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

Model Number	DB-3128-95
Medical Device Problem Codes	High impedance (1291); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: date of event - approximately began in the first week of october 2025 - exact date unknown.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a loss of therapy after an accident playing football.The patient experienced dystonic movements in the arm and in the gait movement on the right side of the body.X-ray imaging was performed and confirmed the presence of high impedances.The patient underwent a revision procedure where the lead extension was replaced, and the high impedances resolved.The patient was doing well postoperatively.
Additional Manufacturer Narrative
Device technical analysis: visual inspection of the returned lead extension revealed that the lead extension tail cables were broken from the lead extension connector.Additionally, the lead extension tails were separated from the y-boot approximately 12 cm from the proximal end.The cables are exposed at the damaged sections of the lead extension.It appears that excessive mechanical force was applied to the lead extension tails and connector during the patients accident, resulting in cable fractures, high impedances, and the reported loss of therapy.Device history record review: a review of the manufacturing records associated with this device indicated that it was 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.The labeling appropriately states that failure or malfunction of any device component, including, but not limited to, lead or extension breakage, hardware malfunction, loose connections, electrical shorts, or open circuits may result in a loss of adequate stimulation.Such loss of therapeutic effect can lead to the recurrence of motor symptoms, including postural instability, gait disturbances, tremor, dystonia, dyskinesias, and falls.These events may necessitate device explantation or reimplantation and are recognized risks associated with deep brain stimulation (dbs) therapy, as documented in the instructions for use (ifu).Investigation conclusion based on the available evidence, the reported occurrence of high impedances and loss of stimulation was confirmed.Visual inspection revealed that the lead extension exhibited significant external mechanical damage, including fractures of the lead extension tail cables at the connector and separation of the tails from the y boot.The damage pattern is consistent with excessive mechanical force during the patients football accident, resulting in cable fractures and subsequently causing the high impedances and loss of stimulation.The dhr confirmed the device met specifications and no manufacturing issues that could have caused the event were identified.Although the reported event is a known risk with the use of dbs, it was reported that the loss of therapy occurred after the patient had an accident playing football, therefore the most likely root cause is an unintended use error caused or contributed to this event.A risk review of the dbs 2x8 extension 95cm sterile kit was completed and confirmed that the event of loss/no stimulation 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.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a loss of therapy after an accident playing football.The patient experienced dystonic movements in the arm and in the gait movement on the right side of the body.X-ray imaging was performed and confirmed the presence of high impedances.The patient underwent a revision procedure where the lead extension was replaced, and the high impedances resolved.The patient was doing well postoperatively.

• 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: 23611409
• Report Number: 3006630150-2025-10611
• Device Sequence Number: 18456157
• Product Code: NHL
• UDI-Device Identifier: 08714729966388
• UDI-Public: (01)08714729966388(17)221029(10)5000372
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 02/13/2026

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: 10/29/2022
• Device Model Number: DB-3128-95
• Device Catalogue Number: DB-3128-95
• Device Lot Number: 5000372
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• 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