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	Pain (1994)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a new pain in the right ribs during a spinal cord stimulator (scs) trial.The physician confirmed that the nerve got irrigated during the trial procedure and determined this to be the cause of the pain.As a result, the patient underwent an early lead pull procedure, and the pain reportedly improved within a few days.The explanted devices were not returned as they were disposed of by the medical facility.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-2316-50e, serial number: (b)(6), batch/lot number: 7327061, model/catalog description: infinion 16 trial lead kit 50 cm, unique identifier (udi) #: (b)(4).

• 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: 50134744
• Report Number: 3006630150-2026-05545
• Device Sequence Number: 16101203
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: (01)08714729797807(17)280316(10)7322609
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 7322609
• 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: 07/13/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 03/17/2026
• 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: 70 YR
• Patient Sex: Female