MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Linear? 3-6; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-2366-70
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the leads had high impedances.The patient underwent a lead replacement procedure and was doing well postoperatively.The explanted devices were not returned.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: model number/catalog number: sc-3138-35.Serial number: (b)(6).Batch/lot number: 7078449.Model/catalog description: lead extension kit 35cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-3138-35.Serial number: (b)(6).Batch/lot number: 7078664.Model/catalog description: lead extension kit 35cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-1232.Serial number: (b)(6).Batch/lot number: 575958.Model/catalog description: wavewriter alpha 32 ipg kit.Unique identifier (udi) #: (b)(4).

• Brand Name: Linear? 3-6
• 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: 50144368
• Report Number: 3006630150-2026-05588
• Device Sequence Number: 10656601
• Product Code: LGW
• UDI-Device Identifier: 08714729789567
• 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: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/06/2025
• Device Model Number: SC-2366-70
• Device Catalogue Number: SC-2366-70
• Device Lot Number: 7075448
• 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: 07/06/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 08/07/2023
• 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: 32 YR
• Patient Sex: Female