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

Model Number	DB-2201-45DC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Convulsion/Seizure (4406); Insufficient Information (4580)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro code selection that applies to the indication of this device .
Event or Problem Description
It was reported that the patient developed a cyst around the right brain lead implant, which was identified through imaging.Additionally, the patient was recently hospitalized due to new seizures.The physician was unable to confirm whether these seizures were caused by or related to the cyst.The physician will continue monitoring the patient to determine if the cyst increases in size.
Event or Problem Description
It was reported that the patient developed a cyst around the right brain lead implant, which was identified through imaging.Additionally, the patient was recently hospitalized due to new seizures.The physician was unable to confirm whether these seizures were caused by or related to the cyst.The physician will continue monitoring the patient to determine if the cyst increases in size.
Additional Manufacturer Narrative
The device db 2201 45dc, serial number (b)(6), was not returned to boston scientific for analysis.As a result, a direct evaluation of the reported complaint could not be performed.A comprehensive labeling review was conducted, and no anomalies were identified.The labeling specifies that intraparenchymal cysts and seizures are recognized risks associated with the use of deep brain stimulation systems.Following a thorough review of the reported complaint and supporting documentation, boston scientific has concluded the investigation and assigned the outcome code: known inherent risk of device.Additional pro code selection that applies to the indication of this device .

• Brand Name: NA
• 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; CS 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24717384
• Report Number: 3006630150-2026-01853
• Device Sequence Number: 17664257
• Product Code: MHY
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DB-2201-45DC
• Device Catalogue Number: DB-2201-45DC
• Device Lot Number: 7076033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 12/16/2024
• 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; Life Threatening; Hospitalization
• Patient Age: 31 YR
• Patient Sex: Male