING THAT THIS EVENT SHOULD BE MDR REPORTABLE.

Description of Event or Problem

PT BEGAN TO HAVE WORSENING INCONTINENCE REQUIRING CONSTANT CHANGING OF PADS 4-5 WEEKS AFTER THE PROCEDURE. PT RECEIVED BULKING AGENT WITH IMPROVEMENT.