LYRETTE

Description of Event or Problem

ON (B)(4) 2013, THE PT UNDERWENT A LYRETTE PROCEDURE UNDER LOCAL ANESTHETIC FOR STRESS INCONTINENCE. TWENTY FOUR (24) HOURS LATER, THE PT EXPERIENCED HEMATURIA, AND 1 WEEK LATER THE INCONTINENCE BEGAN TO WORSEN TO WHERE SHE NEEDED PADS, WHICH HADN'T BEEN NECESSARY BEFORE. OVER THE FOLLOWING WEEKS THE INCONTINENCE CONTINUED TO WORSEN WITH SEVERAL LEAKS A DAY. FURTHER MEDICAL INVESTIGATION WAS CONDUCTED BY VERATHON'S CONSULTING PHYSICIAN IN CONJUNCTION WITH THE PT'S UROLOGIST, AND THEY BOTH REACHED THE FOLLOWING CONCLUSION: THE PT WAS NOT AN IDEAL CANDIDATE FOR LYRETTE BECAUSE OF HER DEGREE OF HYPERMOBILITY (POP SCORE APPROACHING 2) AND A POSSIBLY TOO SHORT URETHRA. THE LYRETTE PROCEDURE MAY HAVE BEEN DONE INCORRECTLY (TOO MUCH TRACTION ON THE CATHETER RESULTING IN TREATMENT TOO CLOSE TO THE SPHINCTER). THE LYRETTE PROCEDURE DID MAKE THE PT'S INCONTINENCE WORSE (PROBABLY BECAUSE OF 1 AND 2). SHE NOW HAS AN ELEMENT OF ISD (INTRINSIC SPHINCTER DEFICIENCY) THAT SHE DID NOT HAVE PRIOR TO THE LYRETTE PROCEDURE. THE PT SCHEDULED A SLING PROCEDURE FOR (B)(6) 2013.

Additional Manufacturer Narrative

CATHETER PR0918: THE CATHETER WAS DISCARDED, AND THE SERIAL NUMBER WAS NOT AVAILABLE FROM THE COMPLAINANT. THE COMPLETE STREET ADDRESS NOT PROVIDED BY COMPLAINANT. RESULT: A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THE GENERATOR PASSED TESTING/INSPECTION. FDA RECALL Z-1404-2010, INSTRUCTIONS FOR USE (IFU) REVISION: BECAUSE OF COMPLAINTS RECEIVED BY NOVASYS OF WORSENED STRESS INCONTINENCE SYMPTOMS 3-4 WEEKS AFTER TREATMENT, THE INSTRUCTIONS FOR USE WERE REVISED TO EMPHASIZE POTENTIAL SIDE EFFECTS. A FIELD ACTION NOTIFICATION LETTER WAS SENT TO ALL CURRENT CUSTOMERS (PHYSICIANS) ALONG WITH THE REVISED INSTRUCTIONS FOR USE AND PT INFORMATION BROCHURES. THE COMPANY ALSO UPDATED PHYSICIAN INFORMATION BROCHURES AND PT/PHYSICIAN DVDS TO INCLUDE THE INFORMATION. THIS WAS SHIPPED TO PHYSICIANS IN (B)(4) OF 2009. THE LETTER INCLUDED NOTICE THAT THE INSTRUCTIONS FOR USE HAD REINFORCED LANGUAGE THAT ONE OF THE POTENTIAL SIDE EFFECTS OF THE RENESSA SYSTEM (LYRETTE) IS WORSENING INCONTINENCE FOLLOWING TREATMENT. IT ALSO STATED THAT WOMEN WITH A URETHRAL LENGTH SHORTER THAN 2.5 CM SHOULD NOT BE TREATED WITH RENESSA.