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 Code	Inappropriate Device Stimulation of Tissue (4928)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced undesired stimulation on the abdomen and ribs due to the spinal cord stimulator (scs) leads had migrated.The device migration was confirmed thru x-ray imaging.The patient underwent a scs lead replacement procedure and was doing well postoperatively.No further information has been obtained.
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: model number/catalog number: sc-2318-70.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: infinion pro lead kit, 16 contact, 70cm.Unique identifier (udi)#: (b)(4).Block d2b: pro code (product code): qrb.
Additional Manufacturer Narrative
This report is being submitted to correct the (additional mfr narrative field (h11)) in section h, device manufacturers only.Additional suspect medical device component involved in the event: model number/catalog number: sc-4318, batch/lot number: 35501113, model/catalog description: clik x anchor sterile kit, unique identifier (udi)#: (b)(4).
Event or Problem Description
It was reported that the patient experienced undesired stimulation on the abdomen and ribs due to the spinal cord stimulator (scs) leads had migrated.The device migration was confirmed thru x-ray imaging.The patient underwent a scs lead replacement procedure and was doing well postoperatively.No further information has been obtained.

• 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: 25017865
• Report Number: 3006630150-2026-02695
• Device Sequence Number: 10303107
• Product Code: LGW
• UDI-Device Identifier: 00191506018733
• UDI-Public: (01)00191506018733(17)261115(10)5002842
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/01/2026

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-2318-70
• Device Catalogue Number: SC-2318-70
• Device Lot Number: 5002842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Supplement Date Received by Manufacturer: 04/06/2026; 06/15/2026; 09/04/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 04/28/2026; 07/09/2026; 10/01/2026
• Date Device Manufactured: 11/14/2024
• 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: 77 YR
• Patient Sex: Female
• Patient Race: White