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	01/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-2317-70 serial number: (b)(6).Batch/lot number: 7076595 model/catalog description: infinion cx lead kit, 70cm unique identifier (udi)#: (b)(4).Model number/catalog number: sc-4318 batch/lot number: 27763817 model/catalog description: clik x anchor sterile kit unique identifier (udi)#: (b)(4).Block d2b: pro code (product code): qrb.
Event or Problem Description
It was reported that the spinal cord stimulator (scs) leads of the patient had impedances.The patient underwent a scs lead replacement procedure, was doing well postoperatively and the explanted devices were kept by the facility.

• 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: 25673434
• Report Number: 3006630150-2026-04517
• Device Sequence Number: 21445824
• Product Code: LGW
• UDI-Device Identifier: 08714729861638
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 09/23/2026

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: 09/26/2023
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 7076591
• 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: 06/01/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 09/26/2021
• 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: 77 YR
• Patient Sex: Male
• Patient Race: White