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

Model Number	SC-2218-50E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Undesired Nerve Stimulation (1980)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing chest pain when the stimulation was on.The patient underwent an early lead pull procedure.Patient is doing fine postoperatively.The explanted device was not returned.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads.Upn: m365sc221850e0.Model: sc-2218-50.Serial: (b)(6).Batch: 17480071.Udi: (b)(4).
Event or Problem Description
It was reported that the patient was experiencing chest pain when the stimulation was on.The patient underwent an early lead pull procedure.Patient is doing fine postoperatively.The explanted device was not returned.
Additional Manufacturer Narrative
Investigation result: the device was not returned to boston scientific for analysis.Device history record: a review of the device history record (dhr) confirmed that the device met specification prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.Labeling review: a labeling review did not reveal any anomalies as it states: undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and or lead failure are a known risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation.Risk review: a risk review was completed and confirmed that the event of undesired sensations was defined in the risk documentation.Investigation conclusion: based on a thorough review of the reported complaint, this investigation is assigned a probable cause of known inherent risk of device.

• Brand Name: LINEAR? ST
• 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: 23790997
• Report Number: 3006630150-2025-11400
• Device Sequence Number: 10470577
• Product Code: LGW
• UDI-Device Identifier: 08714729784067
• UDI-Public: (01)08714729784067(17)270616(10)7166888
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 03/30/2026

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 Model Number: SC-2218-50E
• Device Catalogue Number: SC-2218-50E
• Device Lot Number: 7166888
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 06/16/2025
• 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: 62 YR
• Patient Sex: Female
• Patient Race: White