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

Model Number DB-1216

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

Patient Problems Inadequate Pain Relief (2388); Movement Disorder (4412)

Event Date 01/07/2023

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient was experiencing a lack of therapy benefit wherein the stimulation output was not sufficiently addressing the patients parkinson's symptoms.Computed tomography scan (ct) and x-ray imaging were performed and ruled out any lead fractures and confirmed lead placement was good.Reprogramming was attempted multiple times with no success.The physician suspected there may have been an issue with the implantable pulse generator (ipg) as the energy output was not sufficiently addressing the patient symptoms.The patient underwent a revision procedure where the ipg was replaced.The patient remained in the hospital to recover post-operatively.

Manufacturer Narrative

The returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.Additionally, a labeling review was performed.This review determined that the reported event of the patient experiencing a lack of therapy benefits wherein the stimulation output was not sufficiently addressing the patients parkinsons symptoms is a known risk of implanting a pulse generator as part of a system to deliver deep brain stimulation.

Event Description

It was reported that the deep brain stimulation (dbs) patient was experiencing a lack of therapy benefit wherein the stimulation output was not sufficiently addressing the patients parkinson's symptoms.Computed tomography scan (ct) and x-ray imaging were performed and ruled out any lead fractures and confirmed lead placement was good.Reprogramming was attempted multiple times with no success.The physician suspected there may have been an issue with the implantable pulse generator (ipg) as the energy output was not sufficiently addressing the patient symptoms.The patient underwent a revision procedure where the ipg was replaced.The patient remained in the hospital to recover post-operatively.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16546980
• MDR Text Key: 311330989
• Report Number: 3006630150-2023-01284
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/31/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/24/2022
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 502340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 03/24/2023
• Supplement Dates FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female