MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-03-01 for NURO 3533 manufactured by Advanced Uro-solutions, L.l.c..
[68748345]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[68748346]
A patient reported that since starting the therapy their left leg had been bothering them with muscle spasms. It was the same leg they were getting treatment on. They noted they had neuropathy since 1999 and believed that the treatment had been aggravating it. It was hard for them to get out of bed. The patient also mentioned they had a revision on their knee. They spoke to their healthcare provider about the issues and the hcp stated that it had nothing to do with the treatments, so they would try to administer the treatment to patients other leg. The patient was concerned about that option because they had ruptured that achilles heel and had screws in place and didn't want any further problems. After starting the treatments, the patient also reported they had to wait 5-10 minutes before they can void. Sometimes when they push, they feel like their straining which is not good, the urine should just come out. After the first treatment, they could not void. They had no urge to go, and they did not feel their bladder full either. That seemed abnormal to the patient because they consumed a lot of caffeine and water to be able to go to the bathroom. They also felt as though they were off balance as though they may fall. They advised that they almost fell on top of their spouse a couple of week prior to the report. Their hcp stated that was odd and to monitor it. The patient now walks with a cane, since starting treatments, which the hcp was aware of. The patient also noted that they had problems with their lowerback and had a morphine pump that was prior to the treatments. The patient had completed 4 sessions total.
Patient Sequence No: 1, Text Type: D, B5
[70579852]
(b)(4) is no longer applicable to this event.
Patient Sequence No: 1, Text Type: N, H10
[110478326]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012165443-2017-00009 |
| MDR Report Key | 6369169 |
| Report Source | CONSUMER |
| Date Received | 2017-03-01 |
| Date of Report | 2017-03-22 |
| Date of Event | 2017-02-07 |
| Date Mfgr Received | 2017-03-22 |
| Date Added to Maude | 2017-03-01 |
| 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 CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | ADVANCED URO-SOLUTIONS, L.L.C. |
| Manufacturer Street | 7842 HICKORY FLAT HIGHWAY SUITE D |
| Manufacturer City | WOODSTOCK GA 30188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30188 |
| 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 | 2017-03-01 |
| 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 | ADVANCED URO-SOLUTIONS, L.L.C. |
| Manufacturer Address | 7842 HICKORY FLAT HIGHWAY SUITE D WOODSTOCK GA 30188 US 30188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-01 |