MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2017-06-03 for NURO 3533 manufactured by Medtronic Neuromodulation.
[76589469]
Patient Sequence No: 1, Text Type: N, H10
[76589470]
A patient reported their frequency had been worse. The healthcare provider (hcp) ran a test for possible urinary tract infection. The patient had not received the results yet. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[76633785]
Patient Sequence No: 1, Text Type: N, H10
[80519157]
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury. Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803. Patient code (b)(4) and evalatuion code-conclusion no longer apply to this event.
Patient Sequence No: 1, Text Type: N, H10
[80519158]
Additional information received from the healthcare provider (hcp) indicated that the urine outcome was negative. There was no uti.
Patient Sequence No: 1, Text Type: D, B5
[100962351]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-02148 |
| MDR Report Key | 6610171 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-06-03 |
| Date of Report | 2017-07-19 |
| Date Mfgr Received | 2017-07-14 |
| Date Added to Maude | 2017-06-03 |
| 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 | 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 | 2017-06-03 |
| Model Number | 3533 |
| Catalog Number | 3533 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2017-06-03 |