MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-01-25 for RENESSA RF SYSTEM manufactured by Novasys Medical.
[19186958]
Patient underwent the procedure and reported worsening incontinence approximately two months following the procedure. Following a discussion with her physician, the patient elected to proceed with an urethral sling procedure which was completed within three months following the initial procedure.
Patient Sequence No: 1, Text Type: D, B5
[19516041]
Worsening incontinence is a known risk following any anti-incontinence procedure. Following the renessa procedure, a small number of patients experience transient worsening of their incontinence during the (b)(6) weeks following the treatment which is during the time period when the urethral submucosal collagen is undergoing remodeling. Findings consistent with urinary tract infection, overactive bladder, or intrinsic sphincter deficiency may occur. All of these conditions are treatable. The manufacturer has evaluated devices on an ongoing basis to determine if any device related malfunction may have contributed to the occurrence of this known adverse effect. To date, no device malfunction has been found to contribute to the event, but investigations continue. The manufacturer has created procedural aids to emphasize appropriate patient selection, has simplified the steps of the procedure, made changes to the instructions for use, and has made minor device changes to facilitate ease of use by the physician. The manufacturer continues to evaluate the effectiveness of these steps to minimize the occurrence of this side effect. ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003647794-2011-00087 |
| MDR Report Key | 1971972 |
| Report Source | 04 |
| Date Received | 2011-01-25 |
| Date of Report | 2011-01-01 |
| Date of Event | 2010-11-01 |
| Date Mfgr Received | 2010-12-26 |
| Date Added to Maude | 2012-05-08 |
| 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 | PAT YAZOLINO |
| Manufacturer Street | 39684 EUREKA DR. |
| Manufacturer City | NEWARK CA 94560 |
| Manufacturer Country | US |
| Manufacturer Postal | 94560 |
| Manufacturer Phone | 5102264060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENESSA RF SYSTEM |
| Product Code | NVJ |
| Date Received | 2011-01-25 |
| 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. Required No Informationntervention | 2011-01-25 |