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

Model Number	NM-3138-55
Medical Device Problem Codes	High impedance (1291); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	06/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a slight reduction in treatment efficacy and high impedances were discovered over a widespread area.There was no issue observed with the leads; it was determined that the lead extensions were the cause of the impedance readings.Therefore, the patient underwent a revision procedure during which the lead extensions were replaced.Following replacement, the impedances returned to within a normal range and the patient was doing well postoperatively.
Additional Manufacturer Narrative
Block d2b: additional pro code selection that applies to the indication of this device additional suspect medical device component involved in the event: product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a slight reduction in treatment efficacy and high impedances were discovered over a widespread area.There was no issue observed with the leads; it was determined that the lead extensions were the cause of the impedance readings.Therefore, the patient underwent a revision procedure during which the lead extensions were replaced.Following replacement, the impedances returned to within a normal range and the patient was doing well postoperatively.
Additional Manufacturer Narrative
Device analysis was performed on the returned lead extensions sc-3138-55 serial numbers (b)(6).Lead extension serial number (b)(6) passed visual and functional testing with no anomalies.Visual inspection of lead extension serial number (b)(6) revealed that multiple cables were fractured after the weld in the distal connector stack.The broken cables were still contained inside the connector.This type of damage typically occurs when excessive tensile force is exerted onto the lead extension body and connector section.This damage likely resulted in the reported reduction of treatment efficacy and high impedance readings.A product labeling review that was conducted determined that lead breakage, loose connections and electrical issues can result in reduction in pain relief and is a known risk of implanting a pulse generator as part of a system to deliver spinal cord stimulation, as documented in the instructions for use (ifu).Block d2b: additional pro code selection that applies to the indication of this device .Additional suspect medical device component involved in the event: product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).

• 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: 23129291
• Report Number: 3006630150-2025-07931
• Device Sequence Number: 9287254
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: (01)08714729820765(17)230311(10)7085322
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: 03/11/2023
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7085322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• 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