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

Model Number	DB-9218-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) clinical patient enrolled in a4010 study experienced a moderate worsening of parkinson symptoms of rigidity and bradykinesia on the right side.The patient was admitted to the hospital and the device was reprogrammed.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-adapters upn: m365db9218150, model: db-9218-15, serial: (b)(6), batch: 7073352.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) clinical patient enrolled in (b)(6) study experienced a moderate worsening of parkinson symptoms of rigidity and bradykinesia on the right side.The patient was admitted to the hospital and the device was reprogrammed.Additional information was received that the patient underwent a revision procedure where the dbs pocket adapters were replaced.The event has resolved.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) clinical patient enrolled in a4010 study experienced a moderate worsening of parkinson symptoms of rigidity and bradykinesia on the right side.The patient was admitted to the hospital and the device was reprogrammed.Additional information was received that the patient underwent a revision procedure where the dbs pocket adapters were replaced.The event has resolved.Additional information was received indicating that the potential relationship to study stimulation is not related and potential relationship to device hardware is probable.

• Brand Name: VERCISE
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17221507
• Report Number: 3006630150-2023-03725
• Device Sequence Number: 19588898
• Product Code: MHY
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2025

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: 01/21/2024
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 7073557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 11/13/2025
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/04/2023; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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 Sex: Unknown