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

Model Number	DB-4600-C
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	Pneumocephalus (4587)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the deep brain stimulation (dbs) lead implant procedure the retaining clip on the burr hole cover was not secure inside the base ring during closing, and the lead migrated.The patient was brought back to the operating room on the same day where the physician attempted to advance the lead but it would not follow the same fresh track.The site was sutured and closed.The patient experienced pneumocephalus post operatively.The patient later underwent a revision procedure where the burr hole cover and lead were replaced.The patient was doing well postoperatively.The explanted devices were retained by the hospital and were not returned.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7143314, udi: (b)(4).
Event or Problem Description
It was reported that during the deep brain stimulation (dbs) lead implant procedure the retaining clip on the burr hole cover was not secure inside the base ring during closing, and the lead migrated.The patient was brought back to the operating room on the same day where the physician attempted to advance the lead but it would not follow the same fresh track.The site was sutured and closed.The patient experienced pneumocephalus post operatively.The patient later underwent a revision procedure where the burr hole cover and lead were replaced.The patient was doing well postoperatively.The explanted devices were retained by the hospital and were not returned.
Additional Manufacturer Narrative
Correction to field h6 device codes: added code of migration for the additional suspect device lead that is related to this event.Physical analysis could not be completed in our laboratory, as the devices were retained by the hospital and were not returned.A review of the manufacturing records associated with these devices indicated that they were 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.A labelling review was performed, and it did not reveal any anomalies as it states, implanted device components (stimulator, lead, or lead extension) may move from original implanted location or wear through the skin, which may lead to the need for additional surgery and is a known risk with the use of deep brain stimulation (dbs).The devices were not returned as they were retained by the hospital.As such, physical analysis has not been conducted in our laboratory, therefore the reported allegation of the burr hole cover was not secure inside the base ring during closing could not be confirmed.The root cause of the reported event could not be established.A review of the devices manufacturing documentation confirmed that the devices passed all required specifications and testing prior to being released for distribution or sale.Additionally, a labeling review was conducted.This review determined that migration is a known risk associated with the use of deep brain stimulation (dbs) as documented in the instructions for use (ifu).A risk review of the suretek burr hole cover kit was completed and confirmed that the event of unable to lock bhc door was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A risk review of the dbs directional lead sterile kit 45cm was completed and confirmed that the event of migration was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.

• 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: 23600884
• Report Number: 3006630150-2025-10581
• Device Sequence Number: 9841115
• Product Code: NHL
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802(17)270807(10)37016880
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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
• Report Date (Section B): 04/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DB-4600-C
• Device Catalogue Number: DB-4600-C
• Device Lot Number: 37016880
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 08/07/2025
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female