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 2017-07-13 for NURO 3533 manufactured by Advanced Uro-solutions, L.l.c..
[79917414]
Patient Sequence No: 1, Text Type: N, H10
[79917415]
The patient reported that there were times that they felt like they were ready to burst, would get to the bathroom, stand there for 5-10 minutes, and maybe a little urine would come out. There were other times when the urge would hit, and they would barely make it to the bathroom. These symptoms began prior to the percutaneous tibial neuromodulation (ptnm) treatments. It was indicated that the primary symptom they were being treated for was the process of urinating. The patient noted that they urinated a quart. The issue was not resolved. It was further provided that the patient had leaking prior to the ptnm treatments, but not since. Their healthcare provider (hcp) told them that they had an obstruction, so the hcp clipped it out, and widened the tube running off their bladder. The patient had completed two ptnm sessions at the time of report. There were no further complications reported as a result of this event. Additional information reported that the patient couldn't really tell if the treatment improved their urinary problems. The patient stated that they were a new man for a couple of weeks however they had an infection prior to starting the ptnm sessions and now seemed to be having the same symptoms. It was unknown if the infection had been resolved. The patient reported that their healthcare provider sent their tests off to be biopsied to check the pathology. It was unknown if any environmental/external/patient factors that may have led or contributed to the issue. The patient was reported to be alive with no injury. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[98468240]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[98468241]
Additional information received from the healthcare provider (hcp) indicated that the cause of the urinary obstruction was due to the urethral structure that was long standing and had been there for a long time. The patient was treated on (b)(6) 2017. There were no further complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[99335941]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[99335942]
The patient reported that they were in and out of the hospital so they have not been able to go to their the ptnm sessions. The patient had 3 stints put in because they had a blockage in their heart. The patient noted that they were satisfied with the treatment. The patient noticed the last time they were there that they felt it a little more in their calf than they had the time before. The patient also had a tens machine that they use on their back because their back gives them some trouble. It was unknown if any environmental/external/patient factors that may have led or contributed to the issue. The patient has completed 4 or 5 ptnm sessions. There were no further complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2017-02841 |
| MDR Report Key | 6710199 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-07-13 |
| Date of Report | 2017-08-31 |
| Date Mfgr Received | 2017-08-08 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2017-07-13 |
| 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 MN 301881200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 301881200 |
| 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 | 2017-07-13 |
| 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 MN 301881200 US 301881200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-13 |