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	Unexpected Therapeutic Results (1631); Charging Problem (2892); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this spinal cord stimulation (scs) patient underwent a procedure due to charging difficulties with the implantable pulse generator (ipg).Additionally, the leads migrated, resulting in inadequate stimulation, which prevented the patient from experiencing sufficient pain relief.The patient underwent an ipg and leads revision procedure wherein their ipg and leads were explanted and replaced.The devices were disposed by the hospital and will not be returned for analysis.Postoperatively, the patient was doing better and satisfied with the new devices.Electrocautery was used.
Additional Manufacturer Narrative
Additional pro code selection that applies to the indication of this device - .B3: estimated based on gfe response from sales representative.Additional suspect medical device components involved in the event: product family: scs-ipg-r, upn: m365sc11600, model: sc-1160, serial: (b)(6), batch: (b)(6), udi: (b)(4).Product family: scs-linear leads, upn: m365sc2366700, model: sc-2366-70, serial: (b)(6), batch: (b)(6), udi: (b)(4).Product family: scs-linear leads, upn: m365sc2366700, model: sc-2366-70, serial: (b)(6), batch: 16494778, udi: (b)(4).Product family: scs-linear leads, upn: m365sc2366700, model: sc-2366-70, serial: (b)(6), batch: 16505320, udi: (b)(4).Product family: scs-linear leads, upn: m365sc2366700, model: sc-2366-70, serial: (b)(6), batch: 16494778, udi: (b)(4).
Additional Manufacturer Narrative
Additional pro code selection that applies to the indication of this device - .B3: estimated based on gfe response from sales representative additional suspect medical device components involved in the event: product family: scs-ipg-r upn: m365sc11600 model: sc-1160 serial: (b)(6) batch: 372173 udi: (01)08714729951254(17)220820(10)372173(21)372173 product family: scs-linear leads upn: m365sc2366700 model: sc-2366-70 serial: 3145190 batch: 3145190 udi: (01)08714729789567(17)211008(10)3145190(21)3145190 product family: scs-linear leads upn: m365sc2366700 model: sc-2366-70 serial: 1003922 batch: 16494778 udi: (01)08714729789567(17)151106(10)16494778(21)1003922 product family: scs-linear leads upn: m365sc2366700 model: sc-2366-70 serial: 1003739 batch: 16505320 udi: (b)(4).Product family: scs-linear leads upn: m365sc2366700 model: sc-2366-70 serial: (b)(6) batch: 16494778 udi: (b)(4).
Event or Problem Description
It was reported that this spinal cord stimulation (scs) patient underwent a procedure due to charging difficulties with the implantable pulse generator (ipg).Additionally, the leads migrated, resulting in inadequate stimulation, which prevented the patient from experiencing sufficient pain relief.The patient underwent an ipg and leads revision procedure wherein their ipg and leads were explanted and replaced.The devices were disposed by the hospital and will not be returned for analysis.Postoperatively, the patient was doing better and satisfied with the new devices.Electrocautery was used.Additional information indicates that in 2013, the patient underwent an implant procedure in which three sc-2366-70 leads were implanted.Subsequently, in 2020, a procedure was reported in which one sc-2366-70 lead (whose serial number is unknown) was replaced due to high impedance.

• 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: 22093064
• Report Number: 3006630150-2025-03713
• Device Sequence Number: 6936003
• Product Code: LGW
• UDI-Device Identifier: 08714729789574
• UDI-Public: (01)08714729789574(17)140601(10)16444931
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 08/07/2025

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: 06/01/2014
• Device Model Number: SC-2366-50
• Device Catalogue Number: SC-2366-50
• Device Lot Number: 16444931
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 08/07/2025
• 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
• Patient Age: 46 YR
• Patient Sex: Female