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); Head Injury (1879); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient sustained trauma to the right side of the head, resulting in bleeding at the implant site.After the bleeding resolved, the patient did not report any additional symptoms or concerns.During a subsequent programming visit, examination revealed exposure of the deep brain stimulation (dbs) burr hole cap, while the surrounding tissue appeared healed.No additional adverse patient effects were reported.As part of the intervention, the finding was communicated to the treating neurologist, who initiated an urgent referral to the neurosurgeon for evaluation and wound revision.The neurosurgeon's office was also notified to facilitate follow-up.At the time of reporting, the patient had been referred for surgical evaluation, and no further patient status information was available.The dbs system remained implanted pending evaluation.Information regarding device return or analysis was not applicable at the time of the report.
Additional Manufacturer Narrative
B3: approximated one month prior the manufacturer became aware of the event block d.2b; additional applicable product codes: nhl, pjs.

• 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: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50255877
• Report Number: 3006630150-2026-05893
• Device Sequence Number: 18673238
• Product Code: MHY
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802(17)270709(10)36866659
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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-4600-C
• Device Catalogue Number: DB-4600-C
• Device Lot Number: 36866659
• 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: 07/24/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 07/09/2025
• 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: Other
• Patient Age: 81 YR
• Patient Sex: Female