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

Model Number	DB-3128-55B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erosion (1750)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximation: according to the patient, erosion was noted approximately "a few weeks ago," relative to the event notification date.Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: 7098535.Udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a full system explant procedure due to erosion at the lead extension - lead connection site.Erosion was suspected to have occurred due to prior radiation.The patient had a biopsy that was removed in office by another provider, who did take into account the already fragile skin given past radiation.The patient experienced skin erosion and hardware exposure.The patient was placed on antibiotics, and cultures were taken; however, results were not disclosed.Postoperatively, the patient is stable.The explanted devices will not be returned to boston scientific as they were retained by the facility.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a full system explant procedure due to erosion at the lead extension - lead connection site.Erosion was suspected to have occurred due to prior radiation.The patient had a biopsy that was removed in office by another provider, who did take into account the already fragile skin given past radiation.The patient experienced skin erosion and hardware exposure.The patient was placed on antibiotics, and cultures were taken; however, results were not disclosed.Postoperatively, the patient is stable.The explanted devices will not be returned to boston scientific as they were retained by the facility.
Additional Manufacturer Narrative
The devices were retained by the facility and not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A labeling review was performed on the device's instructions for use (ifu).There is no evidence that the device was used in a manner inconsistent with the labelled indications.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• 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: 24117325
• Report Number: 2124215-2026-03560
• Device Sequence Number: 21255170
• Product Code: PJS
• UDI-Device Identifier: 00191506023577
• UDI-Public: (01)00191506023577(17)250828(10)5001860
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2026
• 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): 03/27/2026

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: 08/28/2025
• Device Model Number: DB-3128-55B
• Device Catalogue Number: DB-3128-55B
• Device Lot Number: 5001860
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 08/29/2023
• 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: 78 YR
• Patient Sex: Male