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	Erosion (1750)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced erosion at the burr hole cover, of the deep brain stimulation (dbs) system, left scalp site completely exposing the burr hole cover.The patient underwent a procedure in which all the devices were explanted, to reduce the risk of infection, with a flap revision closure of the site.The physician could not confirm whether the device was the cause of the erosion or whether the patient picked at the site and caused the wound to open.Cultures were taken during the procedure; however, the results of the culture and whether an infection was confirmed were not provided due to facility policy.The patient was prescribed antibiotics and doing well post operatively, with tremors at baseline.The devices will not be returned as they were disposed of by the facility.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: db-4600-c.Serial number: n/a.Batch/lot number: 30042548.Model/catalog description: suretek burr hole cover kit.Unique identifier (udi) # (b)(4) model number/catalog number: db-2202-45.Serial number: (b)(6) batch/lot number: 7103287 and 7097288.Model/catalog description: dbs directional lead sterile kit 45cm.Unique identifier (udi) # (b)(4) model number/catalog number: db-1200-s.Serial number: (b)(6) batch/lot number: 740452.Model/catalog description: vercis gevia implantable pulse generator kit.Unique identifier (udi) #(b)(4) model number/catalog number: nm-3138-55.Serial number: (b)(6) batch/lot number: 7097045; 7060335 and 7113434.Model/catalog description: 55cm 8 contact extension.Unique identifier (udi) #(b)(4) model number/catalog number: sc-4401.Serial number: n/a.Batch/lot number: 27206554.Model/catalog description: precision spectra ipg port plug.Unique identifier (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 -579
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292-0920
• MDR Report Key: 50288809
• Report Number: 3006630150-2026-05979
• Device Sequence Number: 13181250
• Product Code: PJS
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802(17)250327(10)31230145
• 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: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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 Expiration Date: 03/26/2025
• Device Model Number: DB-4600-C
• Device Catalogue Number: DB-4600-C
• Device Lot Number: 31230145
• 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: 07/20/2026
• Initial Report FDA Received Date: 08/17/2026
• Date Device Manufactured: 03/27/2023
• 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: 57 YR
• Patient Sex: Female