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	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) implantable pulse generator (ipg) reached end of service (eos).As part of the intervention, the ipg was replaced.Postoperatively, the patient was reported to have resumed therapy with the replacement ipg and was receiving stimulation as intended.The explanted device will not be returned for analysis, as it was retained and disposed of by the hospital in accordance with facility policy.
Additional Manufacturer Narrative
Block b4: approximated based on the date the manufacturer became aware of the event.Block d.2b; additional applicable product codes: nhl, pjs.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) implantable pulse generator (ipg) reached end of service (eos).As part of the intervention, the ipg was replaced.Postoperatively, the patient was reported to have resumed therapy with the replacement ipg and was receiving stimulation as intended.The explanted device will not be returned for analysis, as it was retained and disposed of by the hospital in accordance with facility policy.
Additional Manufacturer Narrative
Block b4: approximated based on the date the manufacturer became aware of the event.Block d.2b; additional applicable product codes: nhl, pjs.The device was not returned for analysis; therefore, a physical evaluation could not be performed, and the reported allegation was not able to be confirmed.A review of the device history record (dhr) was conducted.The records indicate that the device met all applicable acceptance criteria and release requirements prior to distribution.No manufacturing-related nonconformances or deviations were identified during the review that could be associated with the reported event.A labeling review did not reveal any anomalies as it states: ''when the implanted non-rechargeable stimulator is nearing the end of its battery life, the stimulator will enter the elective replacement mode.The elective replacement indicator (eri) will appear on the remote control and clinician programmer.Labelling also states: ''when the stimulator battery is fully depleted, the end of service (eos) indicator will be displayed on the remote control and clinician programmer.Stimulation will not be available.Surgery is required to replace the implanted non-rechargeable stimulator to continue providing stimulation.'' a similar complaint review was completed using similar complaint review tool (b)(4) which reviewed 5334: ipg - 2022: message - received end of battery life message.The review did not identify any emerging trends, meaningful commonalities, or similar complaints requiring escalation.Therefore, no additional escalation is required.Therefore, in the absence of device return and analysis the likely root cause could not be established.

• 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: 50063893
• Report Number: 3006630150-2026-05329
• Device Sequence Number: 13433805
• Product Code: MHY
• UDI-Device Identifier: 08714729985020
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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 Expiration Date: 08/29/2026
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 230881
• 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: 07/01/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 08/29/2024
• 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: 51 YR
• Patient Sex: Male