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

Model Number	DB-3128-55
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Codes	Fatigue (1849); Undesired Nerve Stimulation (1980); Pain (1994); Movement Disorder (4412)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced body fatigue, pain, inadequate therapy on their left torso and felt the implantable pulse generator (ipg) rotate in pocket site.Functional testing revealed a high impedance contact that was reprogrammed around resulting with adequate therapy and patient symptoms residing.The physician assessed that the patients symptoms were exacerbated while the dbs therapy was on however resided once reprogrammed.The patient underwent a procedure wherein the ipg was repositioned and secured in the pocket site and additional functional testing confirmed high impedance on the lead extension as a result was replaced with another of the same model before completing the procedure.The patient did well post-operatively.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-ipg-r-mri, upn: m365db12160, model: db-1216, serial: unk, batch: unk.
Additional Manufacturer Narrative
The returned deep brain stimulation (dbs) vercise lead extension was analyzed and could not confirm the reported allegation with testing of the device.Visual inspection revealed that the dbs lead extension was cleanly cut into two pieces approximately 45 cm from the proximal end.The clean-cut damage is a result of a typical explant procedure, and it is not considered a failure.The lead passed x-ray inspection and the dimensional test.An electrical test could not be performed due to the cut lead body.No other anomalies were identified during the product analysis.A product labeling review identified that the device was used per the instructions for use (ifu) product label.Additionally, labeling identifies several known risks associated with deep brain stimulation (dbs), including but not limited to: battery leakage or failure, lead or lead extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits, and lead insulation breaches.These issues may or may not require device removal or replacement.Labeling additionally notes potential patient-related effects such as weakness, muscle spasms, tremors, restlessness, movement disorders, loss of adequate stimulation, and undesirable sensations (e.G., tingling).Based on all available information, engineering analysis of the returned product did not confirm the reported high impedance.As a result, the most probable cause was attributed to a known inherent risk associated with the device.Additional suspect medical device components involved in the event: product family: dbs-ipg-r-mri upn: m365db12160 model: db-1216 serial: (b)(6) batch: 5002863 udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced body fatigue, pain, inadequate therapy on their left torso and felt the implantable pulse generator (ipg) rotate in pocket site.Functional testing revealed a high impedance contact that was reprogrammed around resulting with adequate therapy and patient symptoms residing.The physician assessed that the patients symptoms were exacerbated while the dbs therapy was on however resided once reprogrammed.The patient underwent a procedure wherein the ipg was repositioned and secured in the pocket site and additional functional testing confirmed high impedance on the lead extension as a result was replaced with another of the same model before completing the procedure.The patient did well post-operatively.Additional information provided the model and serial number of the implantable pulse generator (ipg).

• Brand Name: VERCISE
• 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; 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: 22214311
• Report Number: 3006630150-2025-04459
• Device Sequence Number: 8619915
• Product Code: NHL
• UDI-Device Identifier: 08714729966371
• UDI-Public: (01)08714729966371(17)260116(10)5002863
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: 01/16/2026
• Device Model Number: DB-3128-55
• Device Catalogue Number: DB-3128-55
• Device Lot Number: 5002863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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