MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-02 for NURO 3533 manufactured by Advanced Uro-solutions, L.l.c..
[74252258]
Patient Sequence No: 1, Text Type: N, H10
[74252259]
A patient reported they missed their 8th ptnm session on (b)(6) 2017 because they were in the hospital. They had pains in the chest and their blood pressure was low and they were having chest spasms. They went to see a cardiologist the day prior to the report for heart spasms and they were unsure of what was causing it. They were not feeling any better on the day of the report, and they could not walk. Their left leg was so swollen. The healthcare provider (hcp) was aware of the issue, but they were not sure what they were going to do. The patient stated that the hcp's said they were dehydrated because they were not drinking enough. The patient noted they had gout and they were on medication for it. They were also taking medication for urinary symptoms. The patient began their ptnm therapy sessions on (b)(6) 2017. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[75014584]
Product problem is no longer applicable to this event. 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
[77372894]
It was initially reported that the patient had 1 ptnm session. This information was incorrect.
Patient Sequence No: 1, Text Type: N, H10
[77372895]
The patient had completed 11 percutaneous tibial neuromodulation sessions.
Patient Sequence No: 1, Text Type: D, B5
[78495796]
After review, patient codes (b)(4) no longer apply to this event. 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 or that the device in this report has malfunctioned. Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803. 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
[80159874]
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
[80159875]
Additional information received from the patient indicated that they had been in and out of the hospital. They were having problems with their heart, and were on two different types of medications. Their perception of therapy was a 5 due to having ten hernia operations on their right side as well as a testicle removed. The patient further provided that they had "a problem. " the patient had completed 1 percutaneous tibial neuromodulation sessions. There were no further complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[110478329]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012165443-2017-00017 |
| MDR Report Key | 6539186 |
| Report Source | CONSUMER |
| Date Received | 2017-05-02 |
| Date of Report | 2017-06-27 |
| Date Mfgr Received | 2017-06-12 |
| Date Added to Maude | 2017-05-02 |
| 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 | 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 | 2017-05-02 |
| 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. Hospitalization | 2017-05-02 |