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

Model Number	SC-2316-70
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc2316700.Model: sc-2316-70.Serial: (b)(6).Batch: 16420798.
Event or Problem Description
It was reported that the patient was experiencing inadequate pain relief.The patient underwent a revision procedure where the spinal cord stimulator (scs) linear leads were replaced with a paddle lead.The patient was doing well postoperatively, and the explanted leads were not returned due to hospital policy.
Event or Problem Description
It was reported that the patient was experiencing inadequate pain relief.The patient underwent a revision procedure where the spinal cord stimulator (scs) linear leads were replaced with a paddle lead.The patient was doing well postoperatively.The explanted leads were not returned due to hospital policy.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc2316700.Model: sc-2316-70.Serial: (b)(6).Batch: 16420798.Udi: (b)(4).
Event or Problem Description
It was reported that the patient was experiencing inadequate pain relief.The patient underwent a revision procedure where the spinal cord stimulator (scs) linear leads were replaced with a paddle lead.The patient was doing well postoperatively.The explanted leads were not returned due to hospital policy.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: scs-linear leads upn: (b)(6) model: sc-2316-70 serial: (b)(6) batch: 16420798 udi: (b)(4) sc-2316-70 (sn: (b)(6)/(b)(6)) investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed this device 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 all available information, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 20252343
• Report Number: 3006630150-2024-06231
• Device Sequence Number: 12928400
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2026

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 Expiration Date: 10/04/2015
• Device Model Number: SC-2316-70
• Device Catalogue Number: SC-2316-70
• Device Lot Number: 16420798
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 04/16/2026; 05/26/2026
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 04/28/2026; 06/19/2026
• Date Device Manufactured: 10/04/2013
• 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: Male