BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYRETTE

    MDR report key: 3824473 · Received May 6, 2014

    Report

    Report Number
    3022472-2014-00010
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 14, 2014
    Manufacturer
    VERATHON MEDICAL
    Product Code
    NVJ
    PMA / PMN Number
    K042132
    Removal / Correction Number
    Z-1404-2010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED BUT EXACT WEIGHT WAS NOT PROVIDED. NOT APPLICABLE, NO FOLLOW UP TESTING PERFORMED. SERIAL NUMBER NOT AVAILABLE, PROBES ARE DISCARDED AFTER USE. NOT AVAILABLE, REQUIRES SERIAL NUMBER. 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 PATIENT INFORMATION BROCHURES. THE COMPANY ALSO UPDATED PHYSICIAN INFORMATION BROCHURES AND PATIENT/PHYSICIAN DVDS TO INCLUDE THE INFORMATION. THIS WAS SHIPPED TO PHYSICIANS ON 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 · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT A LYRETTE PROCEDURE FOR STRESS URINARY INCONTINENCE. IMMEDIATELY FOLLOWING THE PROCEDURE, THE PATIENT REPORTED THAT HER INCONTINENCE HAD WORSENED. THE PATIENT'S PHYSICIAN STATED THAT A "INCONTINENCE" PESSARY WAS INSTALLED AND THE PATIENT HAS SEEN A REDUCTION IN SYMPTOMS. ON (B)(6) 2014, VERATHON'S CONSULTING PHYSICIAN CONTACTED THE PATIENT'S PHYSICIAN AND WAS TOLD THAT THE PATIENT HAS A FOLLOW-UP VISIT IN 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270985 LYRETTE TRANS-URETHRAL RF SYSTEM NVJ VERATHON MEDICAL PR918

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Disability LOCAL ANESTHESIA| LYRETTE GENERATOR: MODEL #GN602