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	Dural Tear (1417); Cerebrospinal Fluid Leakage (1772); Headache (1880); Neck Pain (2433)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc221850e0.Model: sc-2218-50e.Serial: (b)(6).Batch: 7150128.
Event or Problem Description
It was reported that the patient experienced neck pain and headache.The physician determined that the headache was due to cerebrospinal fluid (csf) leakage during the trial procedure when advancing the needle and the patient moving on the table.The patient was administered medication for the dural puncture.The patient underwent a lead pull procedure, and the symptoms resolved.The explanted leads were discarded by the medical facility.
Additional Manufacturer Narrative
Correction to initial emdr in blocks f10, g3 and h6.Block g3 should have been 12sep2024.Additional suspect medical device component involved in the event: product family: scs-linear leads upn: m365sc221850e0 model: sc-2218-50e serial: (b)(6).Batch: 7150128 udi (b)(4).
Event or Problem Description
It was reported that the patient experienced neck pain and headache.The physician determined that the headache was due to cerebrospinal fluid (csf) leakage during the trial procedure when advancing the needle and the patient moving on the table.The patient was administered medication for the dural puncture.The patient underwent a lead pull procedure, and the symptoms resolved.The explanted leads were discarded 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: 20431229
• Report Number: 3006630150-2024-06870
• Device Sequence Number: 20730323
• Product Code: LGW
• UDI-Device Identifier: 08714729784067
• UDI-Public: (01)08714729784067(17)260524(10)7146945(21)7146945
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 07/02/2026

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: 05/24/2026
• Device Model Number: SC-2218-50E
• Device Catalogue Number: SC-2218-50E
• Device Lot Number: 7146945
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 04/09/2026; 06/04/2026
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 04/30/2026; 07/02/2026
• Date Device Manufactured: 05/24/2024
• 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: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male