MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-29 for NUVECTRA CORPORATION 2408 manufactured by Nuvectra Corporation.
Report Number | 3010309840-2019-00241 |
MDR Report Key | 9392008 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2019-11-29 |
Date of Report | 2019-11-29 |
Date of Event | 2019-11-01 |
Date Mfgr Received | 2019-11-01 |
Date Added to Maude | 2019-11-29 |
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 | MARK THAO |
Manufacturer Street | 10675 NAPLES STREET NE |
Manufacturer City | BLAINE MN 55449 |
Manufacturer Country | US |
Manufacturer Postal | 55449 |
Manufacturer Phone | 7634047567 |
Manufacturer G1 | NUVECTRA CORPORATION |
Manufacturer Street | 10675 NAPLES STREET NE |
Manufacturer City | BLAINE MN 55449 |
Manufacturer Country | US |
Manufacturer Postal Code | 55449 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | NUVECTRA CORPORATION |
Generic Name | STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) |
Product Code | LGW |
Date Received | 2019-11-29 |
Model Number | 2408 |
Catalog Number | 2408 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | NUVECTRA CORPORATION |
Manufacturer Address | 10675 NAPLES STREET NE BLAINE MN 55449 US 55449 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-11-29 |