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

Model Number	SC-2318-50
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred eight weeks prior to the date the manufacturer became aware of the event.Block d.2b; additional applicable product code: qrb.Additional suspect medical device component involved in the event: model number/catalog number: sc-4318.Batch/lot number: 37686569.Model/catalog description: clik x anchor sterile kit.Unique identifier (udi)#: (b)(4).
Event or Problem Description
It was reported that the patient was experiencing loss of efficiency from the spinal cord stimulator (scs).It was also stated that the patient's right spinal cord stimulator (scs) lead had migrated two vertebral bodies which was confirmed through xray.The patient had a device optimization was done without success.The patient underwent a lead replacement procedure and the patient was doing well postoperatively.The explanted lead was discarded by the medical facility and will not be returned.

• 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: 50942711
• Report Number: 3006630150-2026-07216
• Device Sequence Number: 9624279
• Product Code: LGW
• UDI-Device Identifier: 00191506018726
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 09/30/2026

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-2318-50
• Device Catalogue Number: SC-2318-50
• Device Lot Number: 5007066
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 01/07/2026
• 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: 74 YR
• Patient Sex: Male