MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Vercise Genus?; stimulator, electrical, implanted, for parkinsonian tremor

Model Number	DB-1216
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Intermittent Energy Output (4025)
Health Effect - Clinical Codes	Chest Pain (1776); Fatigue (1849); Balance Problems (4401); Paresthesia (4421); Insufficient Information (4580); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced episodes of intermittent stimulation caused by the implantable pulse generator (ipg), this was noticed when the patient was lying in bed.The patient indicated that this episode recurred on three more different times, and stimulation resumed immediately.The patient reported a sensation consistent with an increase in stimulation, resulting in a tingling sensation, unsteady walking and a vibrating sensation in the left side; however, at a later date the patient perceived the vibrating sensation on both sides.This situation caused discomfort and muscle/nerve tension, as the patient felt the muscle lock up for a couple of seconds and then release, causing pain in the chest area when it happened.The vibrating sensation evolved into a zapped sensation with a recurrence every 10 to 15 minutes.The patient reports feeling mentally tired as a consequence of this situation.The patient will undergo a revision procedure at a later stage.
Additional Manufacturer Narrative
D2b: additional pro code selection that applies to the indication of this device - .

• Brand Name: Vercise Genus?
• Common Device Name: stimulator, electrical, implanted, for parkinsonian tremor
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50920291
• Report Number: 3006630150-2026-07165
• Device Sequence Number: 5393707
• Product Code: MHY
• UDI-Device Identifier: 08714729985044
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/09/2024
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 538645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 04/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Male