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

Model Number	DB-3128-55B
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Migration (4003)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient with a deep brain stimulation (dbs) system experienced inadequate tremor control.Functional testing revealed high impedances on multiple left and right contacts.The physician attributed the issue to repeated manipulation by the patient of the implantable pulse generator (ipg), which likely twisted the extension and caused a fracture near the header.The patient underwent revision surgery to remove and replace the lead extension.Analysis was not performed, as the extension sustained additional damage during explant and was discarded by the physician.The procedure was completed successfully and issues were resolved.
Additional Manufacturer Narrative
Section/block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-ipg-r-mri.Upn: m365db12160.Model: db-1216.Serial: (b)(6).Batch: 753126.Udi: (b)(4).
Additional Manufacturer Narrative
Section b5 describe event or problem was updated.Additional suspect medical device components involved in the event: product family: dbs-ipg-r-mri.Upn: m365db12160.Model: db-1216.Serial: (b)(6).Batch: 753126.Udi: ((b)(4).
Event or Problem Description
It was reported that a patient with a deep brain stimulation (dbs) system experienced inadequate tremor control.Functional testing revealed high impedances on multiple left and right contacts.The physician attributed the issue to repeated manipulation by the patient of the implantable pulse generator (ipg), which likely twisted the extension and caused a fracture near the header.The patient underwent revision surgery to remove and replace the lead extension.Analysis was not performed, as the extension sustained additional damage during explant and was discarded by the physician.The procedure was completed successfully and issues were resolved.Additional information received confirmed all fractured lead extension pieces were successfully removed during procedure and ipg was repositioned to address migration and remains implanted.The patient did well post-operatively.

• 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: 23931261
• Report Number: 2124215-2025-93868
• Device Sequence Number: 18503675
• Product Code: PJS
• UDI-Device Identifier: 00191506023577
• UDI-Public: (01)00191506023577(17)260214(10)5002355
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/06/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/14/2026
• Device Model Number: DB-3128-55B
• Device Catalogue Number: DB-3128-55B
• Device Lot Number: 5002355
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/06/2026
• Date Device Manufactured: 02/15/2024
• 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: 79 YR
• Patient Sex: Female
• Patient Race: White