MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION INFINION? 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2316-70
Medical Device Problem Codes	High impedance (1291); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients lead had high impedances, and an x-ray confirmed lead migration.The patient underwent an explant procedure.All explanted devices were discarded by the medical facility.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-splitters, upn: m365sc3400300.Model: sc-3400-30.Serial: (b)(6).Batch: 17259170.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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21909652
• Report Number: 3006630150-2025-02781
• Device Sequence Number: 15631450
• Product Code: LGW
• UDI-Device Identifier: 08714729797821
• UDI-Public: (01)08714729797821(17)150824(10)16312843
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 04/25/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/24/2015
• Device Model Number: SC-2316-70
• Device Catalogue Number: SC-2316-70
• Device Lot Number: 16312843
• 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: 04/02/2025
• Initial Report FDA Received Date: 04/25/2025
• 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: 74 YR
• Patient Sex: Female