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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing inadequate pain relief during the trial procedure period.During spinal cord stimulation (scs) lead pull an x-ray revealed the leads had migrated.The patient was doing well postoperatively.The explanted leads will not be returned per facility policy.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred between the trial period from the date manufacturer became aware of the event additional suspect medical device component involved in the event: model number/catalog number: sc-2316-70e, serial number: (b)(6), batch/lot number: 7098689, model/catalog description: 1x16 perc lead trial kit, 70 cm, unique identifier: (b)(4).
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred between the trial period from the date manufacturer became aware of the event additional suspect medical device component involved in the event: model number/catalog number: sc-2316-70e serial number: (b)(6) batch/lot number: 7098689 model/catalog description: 1x16 perc lead trial kit, 70 cm unique identifier: (b)(4).Investigation results: the spinal cord stimulator (scs) trial leads were not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed these devices 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 patient was experiencing inadequate pain relief during the trial procedure period.During spinal cord stimulation (scs) lead pull an x-ray revealed the leads had migrated.The patient was doing well postoperatively.The explanted leads will not be returned per facility policy.

• 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: 24595128
• Report Number: 3006630150-2026-01498
• Device Sequence Number: 20981432
• Product Code: LGW
• UDI-Device Identifier: 08714729837145
• UDI-Public: (01)08714729837145(17)271218(10)7098626
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 05/15/2026

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 Model Number: SC-2316-70E
• Device Catalogue Number: SC-2316-70E
• Device Lot Number: 7098626
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 04/19/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/15/2026
• Date Device Manufactured: 12/18/2025
• 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: 66 YR
• Patient Sex: Female