MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-02-04 for LYRETTE PR0918 manufactured by Novasys Medical.
[4183976]
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.
Patient Sequence No: 1, Text Type: D, B5
[11626939]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3022472-2014-00002 |
| MDR Report Key | 3647905 |
| Report Source | 04 |
| Date Received | 2014-02-04 |
| Date of Report | 2014-01-08 |
| Date of Event | 2014-01-08 |
| Date Mfgr Received | 2014-01-08 |
| Date Added to Maude | 2014-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ADAM GAINES, SR. SPECIALIST |
| Manufacturer Street | 20001 NORTH CREEK PKWY. |
| Manufacturer City | BOTHELL WA 98011 |
| Manufacturer Country | US |
| Manufacturer Postal | 98011 |
| Manufacturer Phone | 4256295606 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1404-2010 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LYRETTE |
| Generic Name | TRANS-URETHRAL RF SYSTEM |
| Product Code | NVJ |
| Date Received | 2014-02-04 |
| Model Number | PR0918 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVASYS MEDICAL |
| Manufacturer Address | NEWARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2014-02-04 |