MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SURETEK?; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	DB-4600-C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d2b: additional applicable product code: nhl.
Event or Problem Description
It was reported that during a deep brain stimulation (dbs) implantation surgery, the lead could not be secured to the base using the burr hole cover's (bhc) retaining clip.Upon closer inspection, it appeared that the retaining clip was bent.The attending physician manually adjusted the clip slightly, enabling attachment to the base and used it as is.No additional adverse patient effects were reported.The bhc will not be returned to boston scientific for analysis as it remains implanted in the patient.
Additional Manufacturer Narrative
Correction to block: h2.Block d2b: additional applicable product code: nhl.
Event or Problem Description
It was reported that during a deep brain stimulation (dbs) implantation surgery, the lead could not be secured to the base using the burr hole cover's (bhc) retaining clip.Upon closer inspection, it appeared that the retaining clip was bent.The attending physician manually adjusted the clip slightly, enabling attachment to the base and used it as is.No additional adverse patient effects were reported.The bhc will not be returned to boston scientific for analysis as it remains implanted in the patient.
Additional Manufacturer Narrative
Block d2b: additional applicable product code: nhl.
Event or Problem Description
It was reported that during a deep brain stimulation (dbs) implantation surgery, the lead could not be secured to the base using the burr hole cover's (bhc) retaining clip.Upon closer inspection, it appeared that the retaining clip was bent.The attending physician manually adjusted the clip slightly, enabling attachment to the base and used it as is.No additional adverse patient effects were reported.The bhc will not be returned to boston scientific for analysis as it remains implanted in the patient.
Additional Manufacturer Narrative
This report is being submitted to correct the unique identifier (udi) # field (d4) in section d, suspect medical device.Correction to block: h2.Block d2b: additional applicable product code: nhl.
Event or Problem Description
It was reported that during a deep brain stimulation (dbs) implantation surgery, the lead could not be secured to the base using the burr hole cover's (bhc) retaining clip.Upon closer inspection, it appeared that the retaining clip was bent.The attending physician manually adjusted the clip slightly, enabling attachment to the base and used it as is.No additional adverse patient effects were reported.The bhc will not be returned to boston scientific for analysis as it remains implanted in the patient.

• 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: 24032927
• Report Number: 3006630150-2026-00258
• Device Sequence Number: 16072833
• Product Code: MHY
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802(17)270612(10)36688962
• 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: 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,Followup,Followup
• Report Date (Section B): 05/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DB-4600-C
• Device Catalogue Number: DB-4600-C
• Device Lot Number: 36688962
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 01/14/2026; 05/19/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/14/2026; 01/14/2026; 05/19/2026
• Date Device Manufactured: 06/12/2025
• 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
• Patient Age: 71 YR
• Patient Sex: Female