ACTIVA 37601

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-18 for ACTIVA 37601 manufactured by Medtronic Europe Sarl.

MAUDE Entry Details

Report Number9614453-2019-01978
MDR Report Key8708656
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-06-18
Date of Report2019-06-18
Date of Event2017-10-27
Date Mfgr Received2019-05-29
Device Manufacturer Date2017-02-06
Date Added to Maude2019-06-18
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 EUROPE SARL
Manufacturer StreetROUTE DU MOLLIAU 31 CASE POSTALE
Manufacturer CityTOLOCHENAZ VAUD 1131
Manufacturer CountryCH
Manufacturer Postal Code1131
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACTIVA
Generic NameSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Product CodeMBX
Date Received2019-06-18
Model Number37601
Catalog Number37601
Device Expiration Date2018-07-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC EUROPE SARL
Manufacturer AddressROUTE DU MOLLIAU 31 CASE POSTALE TOLOCHENAZ VAUD 1131 CH 1131


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit 2019-06-18

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