MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-3138-35
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: date of event approximate.Additional suspect medical device component involved in the event: brand name: na, upn: m365sc3138350, model: sc-3138-35, serial: (b)(6), batch: 7077454, udi: (b)(4).Brand name: na, upn: m365sc3138350, model: sc-3138-35, serial: (b)(6), batch: 7077427, udi: (b)(4).Brand name: na, upn: m365sc3138350, model: sc-3138-35, serial: (b)(6), batch: 7077648, udi: (b)(4).
Event or Problem Description
It was noted that the patient experienced an increase in migraines.The physician does not feel the migraines are device or procedure related.The patients system was optimized however the issue persisted.The patient was hospitalized and underwent a revision procedure in which it was determined that one of the patients lead extensions displayed high impedances.The physician decided to replace the lead extension and recheck impedances and subsequently, no impedances were detected.The explanted lead extension will not be returned as it was discarded at the medical facility.The patient was doing fine postoperatively and has been discharged from the hospital.

• 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; 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: 22789922
• Report Number: 3006630150-2025-06416
• Device Sequence Number: 9823392
• Product Code: LGW
• UDI-Device Identifier: 08714729760559
• UDI-Public: (01)08714729760559(17)240604(10)7077913
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 08/12/2025

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: 06/04/2024
• Device Model Number: SC-3138-35
• Device Catalogue Number: SC-3138-35
• Device Lot Number: 7077913
• 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: 07/21/2025
• Initial Report FDA Received Date: 08/12/2025
• Date Device Manufactured: 06/05/2022
• 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: Required Intervention
• Patient Sex: Male