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

Model Number	SC-3138-25
Medical Device Problem Codes	High impedance (1291); Defective Device (2588)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inadequate stimulation due to a damaged lead extension that resulted in a lead impedance.The patient underwent lead extension replacement and lead explant procedure.The patient was doing well postoperatively and the explanted devices were disposed by the facility.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred three days prior to the date the manufacturer became aware.Additional suspect medical device component involved in the event: product family: scs-linear leads upn: m365sc2366700 model: sc-2366-70 serial: (b)(6).Batch: 18389526 udi: (b)(4).Additional suspect medical device component involved in the event: product family: scs-linear leads upn: m365sc2366700 model: sc-2366-70 serial: (b)(6).Batch: 18066271 udi: (b)(4).Additional suspect medical device component involved in the event: product family: scs-paddle leads upn: m365sc8216700 model: sc-8216-70 serial: (b)(6).Batch: 17625091 udi: (b)(4).Additional suspect medical device component involved in the event: product family: scs-paddle leads upn: m365sc8216700 model: sc-8216-70 serial: (b)(6).Batch: 17514207 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22364409
• Report Number: 3006630150-2025-04977
• Device Sequence Number: 9482913
• Product Code: LGW
• UDI-Device Identifier: 08714729760542
• UDI-Public: (01)08714729760542(17)170607(10)18034016
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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: 06/07/2017
• Device Model Number: SC-3138-25
• Device Catalogue Number: SC-3138-25
• Device Lot Number: 18034016
• 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: 06/09/2025
• Initial Report FDA Received Date: 06/30/2025
• Date Device Manufactured: 06/08/2015
• 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: 39 YR
• Patient Sex: Female