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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a trial procedure a nerve was tweaked that caused increase pain.No further information has been obtained.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads upn: m365sc231650e0 model: sc-2316-50e serial: (b)(6).Batch: 7279702.Udi: (b)(4).
Event or Problem Description
It was reported that during a trial procedure a nerve was tweaked that caused increase pain.No further information has been obtained.Additional information received that the physician believed that the patients issue was not device related as it was found out that the patient had a cyst at the entry point of t12 which the physician believed could be the cause of the nerve pain.
Event or Problem Description
It was reported that during a trial procedure a nerve was tweaked that caused increase pain.No further information has been obtained.Additional information received that the physician believed that the patients issue was not device related as it was found out that the patient had a cyst at the entry point of t12 which the physician believed could be the cause of the nerve pain.Additional information received that patient underwent an epidural after the trial to alleviate the symptoms.The patient had relief from the trial and wanted to move forward with the permanent scs implant.The trial leads were disposed by the facility.

• 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: 22784939
• Report Number: 3006630150-2025-06406
• Device Sequence Number: 8256610
• Product Code: LGW
• UDI-Device Identifier: 08714729837145
• UDI-Public: (01)08714729837145(17)270211(10)7093151
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 11/19/2025

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: 7093151
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 10/29/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 10/08/2025; 11/19/2025
• Date Device Manufactured: 02/11/2025
• 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: 70 YR
• Patient Sex: Male