MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-03-22 for NURO 3533 manufactured by Medtronic Neuromodulation.
[70589583]
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
[70589584]
A patient reported that it was hard to feel the stimulation for the ptnm device because they had fasciitis in their right foot. They did not mention whether they had the fasciitis prior to the beginning of treatments. The patient began receiving the treatments on (b)(6) 2017. No further complications are anticipated.
Patient Sequence No: 1, Text Type: D, B5
[70658224]
The event date of (b)(6) 2017 is no longer applicable to this event. The event date was unclear at the time of the report.
Patient Sequence No: 1, Text Type: N, H10
[74186966]
(b)(4) is no longer applicable to this event. The event is no longer a reportable event. Evaluation code-conclusion is no longer applicable to this event.
Patient Sequence No: 1, Text Type: N, H10
[74186967]
Additional information from the patient mention previously reported information regarding having fasciitis prior to treatments and they still don't feel stimulation during treatments. They also stated that sometimes when they go to the bathroom they feel chills. It happened more so at night, but maybe once or twice during the day. They did not know why it was happening, but did tell their healthcare provider (hcp). They could not recall whether it started before or after the treatments, but stated about five weeks prior to the report. The nurse explained to them that they were not sure if the therapy would work if they could not feel stimulation. The patient stated that their frequency was better at night and then when they were at home, they don't have a problem. During the daytime, they get nervous whenever they had to find a bathroom, the urgency is different all of the time.
Patient Sequence No: 1, Text Type: D, B5
[100829841]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-01076 |
| MDR Report Key | 6425067 |
| Report Source | CONSUMER |
| Date Received | 2017-03-22 |
| Date of Report | 2017-05-02 |
| Date of Event | 2017-03-17 |
| Date Mfgr Received | 2017-04-04 |
| Date Added to Maude | 2017-03-22 |
| 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 | 2017-03-22 |
| 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 | 2017-03-22 |