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	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent a procedure wherein the lead was explanted and replaced due to impedances.No symptoms or stimulation issues were experienced as a result of this finding.The lead was disposed by the hospital and will not be returned for analysis.Postoperatively, the patient made a normal recovery.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent a procedure wherein the lead was explanted and replaced due to impedances.No symptoms or stimulation issues were experienced as a result of this finding.The lead was disposed by the hospital and will not be returned for analysis.Postoperatively, the patient made a normal recovery.
Additional Manufacturer Narrative
The device was not returned to boston scientific for analysis and the complaint as reported was not able to be confirmed.A review of the device history record (dhr) confirmed that the device met specifications prior to shipping and no manufacturing deviations were noted that could have contributed to the event reported.Therefore, in the absence of device return and analysis the likely root cause could not be established.B3: approximated based on the date the manufacturer became aware of the event.

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24641273
• Report Number: 3006630150-2026-01605
• Device Sequence Number: 9842426
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 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 Expiration Date: 08/22/2015
• Device Model Number: SC-2316-50
• Device Catalogue Number: SC-2316-50
• Device Lot Number: 16309865
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 05/15/2026
• 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: Female