RENESSA RF SYSTEM
Received Mar 1, 2010 · Event occurred Dec 1, 2009
Report 3003647794-2010-00085 · MDR key 1620166
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Incontinence
Narrative
Additional Manufacturer Narrative
NO DEVICE MALFUNCTION OCCURRED. 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. (B)(4).
Description of Event or Problem
PATIENT BEGAN TO HAVE WORSENING INCONTINENCE REQUIRING CONSTANT CHANGING OF PADS, 4-5 WEEKS AFTER THE PROCEDURE.