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

Model Number	DB-3128-55B
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fall (1848); Insufficient Information (4580)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a fall and a loss of their therapy.It was not known if the fall was related to the dbs device.High impedance readings were discovered on the left-sided lead.Therefore, the patient underwent a revision procedure during which it was discovered that the lead extension was physically fractured at the implantable pulse generator (ipg) port site.Thus, the lead extension was explanted and replaced.Impedance readings were resolved postoperatively and the patient is receiving therapy again.
Additional Manufacturer Narrative
Block b3: exact date unknown, based off bsc aware date block d2b: additional pro code selection that applies to the indication of this device nhl.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a fall and a loss of their therapy.It was not known if the fall was related to the dbs device.High impedance readings were discovered on the left-sided lead.Therefore, the patient underwent a revision procedure during which it was discovered that the lead extension was physically fractured at the implantable pulse generator (ipg) port site.Thus, the lead extension was explanted and replaced.Impedance readings were resolved postoperatively and the patient is receiving therapy again.
Additional Manufacturer Narrative
Device analysis performed on the returned lead extension revealed that multiple cables were completely broken at the bent/kinked section close to the proximal end near the vent port.This type of damage typically occurs when excessive tensile force is exerted onto the lead extension body and connector section.The broken cables were still contained inside the connector.Additionally, the lead extension was cleanly cut close to the lead extension connector which is typically a result of the explant procedure and is not considered a failure.It was confirmed the device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A labeling review that was performed confirmed that lead extension breakage, loose connections, hardware anomalies, electrical shorts, open circuits and motor problems such as paresis, weakness, incoordination, restlessness, muscle spasms, postural/gait disorders, tremor, dystonia or dyskinesias are known risks associated with use of dbs, as documented in the instructions for use (ifu).A risk review was completed and confirmed that the event of impedance high was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to component failure.Block b3: exact date unknown, based off bsc aware date.Block d2b: additional pro code selection that applies to the indication of this device .

• 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: 23634078
• Report Number: 2124215-2025-86056
• Device Sequence Number: 21411198
• Product Code: MHY
• 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: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 07/04/2025
• Device Model Number: DB-3128-55B
• Device Catalogue Number: DB-3128-55B
• Device Lot Number: 5001526
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• 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: 58 YR
• Patient Sex: Female