MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION INFINION? 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2316-50
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component(s) involved in the event: model number/catalog number: sc-2316-50.Serial number: no information.Batch/lot number: no information.Model/catalog description: infinion 16 lead kit 50 cm.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation.The patient underwent a procedure where the spinal cord stimulation (scs) leads were relocated.The patient was noted to have recovered post operatively.
Additional Manufacturer Narrative
Additional suspect medical device component(s) involved in the event: model number/catalog number: sc-2316-50.Serial number: no information.Batch/lot number: no information.Model/catalog description: infinion 16 lead kit 50 cm.Udi: (b)(4).A review of the manufacturing documentation for the leads was unable to be performed as the serial number is unknown.The leads remain implanted in the patient.Therefore, a physical analysis could not be performed in our laboratory.A product labeling review identified that the device was used per the instructions for use (ifu) product label.Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure, all of which are known risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation.The leads remain implanted in the patient, and as such physical analysis has not been conducted in our laboratory.However, a labeling review was conducted which determined that the reported event of inadequate stimulation is a known risk associated with the use of the device, as documented in the ifu.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation.The patient underwent a procedure where the spinal cord stimulation (scs) leads were relocated.The patient was noted to have recovered post operatively.No further information regarding the implant date and serial number of the leads has been obtained despite good faith efforts.

• Brand Name: INFINION? 16
• 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
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24407871
• Report Number: 3006630150-2026-01041
• Device Sequence Number: 13221580
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: (01)08714729797814
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SC-2316-50
• Device Catalogue Number: SC-2316-50
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 05/05/2026
• 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 Sex: Unknown