MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-04-24 for NURO 3533 manufactured by Medtronic Neuromodulation.
[73493848]
Patient Sequence No: 1, Text Type: N, H10
[73493849]
The patient reported that they tend to get bladder infections and has one small infection since the beginning of their ptnm treatments but has been resolved. It was unknown if any environmental/external/patient factors led or contributed to the issue. The patient stated that they had colon cancer years ago and was advised that they would have bladder issues down the road. The patient had severe bladder issues and would catheterize about 15 times a day and retains urine. The number of times they catheterizes per day has not changed since beginning the ptnm treatments. The patient began their ptnm treatments on (b)(6) 2017. The patient was reported to be alive with no injury. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[76633446]
Patient Sequence No: 1, Text Type: N, H10
[76633447]
Additional information from the patient reported their symptoms are much better and they had a good flow, but still catheterizing after. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[100184532]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-01548 |
| MDR Report Key | 6515878 |
| Report Source | CONSUMER |
| Date Received | 2017-04-24 |
| Date of Report | 2017-05-26 |
| Date of Event | 2017-02-10 |
| Date Mfgr Received | 2017-05-01 |
| Date Added to Maude | 2017-04-24 |
| 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 | 2017-04-24 |
| 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 | 2017-04-24 |