MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-10-19 for NURO 3533 manufactured by Medtronic Neuromodulation.
[89755075]
Patient Sequence No: 1, Text Type: N, H10
[89755076]
The consumer reported that the patient has an urinary tract infection (uti), and was currently on antibiotics. It was also indicated that the patient may be retaining some urine. The consumer indicated that they would schedule a bladder scan. The patient had currently stopped percutaneous tibial neuromodulation (ptnm) treatments, but the consumer wanted them to get back on them as soon as the uti cleared and the bladder scan test came back. There were no further complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2017-04474 |
| MDR Report Key | 6962611 |
| Report Source | CONSUMER |
| Date Received | 2017-10-19 |
| Date of Report | 2017-10-19 |
| Date Mfgr Received | 2017-09-25 |
| Date Added to Maude | 2017-10-19 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NURO |
| Generic Name | STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION |
| Product Code | NAM |
| Date Received | 2017-10-19 |
| Model Number | 3533 |
| Catalog Number | 3533 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-19 |