MAUDE Adverse Event Report: VERATHON MEDICAL LYRETTE; TRANS-URETHRAL RF SYSTEM

Model Number PR918

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Incontinence (1928)

Event Date 03/06/2014

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: LYRETTE
• Type of Device: TRANS-URETHRAL RF SYSTEM
• Manufacturer (Section D): VERATHON MEDICAL; newark NJ
• Manufacturer Contact: carmen wassell ; 20001 n. creek pkwy; bothell, WA 98011 ; 4256295674
• MDR Report Key: 3824473
• MDR Text Key: 4402857
• Report Number: 3022472-2014-00010
• Device Sequence Number: 1
• Product Code: NVJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PR918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1404-2010
• Patient Sequence Number: 1
• Treatment: LOCAL ANESTHESIA; LYRETTE GENERATOR: MODEL #GN602
• Patient Outcome(s): Disability
• Patient Age: 68 YR