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

Model Number	DB-1200-S
Medical Device Problem Codes	High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631); Intermittent Energy Output (4025)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Shaking/Tremors (2515)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-adapters, upn: m365db9218150, model: db-9218-15, serial: (b)(6), batch: 7053508, udi: (b)(4).Product family: dbs-adapters, upn: m365db9218150, model: db-9218-15, serial: (b)(6), batch: 7053526, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced inadequate stimulation, intermittent stimulation and overstimulation randomly when the device was turned on.High impedance readings were discovered on the non-boston scientific left lead however it could not be determined if the high impedance came from the non-boston scientific lead and lead extension or the boston scientific ipg and adapters.Therefore, the patient underwent a revision procedure during which the boston scientific ipg and adapters were explanted and replaced with a non-boston scientific ipg.The patient was doing well postoperatively.The explanted devices will not be returned as they were discarded by the medical facility.

• Brand Name: VERCISE GEVIA?
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22790118
• Report Number: 3006630150-2025-06435
• Device Sequence Number: 12840813
• Product Code: MHY
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)210519(10)738545
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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: 05/19/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 738545
• 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: 07/21/2025
• Initial Report FDA Received Date: 08/12/2025
• Date Device Manufactured: 05/20/2019
• 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: 59 YR
• Patient Sex: Male