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	Cardiac Arrest (1762)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: additional pro code selection that applies to the indication of this device .
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced cardiac arrest during an implant procedure after the burr hole cover was implanted.Resuscitation was performed successfully, the incision wound was closed and the dbs procedure was discontinued.The physician assessed that the event was likely patient-caused and not device related.There were no further reported patient complications postoperatively and the dbs implantation procedure is planned to be performed again in the future.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced cardiac arrest during an implant procedure after the burr hole cover was implanted.Resuscitation was performed successfully, the incision wound was closed and the dbs procedure was discontinued.The physician assessed that the event was likely patient-caused and not device related.There were no further reported patient complications postoperatively and the dbs implantation procedure is planned to be performed again in the future.
Additional Manufacturer Narrative
The device was not returned for analysis as it remains implanted in the patient.As such, physical analysis was unable to be performed.However, it was confirmed these devices met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to patient condition.Block d2b: additional pro code selection that applies to the indication of this device .

• 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: 24401746
• Report Number: 3006630150-2026-01029
• Device Sequence Number: 8168278
• Product Code: MHY
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802(17)270717(10)36907766
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 36907766
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/11/2026
• Date Device Manufactured: 07/17/2025
• 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: Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Unknown