MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; stimulator, electrical, implanted, for parkinsonian tremor

Model Number	NM-3138-55
Medical Device Problem Codes	High impedance (1291); Off-Label Use (1494); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Anxiety (2328); Depression (2361); Insufficient Information (4580)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient implanted with a deep brain stimulation (dbs) system for the treatment of obsessive compulsive disorder (ocd) underwent a lead extension revision procedure due to high impedances.The reported high impedances resulted in a loss of therapy effectiveness in the right hemisphere, with recurrence of the patient's ocd symptoms, including checking compulsions and pathological doubt, accompanied by comorbid depressive and anxiety symptoms.As a result, the patient underwent an unscheduled revision procedure and required hospitalization beyond the standard of care.Following the procedure, dbs therapy was reactivated, and the patient was discharged on the same day.The most recently available information indicated that the patient continues to experience symptoms of the underlying condition.However, this is not unexpected, as symptomatic improvement is generally observed within 4 to 8 weeks.From a physical standpoint, the patient is recovering well from surgery.
Additional Manufacturer Narrative
Block b3: approximation - symptoms have increased over the past several months.Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: model number/catalog number: nm-3138-55, serial number: (b)(6), batch/lot number: 7094830, model/catalog description: 55cm 8 contact extension, unique identifier (udi)#: (b)(4).

• 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; PR 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292-0920
• MDR Report Key: 50073429
• Report Number: 3006630150-2026-05388
• Device Sequence Number: 18696074
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: (01)08714729820765(17)240207(10)7095848
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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: 02/07/2024
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7095848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 07/29/2026
• Date Device Manufactured: 02/07/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown