MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Infinion? Pro; stimulator, spinal-cord, totally implanted for pain relief

Model Number	SC-2318-70
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Unspecified Respiratory Problem (4464)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced lead migration due to a fall.It was noted that lead migration was confirmed through imaging, however, the patient still received good stimulation coverage.
Additional Manufacturer Narrative
Block d.2b; additional applicable product code: qrb.Additional suspect medical device component involved in the event: model number/catalog number: sc-2318-70.Serial number: (b)(6).Batch/lot number: 5004191.Model/catalog description: infinion pro lead kit, 16 contact, 70 cm.Unique identifier (udi) #: (b)(4).

• Brand Name: Infinion? Pro
• 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: 50202725
• Report Number: 3006630150-2026-05744
• Device Sequence Number: 17513493
• Product Code: LGW
• UDI-Device Identifier: 00191506018733
• UDI-Public: (01)00191506018733(17)270429(10)5005101
• 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
• 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): 10/02/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SC-2318-70
• Device Catalogue Number: SC-2318-70
• Device Lot Number: 5005101
• 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: 07/16/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 04/29/2025
• 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: 44 YR
• Patient Sex: Male