MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS¿; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-1232

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 11/02/2021

Event Type  Injury  

Event Description

It was reported the patient experienced atypical chest pain the day of the deep brain stimulation (dbs) procedure.The patient was given one time sublingual nitroglycerine spray resolving the reported event.The physician assessed the event to have a probable relation to the procedure, and not related to the device or stimulation.

Event Description

It was reported the patient experienced atypical chest pain the day of the deep brain stimulation (dbs) procedure.The patient was given one time sublingual nitroglycerine spray resolving the reported event.The physician assessed the event to have a probable relation to the procedure, and not related to the device or stimulation.Additional information received clarified the patient experienced the reported chest pain before the implant procedure.The procedure was then postponed, and the patient was implanted approximately three weeks later.

• Brand Name: VERCISE GENUS¿
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12929931
• MDR Text Key: 281731633
• Report Number: 3006630150-2021-06926
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985051
• UDI-Public: 08714729985051
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/20/2022
• Device Model Number: DB-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 501893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male