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	Wound Dehiscence (1154); Bacterial Infection (1735); Erosion (1750)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: db-4600-c, batch/lot number: 19412010, model/catalog description: suretek burr hole cover kit, gtin # (b)(4).Model number/catalog number: db-2201-45bc, serial number: (b)(6), batch/lot number: 16891177, model/catalog description: lead kit 45cm, unique identifier (udi) # (b)(4).Model number/catalog number: db-2201-45dc, serial number: (b)(6), batch/lot number: 17120572, model/catalog description: lead kit 45cm, unique identifier (udi) # (b)(4).Model number/catalog number: nm-3138-55, serial number: (b)(6), batch/lot number: 16795972 and 16757005, model/catalog description: 55cm 8 contact extension, unique identifier (udi) # (b)(4).Model number/catalog number: db-1110-c, serial number: (b)(6), batch/lot number: 16647083, model/catalog description: vercise ipg, unique identifier (udi) # (b)(4).
Event or Problem Description
It was reported that the patient experienced erosion, an open wound on the scalp, above the burr hole cover and underwent a full system explant.An infection was suspected, for which cultures were taken and confirmed bacterial infections of klebsiella oxytoca, raoultella ornithinolytica, stenotrophomonas maltophilia and haemophilus parainfluenzae; the patient was prescribed antibiotics and is doing well post operatively.No additional symptoms were reported related to the erosion or the infection.The devices were not returned to the manufacturer for analysis as they were all discarded by the facility.
Event or Problem Description
It was reported that the patient experienced erosion, an open wound on the scalp, above the burr hole cover and underwent a full system explant.An infection was suspected, for which cultures were taken and confirmed bacterial infections of klebsiella oxytoca, raoultella ornithinolytica, stenotrophomonas maltophilia and haemophilus parainfluenzae; the patient was prescribed antibiotics and is doing well post operatively.No additional symptoms were reported related to the erosion or the infection.The devices were not returned to the manufacturer for analysis as they were all discarded by the facility.
Additional Manufacturer Narrative
Block d2b pro code (product code): nhl.Additional suspect medical device components involved in the event: model number/catalog number: db-4600-c, serial number: (b)(6), batch/lot number: 19412010, model/catalog description: suretek burr hole cover kit gtin # (b)(6).Model number/catalog number: db-2201-45bc, serial number: (b)(6), batch/lot number: 16891177, model/catalog description: lead kit 45cm, unique identifier (udi) # (b)(4).Model number/catalog number: db-2201-45dc, serial number: (b)(6), batch/lot number: 17120572, model/catalog description: lead kit 45cm, unique identifier (udi) # (b)(4) model number/catalog number: nm-3138-55, serial number: (b)(6), batch/lot number: 16795972 and 16757005, model/catalog description: 55cm 8 contact extension, unique identifier (udi) # (b)(4).Model number/catalog number: db-1110-c, serial number: (b)(6), batch/lot number: 16647083, model/catalog description: vercise ipg, unique identifier (udi) # (b)(4).With all the available information, boston scientific concludes that the cause of the patient experiencing erosion, infection and undergoing a system explant could not be confirmed.The devices were not returned therefore device analysis could not be done.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.The device was discarded by the facility and not returned for analysis; therefore, a technical analysis could not be performed.A labeling review was performed on the devices' instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.It states infection, implant site complications such as pain, poor healing, redness, warmth, swelling or wound reopening are a risk of implanting the system.A sterilization record review (srr) was performed, and the review identified no sterilization related findings that could be reasonably associated with the reported event.Based on all available information, engineers are not able to confirm the root cause of the event.The devices were not returned, as such, physical analysis could not be conducted in our laboratory.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable root cause for the complaint and the conclusion is cause not established.

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25803849
• Report Number: 3006630150-2026-04887
• Device Sequence Number: 8987165
• Product Code: MHY
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802(17)170811(10)2000014101
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 09/22/2026

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: Lay User/Patient
• Device Expiration Date: 08/11/2017
• Device Model Number: DB-4600-C
• Device Catalogue Number: DB-4600-C
• Device Lot Number: 2000014101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 12/16/2015
• 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: 70 YR
• Patient Sex: Female