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 2017-04-19 for NURO 3533 manufactured by Medtronic Neuromodulation.
[73221387]
Patient Sequence No: 1, Text Type: N, H10
[73221388]
A patient reported that the first four sessions of their ptnm therapy sessions were good and then the 5th one was terrible. They had to discontinue the treatments. During the fifth treatment, they had a lot of pain during and after the "injection". The bottom on their foot hurt since then for at least two weeks. They had severe pain and spasms up their legs and still has spasms once or twice a day on their upper leg. They get up in the morning and have a lot of pain in their leg, and then again before they go to bed at night. They have pain. Their last ptnm treatment was on (b)(6) 2017 and that following monday they went into the er for bronchitis/asthma attack. They could not breathe and they were coughing all the time. They were placed on oxygen. The following friday, they went into the hospital and was there until about a week ago. An ultrasound showed some blood clot areas, but nothing to pinpoint the problem. They stated that their bladder was terrible again and they had no control. The patient stated they had been on many antibiotics and they were not sure if that helped, but they were feeling better. They were doing physical therapy, still wearing 5 pads per night and when they wake up in the morning the pad is soaked. The patient would follow up with their hcp. No further complications are anticipated.
Patient Sequence No: 1, Text Type: D, B5
[98687207]
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
| Report Number | 3007566237-2017-01488 |
| MDR Report Key | 6504575 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-04-19 |
| Date of Report | 2017-04-19 |
| Date of Event | 2017-03-15 |
| Date Mfgr Received | 2017-04-06 |
| Date Added to Maude | 2017-04-19 |
| 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 | 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 | 2017-04-19 |
| 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 | 2017-04-19 |