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

Model Number	SC-2158-50
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631); Charging Problem (2892)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: model number/catalog number: sc-2158-50, serial number: (b)(6), batch/lot number: 2000021408, model/catalog description: linear lead kit 50 cm, unique identifier (udi): (b)(4).Model number/catalog number: sc-1200, serial number: (b)(6), batch/lot number: (b)(6), model/catalog description: linear lead kit 50 cm, unique identifier (udi): (b)(4).Investigation results: the devices were not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed that the ipg and the leads met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: the device was not returned for analysis.Review of the images provided from the field showed that high impedances were identified.However, a labelling review found that the reported event is a known risk of implanting a pulse generator as part of a system to deliver spinal cord stimulation (scs).Therefore, this investigation is assigned a probable cause of known inherent risk of device.
Event or Problem Description
It was reported that the patient was experiencing loss of stimulation and high impedances were noted on both spinal cord stimulator (scs) leads.It was also stated that the patient's implantable pulse generator (ipg) was not holding a charge.The patient underwent a procedure wherein the leads and ipg were replaced and that the patient was doing well postoperatively.The explanted devices were discarded by the medical facility and will not be returned.

• Brand Name: LINEAR?
• 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: 24544007
• Report Number: 3006630150-2026-01371
• Device Sequence Number: 14874985
• Product Code: LGW
• UDI-Device Identifier: 08714729767695
• UDI-Public: (01)08714729767695(17)200417(10)5000773
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• 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): 03/09/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/17/2020
• Device Model Number: SC-2158-50
• Device Catalogue Number: SC-2158-50
• Device Lot Number: 5000773
• 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: 02/16/2026
• Initial Report FDA Received Date: 03/09/2026
• Date Device Manufactured: 04/18/2018
• 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: 55 YR
• Patient Sex: Female