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	03/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inadequate stimulation and charging issues due to high impedances on the right lead.Program optimization was attempted and was unsuccessful.As a result, the patient underwent a revision procedure wherein the spinal cord stimulator (scs) lead and implantable pulse generator (ipg) were replaced.The patient was reported to be doing well postoperatively.The explanted devices were not returned.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation and charging issues due to high impedances on the right lead.Program optimization was attempted and was unsuccessful.As a result, the patient underwent a revision procedure wherein the spinal cord stimulator (scs) lead and implantable pulse generator (ipg) were replaced.The patient was reported to be doing well postoperatively.The explanted devices were not returned.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in (b)(6) 2026.Block d.2b; additional applicable product code: qrb.Additional suspect medical device components involved in the event: model number/catalog number: sc-1160.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: spectra wavewriter ipg kit.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4318.Serial number: n/a.Batch/lot number: 22420722.Model/catalog description: clik x anchor sterile kit.Unique identifier (udi) #: (b)(4).Investigation results the implantable pulse generator (ipg), spinal cord stimulator (scs) lead, and anchor 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.Media review review of the provided image confirmed the reported issue of high impedance.No additional observations were noted in the media.Similar complaint review a review of complaints with similar reported conditions was completed.The assessment did not identify any emerging trends, meaningful commonalities, or similar complaints requiring further escalation.Based on the review results, no adverse trend was identified; therefore, no additional escalation or action is required at this time.Investigation conclusion: based on a thorough review of the reported complaint, an investigation conclusion code of cause not established was assigned to the investigation for all components.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in march 2026.Block d.2b; additional applicable product code: qrb.Additional suspect medical device components involved in the event: model number/catalog number: sc-1160, serial number: (b)(6), batch/lot number: 340488, model/catalog description: spectra wavewriter ipg kit, unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4318, batch/lot number: 22420722, model/catalog description: clik x anchor sterile kit, unique identifier (udi) #: (b)(4).Investigation results, the implantable pulse generator (ipg), spinal cord stimulator (scs) lead, and anchor 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.Media review review of the provided image confirmed the reported issue of high impedance.No additional observations were noted in the media.Similar complaint review, a review of complaints with similar reported conditions was completed.The assessment did not identify any emerging trends, meaningful commonalities, or similar complaints requiring further escalation.Based on the review results, no adverse trend was identified; therefore, no additional escalation or action is required at this time.Investigation conclusion: based on a thorough review of the reported complaint, an investigation conclusion code of cause not established was assigned to the investigation for all components.

• 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 -260
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50234762
• Report Number: 3006630150-2026-05861
• Device Sequence Number: 10297257
• Product Code: LGW
• UDI-Device Identifier: 08714729861614
• UDI-Public: (01)08714729861614(17)200805(10)5079010
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/18/2026

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: 08/05/2020
• Device Model Number: SC-2317-50
• Device Catalogue Number: SC-2317-50
• Device Lot Number: 5079010
• 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: 08/25/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 08/06/2018
• 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: 81 YR
• Patient Sex: Female