MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-05-06 for LYRETTE PR918 manufactured by Verathon Medical.
[4402857]
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.
Patient Sequence No: 1, Text Type: D, B5
[11741450]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3022472-2014-00010 |
| MDR Report Key | 3824473 |
| Report Source | 04 |
| Date Received | 2014-05-06 |
| Date of Report | 2014-03-14 |
| Date of Event | 2014-03-06 |
| Date Mfgr Received | 2014-03-14 |
| Date Added to Maude | 2014-05-22 |
| 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 | CARMEN WASSELL |
| Manufacturer Street | 20001 N. CREEK PKWY |
| Manufacturer City | BOTHELL WA 98011 |
| Manufacturer Country | US |
| Manufacturer Postal | 98011 |
| Manufacturer Phone | 4256295674 |
| 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 | 2014-05-06 |
| Model Number | PR918 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERATHON MEDICAL |
| Manufacturer Address | NEWARK NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2014-05-06 |