BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYRETTE

    MDR report key: 3647905 · Received February 4, 2014

    Report

    Report Number
    3022472-2014-00002
    Event Type
    Injury
    Date Received
    February 4, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 8, 2014
    Manufacturer
    NOVASYS MEDICAL
    Product Code
    NVJ
    PMA / PMN Number
    K042132
    Removal / Correction Number
    Z-1404-2010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72628 LYRETTE TRANS-URETHRAL RF SYSTEM NVJ NOVASYS MEDICAL PR0918

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Disability LOCAL ANESTHESIA