LYRETTE

Additional Manufacturer Narrative

ADDITIONAL DEVICE COMPONENT: LYRETTE GENERATOR MODEL NUMBER GN0602. THIS DEVICE WAS MANUFACTURED BY NOVASYS. VERATHON, INC. PURCHASED NOVASYS ON (B)(4) 2013, BUT HAS NOT YET DISTRIBUTED ANY VERATHON MANUFACTURED DEVICES. 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 CUSTOMER (PHYSICIANS) ALONG WITH THE REVISED INSTRUCTIONS FOR USE AND PATIENT INFORMATION BROCHURES. THE COMPANY ALSO UPDATED PHYSICIAN INFORMATION BROCHURES AND PATIENT/PHYSICIAN DVDS TO INCLUDE THE INFORMATION. THIS WAS SHIPPED TO PHYSICIANS IN AUGUST/SEPTEMBER 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 2.5CM SHOULD NOT BE TREATED WITH RENESSA.

Description of Event or Problem

ON (B)(6) 2013, THE PATIENT UNDERWENT A LYRETTE PROCEDURE FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2014, THE PATIENT REPORTED THAT HER INCONTINENCE HAD WORSENED. FURTHER MEDICAL INVESTIGATION WAS CONDUCTED BY VERATHON'S CONSULTING PHYSICIAN IN CONJUNCTION WITH THE PATIENT'S PHYSICIAN. IT WAS CONCLUDED THAT IT IS TOO EARLY POST-OPERATIVELY TO KNOW THE OUTCOME OF THE PROCEDURE, AND FURTHER, THE PATIENT HAS A COMPLICATING DIAGNOSIS OF INTERSTITIAL CYSTITIS (IC), WHICH COULD EXACERBATE INCONTINENCE.