MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Linear? 3-4; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-2352-70
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one of the patient's spinal cord stimulator (scs) lead had high impedance.The patient underwent a lead replacement procedure and was doing well postoperatively.The explanted lead was retained by the medical facility and will not be returned.
Event or Problem Description
It was reported that one of the patient's spinal cord stimulator (scs) lead had high impedance.The patient underwent a lead replacement procedure and was doing well postoperatively.The explanted lead was retained by the medical facility and will not be returned.
Additional Manufacturer Narrative
Block b3: exact date approximated based on the date the manufacturer became aware of the event.Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed that this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: the device was not returned for analysis and the complaint as reported could not be confirmed.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable cause for the complaint and the conclusion code cause not established will be used.
Additional Manufacturer Narrative
Block b3: exact date approximated based on the date the manufacturer became aware of the event.Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed that this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: the device was not returned for analysis and the complaint as reported could not be confirmed.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable cause for the complaint and the conclusion code cause not established will be used.

• 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: 50302854
• Report Number: 3006630150-2026-06012
• Device Sequence Number: 18704002
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: (01)08714729789581(17)220626(10)7070805
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/25/2026

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: 06/26/2022
• Device Model Number: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 7070805
• 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: 07/20/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 06/26/2020
• 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: 53 YR
• Patient Sex: Male