MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Linear? 3-4; stimulator, spinal-cord, totally implanted for pain relief

Model Number	SC-2352-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a spinal cord stimulation (scs) patient was admitted to the hospital for evaluation following a stroke.It is unknown whether the stroke was related to the device, stimulation, or any other cause.Further information has not been provided.
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: pjs, lgw.
Event or Problem Description
It was reported that a spinal cord stimulation (scs) patient was admitted to the hospital for evaluation following a stroke.It is unknown whether the stroke was related to the device, stimulation, or any other cause.Further information has not been provided.
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: qrb.Additional suspect medical device components involved in the event: model number/catalog number: sc-2352-50 serial number:(b)(6) batch/lot number: 5057026 model/catalog description: linear 3-4 lead 50 cm unique identifier (udi) #: (b)(4).Correction to the initial mdr in block: d8.

• Brand Name: Linear? 3-4
• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25908446
• Report Number: 3006630150-2026-05277
• Device Sequence Number: 5791524
• Product Code: LGW
• UDI-Device Identifier: 08714729789550
• UDI-Public: (01)08714729789550(17)200510(10)5056664
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 05/10/2020
• Device Model Number: SC-2352-50
• Device Catalogue Number: SC-2352-50
• Device Lot Number: 5056664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 07/22/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 05/11/2018
• 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: Life Threatening; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male