MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-24 for RENESSA RF SYSTEM PR0918 manufactured by Novasys Medical.
[1448810]
Pt began to have worsening incontinence requiring constant changing of pads 4-5 weeks after the procedure. The pt underwent a midurethral sling with improvement.
Patient Sequence No: 1, Text Type: D, B5
[8347135]
No device malfunction occurred. Worsening incontinence is a known risk following any anti-incontinence procedure. Following renessa, some pts have experienced a worsening of incontinence 3-4 weeks following the treatment at the time that the urethral submucosal tissue is undergoing collagen remodeling following urethral submucosal collagen denaturation during the treatment. Symptoms can include urinary tract infection, overflow urinary incontinence, overactive bladder, or intrinsic sphincter deficiency. 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 event. 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 pt 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. The manufacturer is submitting this report retrospectively following a review of complaints after establishing that this event should be mdr reportable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003647794-2009-00066 |
| MDR Report Key | 1569932 |
| Report Source | 05 |
| Date Received | 2009-12-24 |
| Date of Report | 2009-12-01 |
| Date of Event | 2008-12-01 |
| Date Mfgr Received | 2009-02-05 |
| Date Added to Maude | 2010-01-07 |
| 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 | 2009-12-24 |
| Model Number | PR0918 |
| Catalog 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. Required No Informationntervention | 2009-12-24 |