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

Model Number	SC-2218-70E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Speech Disorder (4415); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) trial patient was taken to the emergency room due to a possible stroke and thrombosis.The patient experienced slurred speech and immobility of the right arm.The physician assessed that the device nor the procedure caused or contributed to the patients complications as the patient had suspended their pre-existing anticoagulant medication for a prolonged period of time prior to the trial procedure.The patients trial leads were removed the day after the patients symptoms began and the patient has been discharged from the hospital.Additionally, the patient was placed back on their anticoagulant medication once again and has since recovered.The removed trial leads will not be returned as they were retained by the medical facility.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc221870e0, model: sc-2218-70e, serial: (b)(6), batch: 7103732.
Additional Manufacturer Narrative
Additional information provided in block h6 additional suspect medical device component involved in the event: product family: scs-linear leads upn: m365sc221870e0 model: sc-2218-70e serial: (b)(6).Batch: 7103732.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) trial patient was taken to the emergency room due to a possible stroke and thrombosis.The patient experienced slurred speech and immobility of the right arm.The physician assessed that the device nor the procedure caused or contributed to the patients complications as the patient had suspended their pre-existing anticoagulant medication for a prolonged period of time prior to the trial procedure.The patients trial leads were removed the day after the patients symptoms began and the patient has been discharged from the hospital.Additionally, the patient was placed back on their anticoagulant medication once again and has since recovered.The removed trial leads will not be returned as they were retained by the medical facility.

• 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: 22057473
• Report Number: 3006630150-2025-03516
• Device Sequence Number: 7634721
• Product Code: LGW
• UDI-Device Identifier: 08714729820741
• UDI-Public: (01)08714729820741(17)260927(10)7103264
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/27/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/27/2026
• Device Model Number: SC-2218-70E
• Device Catalogue Number: SC-2218-70E
• Device Lot Number: 7103264
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/27/2025
• Date Device Manufactured: 09/27/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male