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); Skin Inflammation/ Irritation (4545)
Date of Event	09/25/2025
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: m365sc231670e0 model: sc-2316-70e serial: (b)(6).Batch: 7095875 udi: (b)(4).
Event or Problem Description
It was reported that the patient experienced pain in the testicular region and had a hard time urinating even though his bladder was full.The physician prescribed vicodin; however, the pain persisted.It was unknown if the said symptoms were device related.No further information could be obtained despite good faith efforts.
Event or Problem Description
It was reported that the patient experienced pain in the testicular region and had a hard time urinating even though his bladder was full.The physician prescribed vicodin; however, the pain persisted.It was unknown if the said symptoms were device related.Additional information was received that the patients symptoms had subsided.It was believed that the symptoms were caused by irritated nerve during trial procedure.The patients trial leads were pulled, and the explanted leads were not returned as they were discarded by the medical 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: 23353949
• Report Number: 3006630150-2025-09395
• Device Sequence Number: 8863657
• Product Code: LGW
• UDI-Device Identifier: 08714729837145
• UDI-Public: (01)08714729837145(17)270729(10)7095807
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 11/12/2025

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: 7095807
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/12/2025
• Date Device Manufactured: 07/29/2025
• 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: 47 YR
• Patient Sex: Male