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 Codes	Erosion (1750); Erythema (1840)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced erosion at the burr hole cover site showing signs of redness around the wound.The patient underwent a revision procedure where the wound was cleaned and antibiotics were administered.The patient was doing well postoperatively.
Additional Manufacturer Narrative
Block b3 date of event: approximated based on the date the manufacturer became aware of the event - exact event date is unknown.Additional suspect medical device component involved in the event: model: db-4600-c.Serial: na batch: 37686467.Catalog description: suretek burr hole cover kit.Udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced erosion at the burr hole cover site showing signs of redness around the wound.The patient underwent a revision procedure where the wound was cleaned and antibiotics were administered.The patient was doing well postoperatively.
Additional Manufacturer Narrative
Block b3 date of event: approximated based on the date the manufacturer became aware of the event - exact event date is unknown.Additional suspect medical device component involved in the event: model: db-4600-c serial: na batch: 37686467 catalog description: suretek burr hole cover kit udi: (b)(4).The devices were not returned as they remain implanted in the patient.As such, physical analysis has not been conducted in our laboratory.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.A labelling review was performed based on the dfu and it did not reveal any anomalies as it states implanted device components (stimulator, lead, or lead extension) may move from original implanted location or wear through the skin, which may lead to the need for additional surgery.Additionally, implant site complications such as poor healing, redness, warmth, swelling or wound reopening are known risks with the use of deep brain stimulation (dbs).The devices were not returned as they remain implanted in the patient.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 risk associated with the use of deep brain stimulation (dbs) as documented in the instructions for use (ifu).

• 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: 24619683
• Report Number: 3006630150-2026-01566
• Device Sequence Number: 21366714
• Product Code: PJS
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802(17)251112(10)32585845
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 04/28/2026

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 Expiration Date: 11/12/2025
• Device Model Number: DB-4600-C
• Device Catalogue Number: DB-4600-C
• Device Lot Number: 32585845
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 11/13/2023
• 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: 70 YR
• Patient Sex: Male