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

Model Number	SC-2317-50
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: pro code: qrb.Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2317500, model: sc-2317-50, serial: (b)(6), batch: 7074830, udi: (b)(4).Product family: scs-ipg-r-mri, upn: m365sc12320, model: sc-1232, serial: (b)(6), batch: 519462, udi: (b)(4).Product family: scs-lead fixation, upn: m365sc43180, model: sc-4318, batch: 27488086, udi: (b)(4).
Event or Problem Description
It was reported that the patient experienced inadequate stimulation.It was noted that the right spinal cord stimulation (scs) lead had high impedances.The patient underwent a revision procedure wherein the implantable pulse generator (ipg) and leads were replaced.No further information could be obtained.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation.It was noted that the right spinal cord stimulation (scs) lead had high impedances.The patient underwent a revision procedure wherein the implantable pulse generator (ipg) and leads were replaced.No further information could be obtained.Additional information was received that the patient was doing well postoperatively.All explanted components were discarded and will not be returned.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation.It was noted that the right spinal cord stimulation (scs) lead had high impedances.The patient underwent a revision procedure wherein the implantable pulse generator (ipg) and leads were replaced.No further information could be obtained.Additional information was received that the patient was doing well postoperatively.All explanted components were discarded and will not be returned.
Additional Manufacturer Narrative
D2b: pro code: qrb.Additional suspect medical device components involved in the event: product family: scs-linear leads.Upn: m365sc2317500.Model: sc-2317-50.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).Product family: scs-ipg-r-mri.Upn: m365sc12320.Model: sc-1232.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).Product family: scs-lead fixation.Upn: m365sc43180.Model: sc-4318.Batch: 27488086.Udi: (b)(4).Investigation results: the devices were not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed these devices met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation.It was noted that the right spinal cord stimulation (scs) lead had high impedances.The patient underwent a revision procedure wherein the implantable pulse generator (ipg) and leads were replaced.No further information could be obtained.Additional information was received that the patient was doing well postoperatively.All explanted components were discarded and will not be returned.
Additional Manufacturer Narrative
This report is being submitted to correct the additional mfr narrative (h11) in section h, device manufacturers only of supplemental mdr 2.D2b: pro code: qrb.Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2317500, model: sc-2317-50, serial: (b)(6), batch: 7074830, udi: (b)(4).Product family: scs-ipg-r-mri upn: m365sc12320, model: sc-1232, serial: (b)(6), batch: 519462, udi: (b)(4).Product family: scs-lead fixation upn: m365sc43180, model: sc-4318, batch: 27488086, udi: (b)(4).Sc-2317-50 sn: (b)(6).Investigation results: the leads were not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed these devices met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.Sc-1232 sn: (b)(6).Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Medica inspection: media inspection confirmed the presence of high impedances.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• Brand Name: INFINION? CX
• 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 ; * 00646
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24434622
• Report Number: 3006630150-2026-01080
• Device Sequence Number: 21407041
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/08/2026

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: 07/11/2023
• Device Model Number: SC-2317-50
• Device Catalogue Number: SC-2317-50
• Device Lot Number: 7074906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 04/24/2026; 04/24/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/13/2026; 05/07/2026; 05/08/2026
• Date Device Manufactured: 07/11/2021
• 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: 80 YR
• Patient Sex: Female