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

Model Number	DB-4605-C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Impaired Healing (2378)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient's incision at the burr hole cover (bhc) site did not appear to be healing appropriately.Signs of infection were noted at the incision site, and the patient exhibited purulent discharge.The physicians performed a debridement and initiated antibiotic therapy.The physician ordered bloodwork to confirm whether the infection was limited to the external site; however, results have not been reported.At the most recent appointment, the patient was noted to be doing well with therapy.The bhc will not be returned to boston scientific, as it remains implanted in the patient.
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A labeling review did not reveal any anomalies and states that infection and implant site complications such as pain, poor healing, redness, warmth, swelling or wound reopening are a known risks with the use of deep brain stimulation.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient's incision at the burr hole cover (bhc) site did not appear to be healing appropriately.Signs of infection were noted at the incision site, and the patient exhibited purulent discharge.The physicians performed a debridement and initiated antibiotic therapy.The physician ordered bloodwork to confirm whether the infection was limited to the external site; however, results have not been reported.At the most recent appointment, the patient was noted to be doing well with therapy.The bhc will not be returned to boston scientific, as it remains implanted in the patient.

• 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: 24599142
• Report Number: 3006630150-2026-01493
• Device Sequence Number: 9561087
• Product Code: PJS
• UDI-Device Identifier: 08714729820819
• UDI-Public: (01)08714729820819(17)270625(10)36837855
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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-4605-C
• Device Catalogue Number: DB-4605-C
• Device Lot Number: 36837855
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 06/25/2025
• 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
• Patient Race: White