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	Insufficient Information (4580)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a lack of efficacy with the therapy.It was discovered through examination of the device hardware that there were high impedance measurements on the lead extensions.The patient underwent a revision procedure where the lead extensions were replaced.
Additional Manufacturer Narrative
Additional suspect medical device components 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 lack of efficacy with the therapy.It was discovered through examination of the device hardware that there were high impedance measurements on the lead extensions.The patient underwent a revision procedure where the lead extensions were replaced.Additional information was received indicating that the patient was doing well postoperatively.The initial implant date and explant date of the lead extensions was also provided.
Additional Manufacturer Narrative
D2b: pro code (product code): pjs, mhy; reported here as the pro code exceeded the character limit for designated field.
Additional Manufacturer Narrative
Device technical analysis: visual and x-ray inspection of the returned lead extension nm-3138-55 serial number (b)(6) was performed and revealed that one of the cables was fractured after the weld in the distal connector stack.This type of damage typically occurs when excessive tensile force is exerted onto the lead extension body and connector section of the lead extension.The broken cable is still contained inside the connector.Visual and x-ray inspection of the return lead extension nm-3138-55 serial number (b)(6) was performed and revealed that all of the cables were fractured after the weld in the distal connector stack.This type of damage typically occurs when excessive tensile force is exerted onto the lead extension body and connector section of the lead extension.The broken cables are still contained inside the connector.Labeling review: a labelling review was performed, and it did not reveal any anomalies as it states failure or malfunction of any of the device components, including but not limited to lead extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches may require explant or reimplantation and are known risks associated with the use of dbs therapy as documented in the instructions for use (ifu).Investigation conclusion: based on all available information, the reported event of high impedances was confirmed.X-ray inspection of the lead extensions revealed fractured cables after the weld in the distal connector stack.This type of damage typically occurs when excessive tensile force is exerted onto the lead body and connector section of the lead extension.The broken cables are still contained inside the connector.Therefore, the most probable cause of the event can be traced to component failure.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a lack of efficacy with the therapy.It was discovered through examination of the device hardware that there were high impedance measurements on the lead extensions.The patient underwent a revision procedure where the lead extensions were replaced.Additional information was received indicating that the patient was doing well postoperatively.The initial implant date and explant date of the lead extensions was also provided.

• 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: 22873546
• Report Number: 3006630150-2025-06763
• Device Sequence Number: 5803379
• Product Code: NHL
• UDI-Device Identifier: 08714729820765
• UDI-Public: (01)08714729820765(17)250708(10)7116457
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2025

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: 07/08/2025
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7116457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 11/17/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2023
• 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 Sex: Unknown