ACTIVA 37601

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-09-06 for ACTIVA 37601 manufactured by Medtronic Neuromodulation.

MAUDE Entry Details

Report Number3007566237-2019-01911
MDR Report Key8970947
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2019-09-06
Date of Report2019-09-10
Date of Event2019-06-12
Date Mfgr Received2019-09-10
Date Added to Maude2019-09-06
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 ContactLISA WOODWARD CLARK
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635263920
Manufacturer G1MEDTRONIC NEUROMODULATION
Manufacturer Street800 53RD AVE NE
Manufacturer CityMINNEAPOLIS MN 554211200
Manufacturer CountryUS
Manufacturer Postal Code554211200
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACTIVA
Generic NameIMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
Product CodeMRU
Date Received2019-09-06
Model Number37601
Catalog Number37601
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NEUROMODULATION
Manufacturer Address800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-09-06

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