MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-10-05 for NURO 3533 manufactured by Medtronic Neuromodulation.
[88387979]
Patient Sequence No: 1, Text Type: N, H10
[88387980]
A patient reported that their symptoms were "about the same each time". They later stated that the symptoms improved a little bit, but not much. Additional information received from the patient indicated that they could not tell if they were really any better. They advised that some days the therapy was working okay, but not as much lately. The patient stated that they leak a lot, and the leaking started a few months ago, after they had started percutananeous tibial neuromodulation (ptnm) therapy. They mentioned that the healthcare provider (hcp) had done botox on the patient previously, and it was painful. The patient stated that nothing seemed to work on them for anything. It was noted that the patient was trying a new regimen for their colon because they had scar tissue from previous surgeries. There were no further complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2017-04199 |
| MDR Report Key | 6917579 |
| Report Source | CONSUMER |
| Date Received | 2017-10-05 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2017-09-07 |
| Date Added to Maude | 2017-10-05 |
| 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 | 2017-10-05 |
| Model Number | 3533 |
| Catalog Number | 3533 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2017-10-05 |