MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-18 for NURO 3533 manufactured by Medtronic Neuromodulation.
[111407066]
The date this event occurred was unclear. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[111407067]
Information was received from a consumer (con) via a manufacturer representative (rep) regarding a patient who was using an external neurostimulator (ens). It was reported that the patient was on their fourth session and it was worth it. However, their doctor would have trouble getting the needle into the patient? S ankle due to swelling. The sessions would hurt due to lead placement. Additional information received from the patient indicated that the process of finding the nerve was very painful. After they finally found it, the patient's skin was itchy. It was provided that the following day, the patient got a urinary tract infection. There were no further complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2018-01813 |
| MDR Report Key | 7611818 |
| Report Source | CONSUMER |
| Date Received | 2018-06-18 |
| Date of Report | 2018-06-18 |
| Date Mfgr Received | 2018-05-31 |
| Date Added to Maude | 2018-06-18 |
| 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 | 2018-06-18 |
| 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. Other | 2018-06-18 |