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

Model Number	DB-1416
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, based off bsc aware date.Block d2b: additional pro code selection that applies to the indication of this device nhl.The ipg was not returned for analysis; therefore, a technical analysis could not be performed.However, it was confirmed the ipg met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the event.Review of the instructions for use (ifu) confirmed the implanted device components may move from the original implanted location which may lead to the need for additional surgery.Based on a thorough review of the reported complaint boston scientific concluded that the probable cause of the event was unable to be established.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure of the implantable pulse generator (ipg) due to ipg migration to the arm.No further information was able to be obtained despite good faith efforts.

• 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 ; EI
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25451642
• Report Number: 3006630150-2026-03963
• Device Sequence Number: 8726232
• Product Code: MHY
• UDI-Device Identifier: 08714729985020
• UDI-Public: (01)08714729985020(17)250123(10)215393
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• 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: 01/23/2025
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 215393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: 06/15/2026; 07/21/2026; Not provided; 09/07/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/10/2026; 08/17/2026; 08/20/2026; 09/28/2026
• Date Device Manufactured: 01/24/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male