MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-01 for NURO 3533 manufactured by Medtronic Neuromodulation.
[90790437]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[90790438]
The patient reported that the nurse was having a lot of difficulty setting up a device and the device was not working at one point, but the manufacturer representative (rep) came in and resolved it. It was further provided that the patient's perception of therapy was a 2 on (b)(6) 2017, but they stated that their symptom relief was not worse than before they began treatment. It was just their symptoms had been getting better, and then they had a couple of issues where they could not get to the bathroom. They also reported that 20-30 minutes after voiding, they felt a strong urge to void, but couldn't. They were surprised by this. It was noted that the patient had neuropathy, and on (b)(6) 2017 after treatment, they had tingling going up both of their legs for the rest of the day. The patient had completed 4 sessions. There were no further complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[101044466]
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. (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[101044467]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2017-04646 |
| MDR Report Key | 6993854 |
| Report Source | CONSUMER |
| Date Received | 2017-11-01 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-10-10 |
| Date Mfgr Received | 2017-12-06 |
| Date Added to Maude | 2017-11-01 |
| 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 | 2017-11-01 |
| 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 | 2017-11-01 |