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

Model Number	DB-1416
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this deep brain stimulation (dbs) device was explanted due to end of life (eol).The device was retained by the facility and will not be returned for analysis.Postoperatively, patient was reported to be doing well.
Additional Manufacturer Narrative
This report was impacted by emdr scheduled maintenance occurring (b)(6) 2026.D2b: additional pro code selection that applies to the indication of this device: nhl, pjs.
Additional Manufacturer Narrative
This report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.D2b: additional pro code selection that applies to the indication of this device: nhl, pjs.The device was not returned for analysis; therefore, the reported allegation could not be confirmed.A review of the device history record (dhr) verified that the device met all acceptance and release requirements prior to distribution, with no manufacturing-related nonconformances or deviations identified.Product labeling states that an end of service (eos) or elective replacement indicator (eri) message may occur when the battery reaches the end of its service life and may require device replacement.The reported device explantation was considered a secondary outcome of the reported event.A similar complaint review for eos and eri messages found no emerging trends or meaningful commonalities.Based on the available information, no objective evidence was identified to confirm the allegation or determine a probable cause; therefore, the investigation conclusion was cause not established.
Event or Problem Description
It was reported that this deep brain stimulation (dbs) device was explanted due to end of life (eol).The device was retained by the facility and will not be returned for analysis.Postoperatively, patient was reported to be doing well.Additional information was received indicating that the patient's device had reached end of life (eol), resulting in battery shutdown.The device displayed both the elective replacement indicator (eri) and end of battery life (eol) messages.The patient was reported to be a high-frequency user.

• 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 PR ; PR
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25883961
• Report Number: 3006630150-2026-05109
• Device Sequence Number: 9967219
• Product Code: MHY
• UDI-Device Identifier: 08714729985020
• UDI-Public: (01)08714729985020(17)251220(10)224889
• 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: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2026

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: 12/20/2025
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 224889
• 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: 07/01/2026
• Supplement Date Received by Manufacturer: 07/21/2026; 08/21/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 08/18/2026; 09/16/2026
• Date Device Manufactured: 12/21/2023
• 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: 84 YR
• Patient Sex: Unknown