MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-07 for PERIPHERAL NERVE STIMULATOR NEU_UNKNOWN manufactured by Medtronic Neuromodulation.
[144296253]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[144296254]
Information was received from a patient with a peripheral nerve stimulator. It was reported that the patient had was implanted with a peripheral nerve stimulator in the 1980? S. The patient reported that the wires were damaged in the early 1990? S and the system was removed. No further complications are anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2019-01027 |
| MDR Report Key | 8587212 |
| Report Source | CONSUMER |
| Date Received | 2019-05-07 |
| Date of Report | 2019-06-11 |
| Date Mfgr Received | 2019-05-24 |
| Date Added to Maude | 2019-05-07 |
| 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 | PERIPHERAL NERVE STIMULATOR |
| Generic Name | STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) |
| Product Code | GZF |
| Date Received | 2019-05-07 |
| Model Number | NEU_UNKNOWN |
| Catalog Number | NEU_UNKNOWN |
| 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 | 2019-05-07 |