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

Model Number DB-1416

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

Patient Problems Fall (1848); Blurred Vision (2137); Dizziness (2194); Movement Disorder (4412); Speech Disorder (4415); Ischemia Stroke (4418)

Event Date 04/22/2023

Event Type  Injury  

Event Description

It was reported the patient experienced dizziness and imbalance, difficulty speaking, and blurred vision.Efforts to adjust stimulation, including turning stimulation off were unsuccessful.The patient was admitted to the hospital where a computed tomography (ct) scan revealed no anomalies; however, magnetic resonance imaging (mri) revealed the patient had a minor stroke below the thalamus.The physician assessed the cause of the patient symptoms were a result of the stroke and that the stroke was not device related.It was also noted that the patient had surgery on their jaw in (b)(6) 2023 and a fall a few weeks prior to the event.The physician indicated it was highly doubtful that the device directly influenced the fall despite the fact that the event occurred close to when the device was turned on.The patient was discharged from the hospital and was doing well.

• 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: 16956460
• MDR Text Key: 315529048
• Report Number: 3006630150-2023-02821
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985020
• UDI-Public: 08714729985020
• 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
• Report Date: 05/18/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2023
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 202510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2023
• Initial Date FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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
• Patient Age: 67 YR