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	Erosion (1750); Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: brand name: vercise? cartesia? upn: m365db2202450.Model: db-2202-45.Serial: null.Batch: null.Brand name: vercise genus? upn: m365db12160.Model: db-1216.Serial: null.Batch: null.Brand name: vercise? cartesia? upn: m365db2202450.Model: db-2202-45.Serial: null.Batch: null.Brand name: suretek? upn: m365db4600c0.Model: db-4600-c.Serial: null.Batch: null.
Event or Problem Description
It was reported that the patient developed an infection at both of the burr hole and bilateral lead sites, of the deep brain stimulation (dbs) system, on the skull.The infection developed due to the incision sites opening up because of the devices rubbing on the skin causing skin erosion.The patient symptoms included pain, swelling and redness at the site.The patient was prescribed medication, pending next course of action.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient developed an infection at both of the burr hole and bilateral lead sites, of the deep brain stimulation (dbs) system, on the skull.The infection developed due to the incision sites opening up because of the devices rubbing on the skin causing skin erosion.The patient symptoms included pain, swelling and redness at the site.The patient was prescribed medication.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: brand name: vercise? cartesia? upn: m365db2202450.Model: db-2202-45.Serial: null.Batch: null.Brand name: vercise genus? upn: m365db12160.Model: db-1216.Serial: null.Batch: null.Brand name: vercise? cartesia? upn: m365db2202450.Model: db-2202-45.Serial: null.Batch: null.Brand name: suretek? upn: m365db4600c0.Model: db-4600-c.Serial: null.Batch: null.With all the available information, boston scientific concludes that the cause of the patient experiencing an infection, being treated with antibiotics 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 was unable to be performed as the serial number is unknown.The devices were 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 risks of implanting the system.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 Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25586250
• Report Number: 3006630150-2026-04283
• Device Sequence Number: 14813824
• Product Code: PJS
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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 Model Number: DB-4600-C
• Device Catalogue Number: DB-4600-C
• 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: 06/08/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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 Sex: Unknown