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

Model Number	NM-3138-55
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro code selection that applies to the indication of this device product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7114740, udi: (b)(4).Product family: dbs-linear leads, upn: m365db2202450, model:db-2202-45, serial: (b)(6), batch: 7105452, udi:(b)(4).
Event or Problem Description
During a deep brain stimulation (dbs) procedure, high impedances were identified on both of the patients leads.Multiple troubleshooting steps were attempted; however, the issue persisted.The physician determined that the elevated impedances were attributable to the lead extensions.The physician made an incision at the extension header to check the leads and noticed one of the leads was bent.Both lead extensions were subsequently explanted and replaced.The patient recovered well and is reported to be in good condition postoperatively.
Additional Manufacturer Narrative
The devices nm-3138-55, serial number (b)(6) and the device db-2202-45, serial number (b)(6) were not returned to boston scientific for analysis and the complaint as reported was not able to be confirmed, however a review of the device history record (dhr) confirmed that the device met specification prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of: cause not established.Additional pro code selection that applies to the indication of this device product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7114740.Udi: (b)(4).Product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: 7105452.Udi: (b)(4).
Event or Problem Description
It was reported that during a deep brain stimulation (dbs) procedure, high impedances were identified on both of the patients leads.Multiple troubleshooting steps were attempted; however, the issue persisted.The physician determined that the elevated impedances were attributable to the lead extensions.The physician made an incision at the extension header to check the leads and noticed one of the leads was bent.Both lead extensions were subsequently explanted and replaced.The patient recovered well and is reported to be in good condition postoperatively.

• 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; EI 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24454136
• Report Number: 3006630150-2026-01117
• Device Sequence Number: 21369378
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: (01)08714729820765(17)250401(10)7113436
• 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: 2023
• 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): 04/20/2026

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: 04/01/2025
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7113436
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 04/02/2023
• 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: 79 YR
• Patient Sex: Male