MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Infinion? CX; stimulator, spinal-cord, totally implanted for pain relief

Model Number	SC-2317-70
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d.2b; additional applicable product code: lgw, qrb additional suspect medical device components involved in the event: model number/catalog number: sc-2317-70 serial number: (b)(6).Batch/lot number: 7080791 model/catalog description: infinion cx lead kit, 70cm unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4318 batch/lot number: 34122413 model/catalog description: clik x anchor sterile kit unique identifier (udi) #: (b)(4).Model number/catalog number: sc-1232 serial number: (b)(6).Batch/lot number: 760449 model/catalog description: wavewriter alpha 32 ipg kit unique identifier (udi) #: (b)(4).Sc-2317-70 (sn (b)(6).Investigation results, media review, device analysis: 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.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 patients lead had high impedances.All components were explanted and will not be returned per hospital policy.The patient was doing well postoperatively.

• 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: 25864055
• Report Number: 3006630150-2026-05053
• Device Sequence Number: 14842299
• Product Code: LGW
• UDI-Device Identifier: 08714729861638
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/21/2026

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: 08/14/2024
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 7079781
• 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: 06/22/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 08/15/2022
• 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: 74 YR
• Patient Sex: Male
• Patient Race: White