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

Model Number	DB-9218-15
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) clinical patient enrolled in clinical study a4010 developed moderate worsening of parkinson's symptoms on the left side.High impedances measurements were discovered on the dbs pocket adaptor.The patient was treated with medication and the device was reprogrammed.The event resolved (b)(6) 2022.This reported event has a causal relationship to stimulation and hardware.
Additional Manufacturer Narrative
Correction to field b5 - correction to initial report, as the patient's moderate worsening of parkinson's symptoms were on the right side, not on the left side as originally reported.Update to field h6 impact codes.Additional suspect medical device components involved in the event: product family: scs-adapters, upn: m365sc9218150, model: sc-9218-15, serial: (b)(6), batch: (b)(6).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) clinical patient enrolled in clinical study a4010 developed moderate worsening of parkinson's symptoms on the left side.High impedance measurements were discovered on the dbs pocket adaptor.The patient was treated with medication and the device was reprogrammed.The event resolved on (b)(6) 2022.This event was reported as a causal relationship to stimulation and hardware.Additional information was received on 21feb2023 indicating that the patient underwent a revision procedure where two dbs pocket adaptors were explanted and replaced.The patient was doing well post-operatively.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) clinical patient enrolled in clinical study a4010 developed moderate worsening of parkinson's symptoms on the left side.High impedance measurements were discovered on the dbs pocket adaptor.The patient was treated with medication, and the device was reprogrammed.The event resolved on (b)(6) 2022.This event was reported as a causal relationship to stimulation and hardware.Additional information was received on 21feb2023 indicating that the patient underwent a revision procedure where two dbs pocket adaptors were explanted and replaced.The patient was doing well post-operatively.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: 15904862
• Report Number: 3006630150-2022-06700
• Device Sequence Number: 14961065
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,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: 01/24/2024
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 7073563
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 02/21/2023; 11/13/2025
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 03/07/2023; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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