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

Model Number	DB-1432
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pocket Erosion (2013); Impaired Healing (2378)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: additional pro code selection that applies to the indication of this device .
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced impaired healing at the incision site and it was discovered by the physician that the implantable pulse generator (ipg) had eroded through the skin.Therefore, the patient underwent a revision procedure during which the ipg was explanted and replaced.The patient was stable postoperatively.The explanted ipg will not be returned as it was retained by the medical facility.
Additional Manufacturer Narrative
Block d2b: additional pro code selection that applies to the indication of this device .The device was not returned for analysis as it was retained by the medical facility.As such, physical analysis was unable to be performed.However, it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Review of the instructions for use (ifu) confirmed the implanted device components may wear through the skin which can lead to the need for additional surgery.Additionally, the ifu states poor healing is also a known risk with use of dbs.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced impaired healing at the incision site and it was discovered by the physician that the implantable pulse generator (ipg) had eroded through the skin.Therefore, the patient underwent a revision procedure during which the ipg was explanted and replaced.The patient was stable postoperatively.The explanted ipg will not be returned as it was retained by the medical facility.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24274099
• Report Number: 3006630150-2026-00730
• Device Sequence Number: 10725887
• Product Code: MHY
• UDI-Device Identifier: 08714729985037
• UDI-Public: (01)08714729985037(17)270715(10)240095
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DB-1432
• Device Catalogue Number: DB-1432
• Device Lot Number: 240095
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/02/2026
• Date Device Manufactured: 07/15/2025
• 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: 64 YR
• Patient Sex: Male