MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-03-30 for NURO 3533 manufactured by Medtronic Neuromodulation.
[71277232]
Patient Sequence No: 1, Text Type: N, H10
[71277233]
The patient reported via manufacture representative that they had pain down by their pelvic bone. It was noted that it hurt like a really bad cramp or infection but worse. The patient had to go to the hospital and was told that they had a urinary tract infection but was later told by their healthcare provider that they did not have one which was prior to the patient starting their ptnm treatments? A week or 3 weeks? Prior to the day of the report. The patient also reported that they were not emptying their bladder completely. It was unknown if any environmental/external/patient factors led or contributed to the issue. The patient also stated that they had poor blood circulation and had to have another surgery for that as well as their lower back. The patient began their treatments on (b)(6) 2017. The patient? S medical history also included high blood pressure, scoliosis, sciatica, back? Hear? And kidney trouble. The patient was reported to be alive with no injury. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[75232479]
Patient Sequence No: 1, Text Type: N, H10
[75232480]
Additional information reported that both of the patient? S legs are swollen and the treatment is being administered in the leg that is less swollen. The patient was told that this may prevent the treatment from working properly. The patient also reported that their kidneys were bad as well. They noted that sometimes it hurts and it takes a while to pee. The patient had also completed botox before but had to cancel the second treatment because they became really sick. The patient was taking oxybutynin and advised that it isn? T working. The patient could not sleep at night, did not have an appetite and these were side effects of the medication; they would also get really nervous. It was noted that the patient was concerned that their leakage (incontinence) seems to be getting worse. The patient was scheduled for a heart stress test on (b)(6). They also noted that they needed to have their stents cut to get the circulation going before they could have the operation on their back. The patient advised that they only had 2 ptnm sessions and it seems as though urine is coming out more than before. The pad was? Blowing up like a balloon.? The patient also had pain in the bottom of their stomach and their provider could not figure out what it is. The patient advised that this has been going on for a year. The patient also advised that they had to keep her anxiety and depression under control before they operate and she is trying hard, especially when nothing is going right. The patient had pain medication but they felt a lot more pain. The patient was not feeling good on the day of the report and was stressed. The patient was told that they would be done on (b)(6) 2017 but would be getting operated on soon and would not be able to go. It was noted that the patient? S urine was going like a water fall and it was more than before. The patient also stated that their healthcare provider did a scan and there was a little bit left. The healthcare asked the patient if they were drinking a lot and the patient stated that it was no more than normal. Prior to starting the ptnm treatments, the patient received a scan and they had only emptied half of their bladder. The patient take medication at night for anxiety and their healthcare provider told them not to take this medication too close to the other medication they were taking because it can cause them to not wake up. The medication confused them, messes with their memory, and made them not eat. It was also noted that the patient had lost weight.
Patient Sequence No: 1, Text Type: D, B5
[76632832]
Patient Sequence No: 1, Text Type: N, H10
[76632833]
Additional information from the patient reported that they did not think the ptnm therapy was doing any good and their back was hurting them real bad, as previously reported. The urine was just pouring out and the last time they went to the healthcare providers (hcp) office, they told the lady that the pee went all over their leg and it looked like something dark was in the middle of it almost like snot. The nurse had the patient pee in a cup and they told the patient that nothing was wrong. The patient stated they went to the kidney hcp and explained that they were hurting and they did a urine test and said they had an infection. They had been sick and had to go to the hospital because of their back and they could hardly walk. The patient had completed 5 ptnm sessions. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[78147394]
Patient Sequence No: 1, Text Type: N, H10
[78147395]
Additional information reported that the patient couldn? T tell a whole lot of difference in their urinary symptoms. After the patient would have a session they seemed to go more. The patient noted that they were tired of wearing pads. The patient stated that sometimes when they would go to the bathroom the pad? Was blowing up like a bubble.? The patient wondered if their? Bladder had dropped.? It was unknown if any environmental/external/patient factors that may have led or contributed to the issue. The patient had completed 9 ptnm sessions at the time of the report. The patient was reported to be alive with no injury. No further complications reported and/or anticipated.
Patient Sequence No: 1, Text Type: D, B5
[80930589]
Patient Sequence No: 1, Text Type: N, H10
[80930590]
Additional information received from the patient indicated the therapy wasn't doing them any good and was working the opposite. They stated that urine was coming out more, so the healthcare provider (hcp) told them to restart taking oxybutynin. Their urinary symptoms were getting to be a big problem and were frustrating. The patient mentioned that as soon as they sat down, they had to go to the bathroom again; their pad was full. They didn't see the point in continuing the therapy. It was further stated that it was aggravating that they had to take a bunch of pads with them and change so often. They had botox done and some other procedures previously. They were very uncomfortable and wanted to get better. It was noted that they were going to have lower back surgery, and once that healed, they were going to have surgery on their spine. The patient also indicated that their kidneys were doing ok; they were on the second level, they usually stayed on the third. The patient had a lot of protein in their kidneys. The patient had a lot going on and had a lot of issues with their health and private life. The issue was not resolved. They had completed about 8 sessions. This conflicts with the previous report of completing 9 sessions. There were no further complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[98562362]
(b)(4) was removed as it does not apply to this event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[99343400]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-01205 |
| MDR Report Key | 6446364 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-03-30 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-03-24 |
| Date Mfgr Received | 2017-07-05 |
| Date Added to Maude | 2017-03-30 |
| 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 | 2017-03-30 |
| 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 | 2017-03-30 |