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

Model Number	DB-3128-55B
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
With all the available information, boston scientific concludes that the cause of the patient experiencing inadequate stimulation and undergoing a lead extension replacement procedure could not be confirmed.The device was not returned therefore device analysis could not be performed.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 device was 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.It states loss of therapy effectiveness, return or worsening of tremor, and lead or extension fracture as potential risks associated with the use of the deep brain stimulation (dbs) device, including loss of therapeutic effect or diminished stimulation, worsening of symptoms, and device components may break or fracture.Based on all available information, engineers are not able to confirm the root cause of the event.The device was 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.
Event or Problem Description
It was reported that the patient underwent a lead extension replacement due to inadequate stimulation causing a decrease in therapy and the patient's preexisting symptoms of tremor to return on the right and left side of their body.During the procedure it was noted that there was no visible damage of the lead extension, however during the revision procedure lead extension was fractured as the physician was explanting the device.The patient is recovering from the procedure, however, her the symptoms of tremor are still not controlled, and will be undergoing additional programming.

• 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: 25224976
• Report Number: 3006630150-2026-03300
• Device Sequence Number: 21284772
• Product Code: PJS
• UDI-Device Identifier: 00191506023577
• UDI-Public: (01)00191506023577(17)250618(10)5001392
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: 06/18/2025
• Device Model Number: DB-3128-55B
• Device Catalogue Number: DB-3128-55B
• Device Lot Number: 5001392
• 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: 04/21/2026
• Initial Report FDA Received Date: 05/19/2026
• Date Device Manufactured: 06/19/2023
• 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: 55 YR
• Patient Sex: Female