IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR

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 IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.

Event Text Entries

[185093282] Device was used for an off label indication. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185093283] It was reported that the patient began experiencing seizures. The hcp is meeting with the patient to assess the symptoms. The patient was implanted in the anterior cingulate cortex (acc) for the treatment of chronic pain.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2182207-2020-00071
MDR Report Key9884843
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date Mfgr Received2020-03-03
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
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 Street7000 CENTRAL AVE NE
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal Code55432
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMPLANTABLE NEUROSTIMULATOR
Generic NameSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Product CodeMHY
Date Received2020-03-26
Model NumberNEU_INS_STIMULATOR
Catalog NumberNEU_INS_STIMULATOR
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NEUROMODULATION
Manufacturer Address7000 CENTRAL AVE NE MINNEAPOLIS MN 55432 US 55432


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.