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

Model Number	DB-4600-C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b pro code (product code): nhl, pjs.
Event or Problem Description
It was reported that the patient experienced a suspected cerebrospinal fluid (csf) loss and underwent a revision of the burr hole cover in which the burr hole cover clip and cap were removed.The physician decided to fixate the lead using bone cement to prevent csf loss.No device will be returned.
Event or Problem Description
It was reported that the patient experienced a suspected cerebrospinal fluid (csf) loss and underwent a revision of the burr hole cover in which the burr hole cover clip and cap were removed.The physician decided to fixate the lead using bone cement to prevent csf loss.No device will be returned.It was additionally reported that it is unclear as to which of the two implanted leads was involved, and that the removed device was disposed of by the facility.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b pro code (product code): nhl, pjs additional suspect medical device components involved in the event: model number/catalog number: db-2202-45 serial number: (b)(6).Batch/lot number: 7140204 and 7138942 model/catalog description: dbs directional lead sterile kit 45cm unique identifier (udi) # (b)(4).
Event or Problem Description
It was reported that the patient experienced a suspected cerebrospinal fluid (csf) loss and underwent a revision of the burr hole cover in which the burr hole cover clip and cap were removed.The physician decided to fixate the lead using bone cement to prevent csf loss.No device will be returned.It was additionally reported that it is unclear as to which of the two implanted leads was involved, and that the removed device was disposed of by the facility.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b pro code (product code): nhl, pjs.Additional suspect medical device components involved in the event: model number/catalog number: db-2202-45, serial number: (b)(6), batch/lot number: 7140204 and 7138942, model/catalog description: dbs directional lead sterile kit 45cm, unique identifier (udi) # (b)(4).With all the available information, boston scientific concludes that the cause of the patient experiencing a suspected cerebrospinal fluid (csf) loss and undergoing a revision of the burr hole cover was confirmed based on record review, the devices were not returned as they were discarded by the facility.A review of the manufacturing records associated with the device indicated that it was successfully processed according to requirements.The device history review, 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 device was discarded by the facility and not returned for analysis; therefore, a technical analysis could not be performed.A labeling review was performed on the devices' instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.It states brain or cerebral spinal fluid (csf) fluid infection or inflammation is a known risk with the use of deep brain stimulation.Based on all available information, engineers are able to confirm the root cause of the event.The devices were not returned as such physical analysis was not conducted, record review revealed no additional information related to the complaint.Therefore, this investigation is able to determine a probable root cause for the complaint, and the conclusion is known inherent risk of device.

• Brand Name: SURETEK?
• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23970841
• Report Number: 3006630150-2026-00083
• Device Sequence Number: 20794872
• Product Code: PJS
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802(17)270623(10)36754337
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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-4600-C
• Device Catalogue Number: DB-4600-C
• Device Lot Number: 36754337
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 03/17/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/23/2026; 04/07/2026
• Date Device Manufactured: 06/23/2025
• 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: 66 YR
• Patient Sex: Male