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); Charging Problem (2892)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a non-device related fall, after which the spinal cord stimulator (scs) leads exhibited new impedances, which resulted in inadequate pain relief.It was also noted that the patient experienced difficulty charging the implantable pulse generator (ipg), including a need for frequent charging.As a result, the patient underwent a procedure wherein the scs leads, ipg, and clik anchor were replaced.The patient was doing well postoperatively, and the explanted device components were not returned due to facility policy.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred two weeks prior to the date the manufacturer became aware of the event.Block d.2b; additional applicable product code: qrb.Additional suspect medical device components involved in the event: model number/catalog number: sc-1232.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: wavewriter alpha 32 ipg kit.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-2317-50.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: nfinion cx lead kit, 50cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4318.Serial number: na.Batch/lot number: 34955918.Model/catalog description: clik x anchor sterile kit.Unique identifier (udi) #: (b)(4).Sc-2317-50 sn: (b)(6).Investigation results the spinal cord stimulator (scs) 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.Media review review of the provided image did not contribute any relevant information to support or further evaluate the reported issue.Investigation conclusion as the devices were not available for further evaluation and insufficient information exists to determine the underlying cause of the observed high impedances or their relationship to the reported fall, this investigation is unable to establish a definitive root cause.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50059523
• Report Number: 3006630150-2026-05354
• Device Sequence Number: 15733125
• Product Code: LGW
• UDI-Device Identifier: 08714729861614
• UDI-Public: (01)08714729861614(17)251211(10)7081167
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/02/2026

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: 12/11/2025
• Device Model Number: SC-2317-50
• Device Catalogue Number: SC-2317-50
• Device Lot Number: 7081167
• 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: 07/06/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 12/12/2023
• 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: 72 YR
• Patient Sex: Male