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 2017-06-03 for NURO 3533 manufactured by Medtronic Neuromodulation.
[76589534]
Patient Sequence No: 1, Text Type: N, H10
[76589535]
A patient reported that they didn't think the therapy was doing enough because they were still having accidents all over the place. The healthcare provider (hcp) stated that maybe the 12 weekly sessions helped, but the monthly ones did not. The patient was not sure if event the 12 weekly sessions worked because they were on medications. It was noted that the hcp may have cleared up the infection the patient had in (b)(6), as they were no longer taking antibiotics. They said the therapy maybe helped a little, but it was not to their satisfaction. The patient said they think that they may be sensitive to some food that may have been irritating their bladder, and they have irritable bladder. 14 ptnm therapy sessions had been completed. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[100157692]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[100162200]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[100162201]
Additional information received from the healthcare provider (hcp) indicated the e. Coli was treated in (b)(6) 2017. In (b)(6) 2017, 10,000 colony formed units were cultured. It was noted that their last ptnm session was (b)(6) 2017. The hcp further provide that the patient had a pelvic muscle exercise biofeedback office visit in (b)(6) 2017. There were no further complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2017-02149 |
| MDR Report Key | 6610176 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-06-03 |
| Date of Report | 2017-09-08 |
| Date Mfgr Received | 2017-08-16 |
| Date Added to Maude | 2017-06-03 |
| 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 | 2017-06-03 |
| 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. Required No Informationntervention | 2017-06-03 |