MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Infinion? 16; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-2316-50E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a trial procedure, the physician successfully entered the epidural space through the t12 and t11 interspace using standard tuohy needle that is a part of the infinion trial kit.The patient complained of extreme discomfort upon physician advancing the lead.Posterior lead placement was confirmed under fluoroscopy.Physician then attempted to advance the lead through alternative trajectory and aborted after patient complained of extreme discomfort once again.The lead was discarded.

• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50101569
• Report Number: 3006630150-2026-05452
• Device Sequence Number: 10040203
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: (01)08714729797807(17)280325(10)7327953
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

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-2316-50E
• Device Catalogue Number: SC-2316-50E
• Device Lot Number: 7327953
• 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: 07/06/2026
• Supplement Date Received by Manufacturer: 07/31/2026; 08/28/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/28/2026; 09/22/2026
• Date Device Manufactured: 03/26/2026
• 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 Age: 45 YR
• Patient Sex: Male