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

Model Number	DB-3216-55
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Migration (4003)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inadequate stimulation.The patient had a history of falls attributed to orthostatic hypotension associated with parkinson's disease.The treating physician suspected that a fall may have damaged the deep brain stimulation (dbs) system.As part of the investigation, a surgical exploration was performed at the implantable pulse generator (ipg) pocket.Upon examination, it was observed that the suture loops securing the ipg had broken, the ipg had rotated within the pocket, and the extensions were visibly fractured and twisted.The physician also explored the intermediate incision site and removed the damaged extensions.New extensions were tunneled and connected to the existing leads and ipg.Following reconnection, impedance measurements were within normal limits, and the system was confirmed to be fully operational with no damage identified in the leads or ipg.Postoperatively, the patient was returned to the pre-existing stimulation settings and discharged following the outpatient procedure.The explanted devices will not be returned for analysis, as they were disposed of.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: db-3216-55, serial number: (b)(6), batch/lot number: 5004238, model/catalog description: argyle extension 55cm sterile kit, unique identifier (udi)#: (b)(4), model number/catalog number: db-1432, serial number: (b)(6), batch/lot number: 242179, model/catalog description: vercise genus p32 ipg kit, unique identifier (udi)#: (b)(4).

• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50168278
• Report Number: 3006630150-2026-05645
• Device Sequence Number: 17462561
• Product Code: NHL
• UDI-Device Identifier: 08714729966395
• UDI-Public: (01)08714729966395(17)271010(10)5004247
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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 Model Number: DB-3216-55
• Device Catalogue Number: DB-3216-55
• Device Lot Number: 5004247
• 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: 07/17/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 10/10/2025
• 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: 72 YR
• Patient Sex: Male