MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-04-12 for NURO 3533 manufactured by Medtronic Neuromodulation.
[72589073]
Patient Sequence No: 1, Text Type: N, H10
[72589074]
A consumer via a manufacturer representative reported that she fell many times and her mind was very foggy during a period that lasted for almost two weeks, and advised that she could not think well. The falling ceased about four (4) days ago and her mind was functioning again, but she was still feeling weak. The consumer went to her doctor. The issue was noted as not resolved at the time of the report. A patient reported they had been falling and that they fell and broke their arm. No further complications are anticipated.
Patient Sequence No: 1, Text Type: D, B5
[74265144]
Patient Sequence No: 1, Text Type: N, H10
[74266834]
Patient Sequence No: 1, Text Type: N, H10
[74266835]
Additional information reported that on 2017-01-16 the patient? S healthcare provider received notice that the patient was having an adverse reaction to toviaz. No reports of any other falls until (b)(6) 2017. The patient was taken to the emergency room on either (b)(6) 2017 due to severe tremors, no cognitive responses and inability to walk/stand. The patient was told to discontinue their medications by their healthcare provider. The cause of the patient? S fall and breaking their arm was unknown.
Patient Sequence No: 1, Text Type: D, B5
[98694072]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-01386 |
| MDR Report Key | 6486779 |
| Report Source | CONSUMER |
| Date Received | 2017-04-12 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-01-21 |
| Date Mfgr Received | 2017-04-17 |
| Date Added to Maude | 2017-04-12 |
| 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 | 2017-04-12 |
| 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 | 2017-04-12 |