MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for VERIFY ENHANCED 353101 manufactured by Medtronic Neuromodulation.
[187368722]
Concomitant medical products: product id: 3889, product type: lead. Other relevant device(s) are: product id: 3889. Date is approximate with month/year validity. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187368723]
Information was received from a consumer regarding an advanced evaluation trial patient with an external neurostimulator (ens) for urge incontinence and urgency frequency. It was reported by an advanced evaluation patient that their device was not working and that they were going to have their leads replaced. On (b)(6) 2002 the patient stated? Ouch.? There were no further complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2020-00090 |
| MDR Report Key | 9903349 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-21 |
| Date Added to Maude | 2020-03-31 |
| 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 | 7000 CENTRAL AVE NE |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55432 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERIFY ENHANCED |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE |
| Product Code | EZW |
| Date Received | 2020-03-31 |
| Model Number | 353101 |
| Catalog Number | 353101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 7000 CENTRAL AVE NE MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |