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

Model Number	DB-9208-15
Medical Device Problem Codes	High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, based off bsc aware date.Additional suspect medical device component involved in the event: product family: dbs-adapters, upn: m365db9208150, model: db-9208-15, serial: (b)(6), batch: 7076933, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced inadequate stimulation which resulted in a return of their parkinson's disease symptoms bradykinesia and rigidity.It was discovered that there were high impedance readings on the non-boston scientific right-sided lead extension.The subpectoral implantable pulse generator (ipg) was palpated by the physician to troubleshoot the issue however, this did not resolve the impedance issue.X-ray imaging was taken which did not reveal any apparent anomalies.Therefore, the patient underwent a revision procedure during which one of the bsc adapters was explanted and replaced which did not resolve the impedance issue.The physician then decided to replace the non-bsc lead extension after which the impedance issue was then resolved and the patient has fully recovered postoperatively.The explanted adapter will not be returned due to hospital policy.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced inadequate stimulation which resulted in a return of their parkinson's disease symptoms bradykinesia and rigidity.It was discovered that there were high impedance readings on the non-boston scientific right-sided lead extension.The subpectoral implantable pulse generator (ipg) was palpated by the physician to troubleshoot the issue however, this did not resolve the impedance issue.X-ray imaging was taken which did not reveal any apparent anomalies.Therefore, the patient underwent a revision procedure during which one of the bsc adapters was explanted and replaced which did not resolve the impedance issue.The physician then decided to replace the non-bsc lead extension after which the impedance issue was then resolved and the patient has fully recovered postoperatively.The explanted adapter will not be returned due to hospital policy.
Additional Manufacturer Narrative
Correction to block h6: device code.The device was not returned for analysis as it was retained by the medical facility.As such, physical analysis was unable to be performed.However, it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Block b3: exact date unknown, based off bsc aware date.Additional suspect medical device component involved in the event: model number/catalog number: db-9208-15, serial number: (b)(6), batch/lot number: 7076933, model/catalog description: vercise s8 adapter dbs 15 cm, unique identifier (udi) #: (b)(4).

• 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: 24384403
• Report Number: 3006630150-2026-00982
• Device Sequence Number: 18771183
• Product Code: NHL
• UDI-Device Identifier: 00191506014339
• UDI-Public: (01)00191506014339(17)271007(10)7076977
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• 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): 04/02/2026

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 Model Number: DB-9208-15
• Device Catalogue Number: DB-9208-15
• Device Lot Number: 7076977
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/02/2026
• Date Device Manufactured: 10/07/2025
• 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; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male