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 company representative,health report with the FDA on 2020-03-09 for VERCISE CARTESIA DB-2202-45 manufactured by Boston Scientific Neuromodulation.

Event Text Entries

[182583014] It was reported that following an implant procedure a ct scan was taken and displayed that the lead was not implanted straight. The physician noted that the stylet was difficult to remove and therefore, believes this was the reason the lead was not implanted correctly. The patient underwent a lead replacement procedure and is doing well post operatively.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006630150-2020-01064
MDR Report Key9806380
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-09
Date of Report2020-03-09
Date of Event2020-02-13
Date Mfgr Received2020-02-13
Device Manufacturer Date2019-11-21
Date Added to Maude2020-03-09
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 ContactMS. TALAR 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 Received2020-03-09
Model NumberDB-2202-45
Catalog NumberDB-2202-45
Lot Number7070838
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 2020-03-09

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