ARTISAN SC-8216-50

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 ARTISAN SC-8216-50 manufactured by Boston Scientific Neuromodulation.

MAUDE Entry Details

Report Number3006630150-2019-06951
MDR Report Key9392024
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-08
Date Mfgr Received2019-11-11
Device Manufacturer Date2018-06-25
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 ContactTALAR TAHMASIAN
Manufacturer Street25155 RYE CANYON LOOP
Manufacturer CityVALENCIA CA 91355
Manufacturer CountryUS
Manufacturer Postal91355
Manufacturer Phone6619494863
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetROAD 698, LOT NO. 12
Manufacturer CityDORADO PR 00646-260
Manufacturer Postal Code00646-2602
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARTISAN
Generic NameSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Product CodeLGW
Date Received2019-11-29
Model NumberSC-8216-50
Catalog NumberSC-8216-50
Lot Number7023473
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC NEUROMODULATION
Manufacturer Address25155 RYE CANYON LOOP VALENCIA CA 91355 US 91355


Patients

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

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