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

Model Number	DB-1110-C
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyskinesia (2363); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the patient with a deep brain stimulation (dbs) system underwent an explant procedure for an unspecified reason.No additional information is available at this time.
Event or Problem Description
It was reported that the patient with a deep brain stimulation (dbs) system underwent an explant procedure for an unspecified reason.No additional information is available at this time.Additional information was received stating that the dbs implantable pulse generator (ipg) was replaced due to inadequate stimulation, as a consequence, the patient experienced troublesome dyskinesia.The ipg was retained by the facility and will not be returned for analysis.Postoperatively, the patient was doing good.
Additional Manufacturer Narrative
Correction to the supplemental mdr in h6.
Event or Problem Description
It was reported that the patient with a deep brain stimulation (dbs) system underwent an explant procedure for an unspecified reason.No additional information is available at this time.Additional information was received stating that the dbs implantable pulse generator (ipg) was replaced due to inadequate stimulation, as a consequence, the patient experienced troublesome dyskinesia.The ipg was retained by the facility and will not be returned for analysis.Postoperatively, the patient was doing good.

• 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: 23297358
• Report Number: 3006630150-2025-08892
• Device Sequence Number: 17340126
• Product Code: NHL
• UDI-Device Identifier: 08714729820758
• UDI-Public: (01)08714729820758(17)190831(10)2000022122
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 11/17/2025

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: 08/31/2019
• Device Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• Device Lot Number: 2000022122
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 10/13/2025; 11/05/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/04/2025; 11/17/2025
• Date Device Manufactured: 08/31/2017
• 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: 55 YR
• Patient Sex: Male