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 Problem Chest Pain (1776)

Event Date 10/26/2023

Event Type  Injury  

Event Description

It was reported that after the patient completed charging their implantable pulse generator (ipg), the patient stood up and felt a sharp pain at the ipg site on her chest.The patient had an xray and the ipg appeared to be positioned correctly.The patients primary care physician administered medication to the patient for the pain.The stimulation settings have been adjusted however this has not relieved the patients pain.A database analysis was performed an no anomalies were found.The patient stated that when they turned off the stimulation the pain subsided and when stimulation was turned back on, the pain returned.The patient underwent a procedure where the ipg was explanted and replaced.Post-operatively, the patient appeared to be recovering as expected.A few days following the procedure, the patient reported that the chest pain had resolved.

Event Description

It was reported that after the patient completed charging their implantable pulse generator (ipg), the patient stood up and felt a sharp pain at the ipg site on her chest.The patient had an xray and the ipg appeared to be positioned correctly.The patients primary care physician administered medication to the patient for the pain.The stimulation settings have been adjusted however this has not relieved the patients pain.A database analysis was performed an no anomalies were found.The patient stated that when they turned off the stimulation the pain subsided and when stimulation was turned back on, the pain returned.The patient underwent a procedure where the ipg was explanted and replaced.Post-operatively, the patient appeared to be recovering as expected.A few days following the procedure, the patient reported that the chest pain had resolved.

Manufacturer Narrative

The returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.Pain or discomfort are a known risk with the use of deep brain stimulation.

• 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: 18221078
• MDR Text Key: 329162028
• Report Number: 3006630150-2023-07404
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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 Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 558377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female