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	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had high impedances on the leads.The patient underwent a spinal cord stimulator (scs) system replacement procedure.The explanted products will not be returned per hospital policy.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.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: 7084612, model/catalog description: infinion cx lead kit, 70cm , unique identifier (udi) #: (b)(4).Model number/catalog number: sc-1232, serial number: (b)(6), batch/lot number: 567413, model/catalog description: wavewriter alpha 32 ipg kit, unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4318, batch/lot number: 32596142, model/catalog description: clik x anchor sterile kit, unique identifier (udi) #: (b)(4).

• 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: 50767166
• Report Number: 3006630150-2026-06747
• Device Sequence Number: 9550840
• Product Code: LGW
• UDI-Device Identifier: 08714729861638
• UDI-Public: (01)08714729861638(17)251119(10)7084413
• 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
• Report Date (Section B): 09/15/2026

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: 11/19/2025
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 7084413
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 11/20/2023
• 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: 89 YR
• Patient Sex: Male