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

Model Number	SC-2316-50
Medical Device Problem Codes	High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2316500, model: sc-2316-50, serial: (b)(6), batch: 20088706.
Event or Problem Description
It was reported that the patient had several spinal cord stimulation (scs) lead contacts with high impedances, and the patient experienced shocking stimulation.The patient underwent a lead replacement procedure wherein a magnetic resonance imaging (mri) compatible device was implanted, was doing well postoperatively and the explanted device was kept by the 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21127666
• Report Number: 3006630150-2025-00030
• Device Sequence Number: 6829791
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: 08714729797814
• 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: 2017
• Device Explanted Year: 2024
• 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): 01/10/2025

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 Expiration Date: 06/28/2018
• Device Model Number: SC-2316-50
• Device Catalogue Number: SC-2316-50
• Device Lot Number: 19411842
• 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: 12/19/2024
• Initial Report FDA Received Date: 01/10/2025
• Date Device Manufactured: 06/28/2016
• 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: 57 YR
• Patient Sex: Male