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

Model Number	DB-3216-55
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced erosion at the extension site where it connects to the lead, resulting in exposure of the lead extension.The patient subsequently underwent a revision procedure where the lead extensions were replaced.The patient was doing well postoperatively.The explanted devices were disposed of at the facility and were not returned.
Additional Manufacturer Narrative
Block b3 date of event: approximated based on the date the manufacturer became aware of the event as the patient was not certain of the exact event date.Additional suspect medical device component involved in the event: model: db-3216-55, serial: (b)(6), batch: 5002918, catalog description: argyle extension 55 cm sterile kit, udi: (b)(4).
Additional Manufacturer Narrative
A review of the manufacturing records associated with these devices indicated that they were successfully processed according to requirements.The dhr did not identify any manufacturing process-related non-conformances, scrap, or rework performed during production that could have caused or contributed to this event.The dhr review ensures each device meets required specifications and associated testing prior to release for distribution/sale.The devices were not returned as they were disposed of by the medical facility.As such, physical analysis has not been conducted in our laboratory.A labelling review was performed based on dfu and it did not reveal any anomalies as it states: implanted device components (stimulator, lead, or lead extension) may move from original location or wear through the skin, which may lead to the need for additional surgery and is a known risk with the use of deep brain stimulation (dbs).The devices were not returned as they were disposed of by the medical facility.As such, physical analysis has not been conducted in our laboratory.However, a labeling review was conducted.This review determined that the reported event of erosion is a known inherent risk with the use of deep brain stimulation (dbs).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced erosion at the extension site where it connects to the lead, resulting in exposure of the lead extension.The patient subsequently underwent a revision procedure where the lead extensions were replaced.The patient was doing well postoperatively.The explanted devices were disposed of at the facility and were not returned.

• 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: 24769514
• Report Number: 3006630150-2026-02017
• Device Sequence Number: 9247960
• Product Code: NHL
• UDI-Device Identifier: 08714729966395
• UDI-Public: (01)08714729966395(17)270730(10)5002996
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/14/2026

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-3216-55
• Device Catalogue Number: DB-3216-55
• Device Lot Number: 5002996
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 07/30/2025
• 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
• Patient Age: 73 YR
• Patient Sex: Female