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 2017-04-04 for NURO 3533 manufactured by Medtronic Neuromodulation.
[71618727]
Patient Sequence No: 1, Text Type: N, H10
[71618728]
A healthcare provider reported on behalf of a patient that they stopped therapy due to a rash reaction they got after the treatment. Follow up on (b)(6) 2017, from the patient's family member, reported that the patient did not have an allergic reaction to the therapy, but a urinary tract infection. As a result, the patient's symptoms had worsened, going as frequent as 19-20 times a day. They stated that it has been "horrible" and the patient can't go anywhere. It was noted that the healthcare provider was aware of the issue. No further complications are anticipated.
Patient Sequence No: 1, Text Type: D, B5
[72809019]
Patient code (b)(4) is no longer applicable to the event.
Patient Sequence No: 1, Text Type: N, H10
[72809020]
Additional information from the healthcare provider stated that the rash the patient has was a bacterial infection secondary to dampness from incontinence. The patient did not have a urinary tract infection, but had incontinence increased and the rash was secondary to it. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[100946105]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-01265 |
| MDR Report Key | 6456561 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-04-04 |
| Date of Report | 2017-04-14 |
| Date Mfgr Received | 2017-04-04 |
| Date Added to Maude | 2017-04-04 |
| 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 | 2017-04-04 |
| 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 | 2017-04-04 |