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

Model Number	DB-1110-C
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
The deep brain stimulation (dbs) implantable pulse generator (ipg) was replaced due to increased charging duration.Attempts at charging reeducation were unsuccessful.No weight changes were reported that could have contributed to the issue.The patient underwent an ipg revision procedure in which the ipg was explanted and replaced.Electrocautery was utilized during the procedure.The hospital disposed of the explanted device, and it will not be returned for analysis.The patient is reported to be doing well, with no postoperative complications reported.
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.The device was not returned to boston scientific for analysis.However, a review of the device history record (dhr) confirmed that the device met specification prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable cause for the complaint and the conclusion code: cause not established will be used.
Event or Problem Description
The deep brain stimulation (dbs) implantable pulse generator (ipg) was replaced due to increased charging duration.Attempts at charging reeducation were unsuccessful.No weight changes were reported that could have contributed to the issue.The patient underwent an ipg revision procedure in which the ipg was explanted and replaced.Electrocautery was utilized during the procedure.The hospital disposed of the explanted device, and it will not be returned for analysis.The patient is reported to be doing well, with no postoperative complications reported.

• Brand Name: VERCISE?
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24563734
• Report Number: 3006630150-2026-01401
• Device Sequence Number: 8829013
• Product Code: NHL
• UDI-Device Identifier: 08714729820758
• UDI-Public: (01)08714729820758(17)191011(10)21239744
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 04/24/2026

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: 10/11/2019
• Device Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• Device Lot Number: 21239744
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 10/11/2017
• 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: 72 YR
• Patient Sex: Male