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

Model Number	DB-4605-C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the deep brain stimulation (dbs) implant procedure, a portion of the locking cap on the burr hole cover broke off when the physician attempted to close the door.The burr hole cover was replaced, allowing the procedure to be completed successfully and the patient was doing well postoperatively.It was later confirmed that the lead stylet had not been removed before the slider was locked in place.
Additional Manufacturer Narrative
This device was received and is currently undergoing technical analysis.The investigation is not yet complete.A supplemental report will be submitted once the results are available.A review of the manufacturing records associated with this device indicated that it was successfully processed according to requirements.The dhr did not identify any manufacturing process-related non-conformances, scrap, or rework performed during production that could have caused or contributed to this event.The dhr review ensures each device meets required specifications and associated testing prior to release for distribution/sale.
Event or Problem Description
It was reported that during the deep brain stimulation (dbs) implant procedure, a portion of the locking cap on the burr hole cover broke off when the physician attempted to close the door.The burr hole cover was replaced, allowing the procedure to be completed successfully and the patient was doing well postoperatively.It was later confirmed that the lead stylet had not been removed before the slider was locked in place.

• 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: 24405063
• Report Number: 3006630150-2026-01032
• Device Sequence Number: 8168379
• Product Code: NHL
• UDI-Device Identifier: 08714729820819
• UDI-Public: (01)08714729820819(17)270716(10)36916163
• 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
• 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
• Report Date (Section B): 04/02/2026

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: Health Professional
• Device Model Number: DB-4605-C
• Device Catalogue Number: DB-4605-C
• Device Lot Number: 36916163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/05/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/02/2026
• Date Device Manufactured: 07/16/2025
• 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: 47 YR
• Patient Sex: Male