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

Model Number	SC-2316-70E
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Rash (2033)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads.Upn: m365sc231670e0.Model: sc-2316-70e.Serial: (b)(6).Batch: 7097534.Udi: (b)(4).
Event or Problem Description
It was reported that while undergoing trial the patient was experiencing rib stimulation at end of trial and noticed that one of the cables was disconnected.The patient was also experiencing rash from the tape.The patient completed the trial procedure.
Additional Manufacturer Narrative
Investigation result: the device was not returned to boston scientific for analysis.Device history record: a review of the device history record (dhr) confirmed that the device met specification prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.Labeling review: a labeling review did not reveal any anomalies as it states: lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief, tissue reaction to implanted materials can occur, 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 and persistent pain at the ipg or lead site are known risks with the use of spinal cord stimulation (scs).Investigation conclusion: based on a thorough review of the reported complaint, this investigation is assigned a probable cause of known inherent risk of device.
Event or Problem Description
It was reported that while undergoing trial the patient was experiencing rib stimulation at end of trial and noticed that one of the cables was disconnected.The patient was also experiencing rash from the tape.The patient completed the trial procedure.Additional information stated that the facility disposed of devices.

• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24093176
• Report Number: 3006630150-2026-00365
• Device Sequence Number: 10468674
• Product Code: LGW
• UDI-Device Identifier: 08714729837145
• UDI-Public: (01)08714729837145(17)271016(10)7097478
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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-2316-70E
• Device Catalogue Number: SC-2316-70E
• Device Lot Number: 7097478
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 10/16/2025
• 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: 52 YR
• Patient Sex: Male