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

Model Number	DB-1200-S
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Pain (1994); Discomfort (2330); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient undergoing deep brain stimulation (dbs) therapy presented to the emergency department with complaints of a pressure headache and a perceived odor resembling burning wires, which the patient associated with inadequate stimulation.The patient reported persistent head pain and discomfort regardless of whether the stimulation was active or inactive.Upon evaluation, a neurologist confirmed that the dbs device was functioning as intended and concluded that the symptoms were unlikely to be related to the device.Nevertheless, the patient's device was subsequently reprogrammed.Additional diagnostic tests were ordered to further investigate the reported symptoms, though they have not yet been performed.The event remains ongoing.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a patient undergoing deep brain stimulation (dbs) therapy presented to the emergency department with complaints of a pressure headache and a perceived odor resembling burning wires, which the patient associated with inadequate stimulation.The patient reported persistent head pain and discomfort regardless of whether the stimulation was active or inactive.Upon evaluation, a neurologist confirmed that the dbs device was functioning as intended and concluded that the symptoms were unlikely to be related to the device.Nevertheless, the patient's device was subsequently reprogrammed.Additional diagnostic tests were ordered to further investigate the reported symptoms, though they have not yet been performed.The event remains ongoing.Additional information was received that the physician does not believe the patients symptoms were related to the device, but rather attributable to an underlying psychiatric condition.
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 a patient undergoing deep brain stimulation (dbs) therapy presented to the emergency department with complaints of a pressure headache and a perceived odor resembling burning wires, which the patient associated with inadequate stimulation.The patient reported persistent head pain and discomfort regardless of whether the stimulation was active or inactive.Upon evaluation, a neurologist confirmed that the dbs device was functioning as intended and concluded that the symptoms were unlikely to be related to the device.Nevertheless, the patient's device was subsequently reprogrammed.Additional diagnostic tests were ordered to further investigate the reported symptoms, though they have not yet been performed.The event remains ongoing.Additional information was received that the physician does not believe the patients symptoms were related to the device, but rather attributable to an underlying psychiatric condition.Additional information was received that the patient underwent magnetic resonance imaging (mri), which yielded normal findings.

• Brand Name: VERCISE GEVIA?
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22500455
• Report Number: 3006630150-2025-05474
• Device Sequence Number: 7013381
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)210908(10)739925
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/04/2025

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: 09/08/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 739925
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 08/13/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/13/2025; 09/04/2025
• Date Device Manufactured: 09/09/2019
• 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; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Race: White