VERCISE CARTESIA DB-2202-30

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 2019-11-21 for VERCISE CARTESIA DB-2202-30 manufactured by Boston Scientific Neuromodulation.

MAUDE Entry Details

• Report Number: 3006630150-2019-06713
• MDR Report Key: 9359707
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-11-21
• Date of Report: 2019-11-21
• Date of Event: 2019-04-12
• Date Mfgr Received: 2019-11-05
• Device Manufacturer Date: 2018-03-08
• Date Added to Maude: 2019-11-21
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: TALAR TAHMASIAN
• Manufacturer Street: 25155 RYE CANYON LOOP
• Manufacturer City: VALENCIA CA 91355
• Manufacturer Country: US
• Manufacturer Postal: 91355
• Manufacturer Phone: 6619494863
• Manufacturer G1: BOSTON SCIENTIFIC CORPORATION
• Manufacturer Street: ROAD 698, LOT NO. 12
• Manufacturer City: DORADO PR 00646-260
• Manufacturer Postal Code: 00646-2602
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VERCISE CARTESIA
• Generic Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Product Code: NHL
• Date Received: 2019-11-21
• Model Number: DB-2202-30
• Catalog Number: DB-2202-30
• Lot Number: 5027472
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
• Manufacturer Address: 25155 RYE CANYON LOOP VALENCIA CA 91355 US 91355

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-11-21