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); Purulent Discharge (1812); Unspecified Infection (1930)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: date of event - approximately sometime after 23sep2025 - exact event date is unknown.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2203450, model: db-2203-45, serial: (b)(6), batch: 5002773, udi: (b)(4).Product family: dbs-linear leads, upn: m365db2203450, model: db-2203-45, serial: (b)(6), batch: 5002773, udi: (b)(4).Prodfuct family: dbs-extension, upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: 5001669, udi: (b)(4).Product family: dbs-extension, upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: 5001666, udi: (b)(4).Product family: dbs-ipg-pc, upn: m365db14320, model: db-1432, serial: (b)(6), batch: 236096, udi: (b)(4).Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600-c, serial: na , batch: 36188567, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced an infection at the incision sites on the head where the burr hole covers were implanted.The patient underwent a revision procedure where the full dbs system was explanted.The explanted devices were discarded by the medical facility and were not returned.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced an infection at the incision sites on the head where the burr hole covers were implanted.The patient underwent a revision procedure where the full dbs system was explanted.The explanted devices were discarded by the medical facility and were not returned.Additional information was received that indicated the patient experienced purulent drainage from the right frontal wound.The patient underwent a left frontal wound washout in attempt to prevent explanting the dbs system a few days prior to the explant procedure.The patient was diagnosed with corynebacterium bovis infection.The patient was administered antibiotics.The patient was doing well postoperatively.The correct event date and explant date were also provided.

• 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: 23660816
• Report Number: 3006630150-2025-10871
• Device Sequence Number: 21100346
• Product Code: PJS
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802(17)270402(10)36150611
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: 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): 12/18/2025

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 Model Number: DB-4600-C
• Device Catalogue Number: DB-4600-C
• Device Lot Number: 36150611
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/18/2025
• Date Device Manufactured: 04/02/2025
• 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: Female