MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-30 for NURO 3533A manufactured by Medtronic Neuromodulation.
[174517423]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[174517424]
Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient using an external neurostimulator (ens). It was reported that the hcp asked the rep if it was typical for a patient? S toe to become cyanotic while receiving percutaneous tibial neuromodulation (ptnm). The hcp stated a patient? S toe became cyanotic only when receiving the therapy. They noted the patient did not complain and the hcp continued to deliver the therapy, noting the patient? S overactive bladder (oab) was improving. No device issues or further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2019-02625 |
| MDR Report Key | 9530592 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-30 |
| Date of Report | 2020-03-05 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2019-12-30 |
| 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 SUITE D |
| Manufacturer City | MINNEAPOLIS,MN GA 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 | 2019-12-30 |
| Model Number | 3533A |
| Catalog Number | 3533A |
| 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 SUITE D MINNEAPOLIS,MN GA 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-30 |