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	Bacterial Infection (1735); Fluid Discharge (2686)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: product family: dbs-linear leads upn: m365db2202450 model: db-2202-45 serial: (b)(6) batch: (b)(6) udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure to remove the right-sided lead and burr hole cover (bhc) due to infection.The patient experienced fluid discharge at the affected site.Antibiotic therapy was initiated to manage the infection, and cultures were obtained; however, the results were not disclosed.The patient is doing well following the procedure.All explanted components were discarded and will not return for analysis.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure to remove the right-sided lead and burr hole cover (bhc) due to infection.The patient experienced fluid discharge at the affected site.Antibiotic therapy was initiated to manage the infection, and cultures were obtained; however, the results were not disclosed.The patient is doing well following the procedure.All explanted components were discarded and will not return for analysis.
Additional Manufacturer Narrative
Correction to block: h6.Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7112735, udi: (b)(4).

• 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: 22405252
• Report Number: 3006630150-2025-05181
• Device Sequence Number: 9664662
• Product Code: MHY
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802(17)251016(10)32358224
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 11/11/2025

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 Expiration Date: 10/16/2025
• Device Model Number: DB-4600-C
• Device Catalogue Number: DB-4600-C
• Device Lot Number: 32358224
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 11/11/2025
• Date Device Manufactured: 10/17/2023
• 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: 64 YR
• Patient Sex: Female
• Patient Race: White