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

Model Number	DB-2201-45DC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Scar Tissue (2060); Impaired Healing (2378)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Correction to field d2b: pro code (product code) correction to field h11: additional mfr narrative additional suspect medical device components involved in the event: model number/catalog number: db-2202-45 serial number: (b)(6) batch/lot number: 7132880 model/catalog description: dbs directional lead sterile kit 45cm unique identifier (udi) #(b)(4) model number/catalog number: db-3128-55b serial number: (b)(6) batch/lot number: 5002335 model/catalog description: 55cm 2x8 lead extension kit unique identifier (udi) # (b)(4).Model number/catalog number: db-4600-c serial number: n/a batch/lot number: 32211214 and 33133767 and 35357579 model/catalog description: suretek burr hole cover kit unique identifier (udi) # (b)(4) and(b)(4).And (b)(4).With all the available information, boston scientific concludes that the cause of the patient experiencing impaired healing and undergoing a procedure in which the leads were explanted was confirmed based on record review, the devices were not returned as they were discarded by the facility.A review of the manufacturing records associated with the device indicated that it was successfully processed according to requirements.The device history review, 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.The devices were discarded by the facility and not returned for analysis; therefore, a technical analysis could not be performed.A labeling review was performed on the device's instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.Based on all available information, engineers are able to confirm the root cause of the event.The devices were not returned as such physical analysis was not conducted, record review revealed no additional information related to the complaint.Therefore, this investigation is able to determine a probable root cause for the complaint, and the conclusion is known inherent risk of device.
Event or Problem Description
It was reported that the patient experienced erosion at the lead site on the lead site on the head of the deep brain stimulation (dbs) system and displayed scabbing and impaired healing.The patient underwent a procedure in which the devices were explanted.The devices will not be returned as they were disposed of by the facility.
Event or Problem Description
It was reported that the patient experienced erosion at the lead site on the lead site on the head of the deep brain stimulation (dbs) system and displayed scabbing and impaired healing.The patient underwent a procedure in which the devices were explanted.The devices will not be returned as they were disposed of by the facility.
Additional Manufacturer Narrative
Block d2b pro code (product code): nhl, pjs.Additional suspect medical device components involved in the event: model number/catalog number: db-2202-45 serial number: (b)(6).Batch/lot number: 7132880.Model/catalog description: dbs directional lead sterile kit 45cm unique identifier (udi) # (b)(4).Model number/catalog number: db-3128-55b serial number: (b)(6).Batch/lot number: 5002335 model/catalog description: 55cm 2x8 lead extension kit unique identifier (udi) # (b)(4).Model number/catalog number: db-4600-c serial number: n/a batch/lot number: 32211214 and 33133767 and 35357579 model/catalog description: suretek burr hole cover kit unique identifier (udi) # (b)(4).Investigation summary: device history record review: device technical analysis: labeling review: investigation conclusion:.

• Brand Name: NA
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24658896
• Report Number: 3006630150-2026-01698
• Device Sequence Number: 20113139
• Product Code: PJS
• UDI-Device Identifier: 08714729836544
• UDI-Public: (01)08714729836544(17)251210(10)7074829
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2026

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: 12/10/2025
• Device Model Number: DB-2201-45DC
• Device Catalogue Number: DB-2201-45DC
• Device Lot Number: 7074829
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 03/22/2026
• Initial Report FDA Received Date: 03/22/2026
• Supplement Report FDA Received Date: 03/22/2026
• Date Device Manufactured: 12/11/2023
• 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: 68 YR
• Patient Sex: Female