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); Nonstandard Device (1420); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Fall (1848); Shaking/Tremors (2515)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an exploratory revision due to high impedances on the leads and recurrence of the patient's tremor.The physician began at the implantable pulse generator (ipg) and observed that the connected extension lead was frayed.The possibility that the patient may have manipulated the ipg and had recently experienced falls could be related to the frayed extension; however, this was not confirmed, and it remains unknown whether the patient's falls were device or stimulation related.The extension was replaced and connected, impedances were resolved, and the patient's symptoms subsided.The patient's postoperative status is good.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b: additional applicable product code: nhl.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7121753, udi: (b)(4).Product family: dbs-linear leads upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7121757, udi: (b)(4).Product family: dbs-ipg-r-mri: upn: m365db12160, model: db-1216, serial: (b)(6), batch: 761324, udi: (b)(4).
Additional Manufacturer Narrative
With all the available information, boston scientific concluded through laboratory analysis that inadequate stimulation and high impedances were caused by multiple cables being completely broken at the bent/kinked section close to the proximal end, near the vent port.Damage to the proximal tails resulted in the reported complaint.Additionally, the lead extension was cleanly cut close the lead extension connector.This type of clean-cut damage is consistent with a standard explant procedure and is not considered a device failure.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A labeling review did not reveal any anomalies and states that failure or malfunction of any of the device components or the battery, including but not limited to lead or extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, whether or not this requires explant and/or reimplantation and motor problems such as paresis, weakness, incoordination, restlessness, muscle spasms, postural and gait disorders, tremor, dystonia, or dyskinesias, and falls or injuries resulting from these problems are known risks with the use of deep brain stimulation (dbs).Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced due to component failure.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an exploratory revision due to high impedances on the leads and recurrence of the patient's tremor.The physician began at the implantable pulse generator (ipg) and observed that the connected extension lead was frayed.The possibility that the patient may have manipulated the ipg and had recently experienced falls could be related to the frayed extension; however, this was not confirmed, and it remains unknown whether the patient's falls were device or stimulation related.The extension was replaced and connected, impedances were resolved, and the patient's symptoms subsided.The patient's postoperative status is good.

• 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: 24031898
• Report Number: 2124215-2026-01733
• Device Sequence Number: 9140247
• Product Code: MHY
• UDI-Device Identifier: 00191506023577
• UDI-Public: (01)00191506023577(17)260627(10)5003170
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 06/26/2026
• Device Model Number: DB-3128-55B
• Device Catalogue Number: DB-3128-55B
• Device Lot Number: 5003170
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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: 63 YR
• Patient Sex: Male