MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; stimulator, spinal-cord, totally implanted for pain relief

Model Number	SC-4254
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an implant procedure during which the physician assessed the tunneling tool was too sharp and not rigid enough to bend properly.A non-boston scientific (bsc) tunneling tool was used to complete the procedure.Post-operative computerized tomography (ct) imaging that was taken confirmed the left lead had migrated which the physician attributed to the bsc tunneling tool difficulty.Therefore, the patient underwent a revision procedure the following day to replace the left lead.The tunneling tool and explanted lead will not be returned as they were discarded by the medical facility.
Additional Manufacturer Narrative
Block d2b: additional pro code selection that applies to the indication of this device additional product(s) in device system: model number/catalog number: db-2202-30, serial number: (b)(6), batch/lot number: 7088896, model/catalog description: dbs directional lead sterile kit 30 cm, unique identifier (udi) #: (b)(4).

• Brand Name: NA
• Common Device Name: stimulator, spinal-cord, totally implanted for pain relief
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; 4100 hamline avenue north; saint paul MN 55112 -579
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50776037
• Report Number: 3006630150-2026-06733
• Device Sequence Number: 18781936
• Product Code: MHY
• UDI-Device Identifier: 08714729762751
• UDI-Public: (01)08714729762751(17)271209(10)38032569
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: Health Professional
• Device Model Number: SC-4254
• Device Catalogue Number: SC-4254
• Device Lot Number: 38032569
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 12/09/2025
• 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 Sex: Unknown