ACTIVA 3387

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 2020-03-26 for ACTIVA 3387 manufactured by Medtronic Neuromodulation.

Event Text Entries

[185892252] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185892253] It was reported the dbs lead strayed into the brain and the silicon of the lead wire was torn. The impedance was 4000 ohms. An intervention, to reposition the lead, was scheduled. No factors were known to have led or contributed to the issue. No diagnostics/troubleshooting was performed. A removal of the lead occurred and the lead was re-implanted on (b)(6) 2020. The issue was resolved at the time of the report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000030-2020-00155
MDR Report Key9885284
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-09
Date Mfgr Received2020-03-10
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 CityMINNEAPOLIS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACTIVA
Generic NameSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Product CodeMHY
Date Received2020-03-26
Returned To Mfg2020-03-18
Model Number3387
Catalog Number3387
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NEUROMODULATION
Manufacturer AddressMINNEAPOLIS


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-26

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