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 2018-01-22 for NURO 3533 manufactured by Medtronic Neuromodulation.
[97942600]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[97942601]
The patent reported that the patient experienced bladder infections, blood in their urine and undesirable urgency. The patient also mentioned that preexisting conditions may have been a factor. The patient was reported to be alive with no injury. No further patient complications were reported/ anticipated as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[102633260]
(b)(4). (if information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[102780127]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[102780128]
Additional information received from the healthcare provider (hcp) indicated that prior to implant, they were being treated for recurrent utis. The first positive culture was in 2012, and the last positive culture was (b)(6) 2016. They had 5 negative urine cultures in the last year. The cause of the last bladder infection was a positive e-coli culture in (b)(6) 2016. It was unclear if the bladder infections were related to the patient's underlying urinary dysfunction. It was likely related to prolapse and low vaginal estrogen. It was noted that the bladder infections were not related to the device/therapy. Nothing actions had been recently performed for the urinary tract infection, blood in the urine, and urgency. There were no further complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2018-00230 |
| MDR Report Key | 7211550 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-01-22 |
| Date of Report | 2018-02-01 |
| Date Mfgr Received | 2018-01-26 |
| Date Added to Maude | 2018-01-22 |
| 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 | 2018-01-22 |
| 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 | 2018-01-22 |