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

Model Number	DB-3128-55B
Medical Device Problem Codes	High impedance (1291); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: additional pro codes in block d2b nhl, pjs.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-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7099667, udi: (b)(4).Product family: dbs-linear leads, upn: m365db2202450.Model: db-2202-45, serial: (b)(6), batch: 7099242, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced several accidental non-device related falls and noted a high impedance on both leads levels three and four via functional testing.The patient underwent a procedure wherein testing confirmed the lead extension was the device with high impedances as a result was replaced with another of the same model.It was noted that the right brain lead had a crimp at the tail end where it connects with the extension, however it is unknown which serial number lead had the crimp therefore are reporting on both leads.Additional testing revealed a high impedance in contact l1, attempts to clear the high impedance was performed however were unsuccessful as a result the physician opted to complete the procedure.The leads and lead extension remain implanted, and the system was successfully programmed around the high impedance contact.The patient did well post-operatively and is receiving adequate therapy.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced several accidental non device related falls and noted a high impedance on both leads levels three and four via functional testing.The patient underwent a procedure wherein testing confirmed the lead extension was the device with high impedances as a result was replaced with another of the same model.It was noted that the right brain lead had a crimp at the tail end where it connects with the extension, however it is unknown which serial number lead had the crimp therefore are reporting on both leads.Additional testing revealed a high impedance in contact l1, attempts to clear the high impedance was performed however were unsuccessful as a result the physician opted to complete the procedure.The leads and lead extension remain implanted, and the system was successfully programmed around the high impedance contact.The patient did well post-operatively and is receiving adequate therapy.
Additional Manufacturer Narrative
The returned explanted dbs lead extension was analyzed, visual inspection revealed that was cleanly cut into two pieces away from proximal end.X-ray inspection revealed four of the cables were fractured after the weld in the distal connector stack however remained contained inside connector, this type of damage occurs when excessive tensile force is exerted onto the lead extension body and connector sections.A labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, labeling states failure or malfunction of any of the device components or the battery, including but not limited to the lead extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, whether or not this requires surgical intervention, including motor problems and falls or injuries resulting from these problems are known risks with the use of dbs.With all the available information, boston scientific concludes that the probable cause is traced to component failure.

• 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: 21821431
• Report Number: 2124215-2025-22871
• Device Sequence Number: 9253725
• Product Code: MHY
• UDI-Device Identifier: 00191506023577
• UDI-Public: 00191506023577
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 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): 06/09/2025

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: 10/19/2024
• Device Model Number: DB-3128-55B
• Device Catalogue Number: DB-3128-55B
• Device Lot Number: 5000234
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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: 35 YR
• Patient Sex: Male