NUVECTRA CORPORATION 2408

MAUDE Adverse Event Report

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.

MAUDE Entry Details

Report Number3010309840-2019-00241
MDR Report Key9392008
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-01
Date Mfgr Received2019-11-01
Date Added to Maude2019-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMARK THAO
Manufacturer Street10675 NAPLES STREET NE
Manufacturer CityBLAINE MN 55449
Manufacturer CountryUS
Manufacturer Postal55449
Manufacturer Phone7634047567
Manufacturer G1NUVECTRA CORPORATION
Manufacturer Street10675 NAPLES STREET NE
Manufacturer CityBLAINE MN 55449
Manufacturer CountryUS
Manufacturer Postal Code55449
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNUVECTRA CORPORATION
Generic NameSTIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF)
Product CodeLGW
Date Received2019-11-29
Model Number2408
Catalog Number2408
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNUVECTRA CORPORATION
Manufacturer Address10675 NAPLES STREET NE BLAINE MN 55449 US 55449


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-29

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