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

Model Number	DB-3128-95
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced high impedances caused by a fractured lead extension.The patient underwent a revision procedure where the lead extension was replaced.After replacing the lead extension there were still high impedance measurements present.The implantable pulse generator (ipg) was replaced.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-ipg-r-mri, upn: m365db12160, model: db-1216, serial: (b)(6), batch: 542878, udi: (b)(4).Initial reporters phone number is (b)(6) reported here as phone number exceeded character limit for designated field.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced high impedances caused by a fractured lead extension.The patient underwent a revision procedure where the lead extension was replaced.After replacing the lead extension there were still high impedance measurements present.The implantable pulse generator (ipg) was replaced.Additional information was received indicating the correct event date of the high impedances.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced high impedances caused by a fractured lead extension.The patient underwent a revision procedure where the lead extension was replaced.After replacing the lead extension there were still high impedance measurements present.The implantable pulse generator (ipg) was replaced.Additional information was received indicating the correct event date of the high impedances.
Additional Manufacturer Narrative
Device technical analysis: visual inspection of the returned lead extension revealed that the lead extension tail was completely separated from the lead extension connector.It appears that excessive mechanical force was exerted from the lead extension tail, resulting in its separation from the lead extension connector and causing the reported high impedances.Additionally, the lead extension was cleanly cut approximately 12 cm from the proximal end.The clean-cut damage is a result of a typical explant procedure, and it is not considered a failure.The returned ipg passed visual inspection, however high impedances measurements were observed on a known good load board and remote control.X-ray inspection revealed fractured feedthrough ground and bluetooth wires.The cause of the fractures was not determined as this device was implanted subcutaneously which is in accordance with the instructions for use (ifu).Device history record review: a review of the manufacturing records associated with these devices indicated that they were successfully processed according to requirements.The 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.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 or extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits may lead to a loss of adequate stimulation and 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 the available evidence, the reported occurrence of high impedances was confirmed.The issue was attributed to excessive mechanical force applied to the lead extension tail, which caused it to detach from the lead extension connector.This separation led to component failure and the observed high impedances.X-ray examination of the ipg identified fractures in the feedthrough ground and bluetooth wires.However, the root cause of these fractures could not be determined, as the observational findings confirmed that the ipg was implanted subcutaneously in accordance with the instructions for use (ifu).

• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• 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: 22396230
• Report Number: 3006630150-2025-05111
• Device Sequence Number: 4901725
• Product Code: NHL
• UDI-Device Identifier: 08714729966388
• UDI-Public: (01)08714729966388(17)230518(10)5000560
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/11/2025

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: 05/18/2023
• Device Model Number: DB-3128-95
• Device Catalogue Number: DB-3128-95
• Device Lot Number: 5000560
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 11/14/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/01/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• 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