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 Codes	Cerebrospinal Fluid Leakage (1772); Headache (1880)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during advancement of the spinal cord stimulation (scs) lead within the epidural space, an inadvertent dural puncture occurred, resulting in cerebrospinal fluid (csf) leakage.Following identification of the csf leak, the patient required admission beyond standard post procedure observation.The patient experienced positional headache when sitting upright and is being managed conservatively with monitoring and bed rest to support potential spontaneous closure of the puncture site.According to the physician's assessment, the complication was directly related to the procedure, and anatomical constraints within the epidural space limited further lead advancement, allowing placement of only one scs lead.The patient underwent a successful epidural blood patch procedure.The dural puncture has since resolved, and the patient has been discharged from the hospital with full clinical recovery and no further treatment required.
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: qrb.
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: qrb.Correction to the initial mdr in block: d5.The lead has not been returned as it remains implanted.As such, physical analysis has not been conducted in our laboratory.However, a labeling review was conducted.A labeling review did not reveal any anomalies and states that possible surgical procedural risks are temporary pain at the implant site, infection, cerebrospinal fluid (csf) leakage and, although rare, epidural hemorrhage, seroma, hematoma and paralysis is a known risk with the use of spinal cord stimulation (scs).A review of the manufacturing documentation for the devices revealed that no anomalies or deviations related to the event occurred during manufacturing.The device was not returned for analysis.A review of the device history record did not identify any manufacturing deviations that could have contributed to the event.A labeling review confirms that csf leakage is a known procedural risk associated with implantation of a spinal cord stimulation (scs) system.However, it was reported that an inadvertent dural puncture occurred during advancement of the scs lead, resulting in cerebrospinal fluid (csf) leakage and subsequent positional headache.The treating physician assessed that the complication was directly related to the procedure, and anatomical constraints contributed to the difficulty in lead advancement.The patient required additional medical management, including an epidural blood patch, and ultimately recovered without further complications.Based on the available information and physician assessment, this investigation is assigned a probable cause of adverse event related to procedure.
Event or Problem Description
It was reported that during advancement of the spinal cord stimulation (scs) lead within the epidural space, an inadvertent dural puncture occurred, resulting in cerebrospinal fluid (csf) leakage.Following identification of the csf leak, the patient required admission beyond standard post procedure observation.The patient experienced positional headache when sitting upright and is being managed conservatively with monitoring and bed rest to support potential spontaneous closure of the puncture site.According to the physicians assessment, the complication was directly related to the procedure, and anatomical constraints within the epidural space limited further lead advancement, allowing placement of only one scs lead.The patient underwent a successful epidural blood patch procedure.The dural puncture has since resolved, and the patient has been discharged from the hospital with full clinical recovery and no further treatment required.

• 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; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24475244
• Report Number: 3006630150-2026-01169
• Device Sequence Number: 21243586
• Product Code: LGW
• UDI-Device Identifier: 08714729789550
• UDI-Public: (01)08714729789550(17)270707(10)7085167
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/30/2026

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: Health Professional
• Device Model Number: SC-2352-50
• Device Catalogue Number: SC-2352-50
• Device Lot Number: 7085167
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/30/2026
• Date Device Manufactured: 07/07/2025
• 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; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female