MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION LINEAR? 3-6; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2366-50
Medical Device Problem Codes	High impedance (1291); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.D2b: additional pro code selection that applies to the indication of this device - .Additional suspect medical device components involved in the event: product family: scs-linear leads upn: m365sc2366500, model: sc-2366-50, serial: (b)(6), batch: 16527477, udi: (b)(4).Product family: scs-extension upn: m365sc3138550, model: sc-3138-55, serial: (b)(6), batch: 16795971, udi: (b)(4).Product family: scs-extension upn: m365sc3138550, model: sc-3138-55, serial: (b)(6), batch: 16795971, udi: (b)(4).
Event or Problem Description
It was reported that these spinal cord stimulation (scs) devices were replaced due to high impedances.The patient underwent a lead and lead extension revision procedure, wherein two leads and two lead extensions were explanted and replaced.The devices were retained by the facility and will not be returned for analysis.Postoperatively, the patient was provided with several discharge options following the procedure.Coverage was achieved in both upper extremities, including areas with overlapping paresthesia.
Additional Manufacturer Narrative
Correction to the initial mdr in h6.B3: approximated based on the date the manufacturer became aware of the event d2b: additional pro code selection that applies to the indication of this device - .Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2366500, model: sc-2366-50, serial: (b)(6), batch: 16527477, udi: (b)(4).Product family: scs-extension, upn: m365sc3138550, model: sc-3138-55, serial: 590009, batch: 16795971, udi: (b)(4).Product family: scs-extension, upn: m365sc3138550, model: sc-3138-55, serial: (b)(6), batch: 16795971, udi: (b)(4).
Event or Problem Description
It was reported that these spinal cord stimulation (scs) devices were replaced due to high impedances.The patient underwent a lead and lead extension revision procedure, wherein two leads and two lead extensions were explanted and replaced.The devices were retained by the facility and will not be returned for analysis.Postoperatively, the patient was provided with several discharge options following the procedure.Coverage was achieved in both upper extremities, including areas with overlapping paresthesia.

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22767516
• Report Number: 3006630150-2025-06334
• Device Sequence Number: 20866604
• Product Code: LGW
• UDI-Device Identifier: 08714729789574
• UDI-Public: (01)08714729789574(17)151113(10)16527477
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 03/04/2026

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: 11/13/2015
• Device Model Number: SC-2366-50
• Device Catalogue Number: SC-2366-50
• Device Lot Number: 16527477
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 08/09/2025
• Supplement Report FDA Received Date: 03/04/2026
• Date Device Manufactured: 11/13/2013
• 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: 39 YR
• Patient Sex: Female