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	Convulsion/Seizure (4406); Decreased Level of Consciousness (4591)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the deep brain stimulation (dbs) implant procedure after the burr hole cover was implanted the patient became unresponsive and experienced a seizure.The burr hole cover was removed, and the patient was doing well postoperatively.The physician assessed that opening up the hole in the skull to place the bhc caused the patient to lose some of his faculties, not the device itself.The burr hole cover was retained by the medical facility and was not returned.The patient is scheduled to complete the full implant procedure in the very near future.

• 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: 50246170
• Report Number: 3006630150-2026-05898
• Device Sequence Number: 10119108
• Product Code: NHL
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802(17)280513(10)39249500
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: Health Professional
• Device Model Number: DB-4600-C
• Device Catalogue Number: DB-4600-C
• Device Lot Number: 39249500
• 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
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 05/14/2026
• 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: 61 YR
• Patient Sex: Male