VERCISE CARTESIA DB-2202-45

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-01-23 for VERCISE CARTESIA DB-2202-45 manufactured by Boston Scientific Neuromodulation.

Event Text Entries

[176077789] Date of birth - (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[176077790] It was reported that the vercise cartesia directional lead was implanted. The patient later experienced a life threatening seizure. The patient was admitted to the hospital on the same day the reported event occurred and was treated with lacosamide. The patient recovered and was later discharged.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006630150-2020-00161
MDR Report Key9622659
Report SourceFOREIGN,HEALTH PROFESSIONAL,S
Date Received2020-01-23
Date of Report2020-03-12
Date of Event2019-12-25
Date Mfgr Received2020-03-10
Device Manufacturer Date2018-03-12
Date Added to Maude2020-01-23
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 CountryRQ
Manufacturer Postal Code00646-2602
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVERCISE CARTESIA
Generic NameSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Product CodeNHL
Date Received2020-01-23
Model NumberDB-2202-45
Catalog NumberDB-2202-45
Lot Number5027120
Device Expiration Date2020-03-12
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
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. Hospitalization; 2. Required No Informationntervention 2020-01-23

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