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 Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patients spinal cord stimulator (scs) leads were replaced with an mri compatible device due to lead fracture.The explanted leads were discarded by the medical facility and will not be returned.
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: product family: scs-linear leads, upn: m365sc2316500, model: sc-2316-50, serial: (b)(6), batch: 16098105, udi: ((b)(4).
Event or Problem Description
It was reported that the patients spinal cord stimulator (scs) leads were replaced with an mri compatible device due to lead fracture.The explanted leads were discarded by the medical facility and will not be returned.Additional information was received that the patient was doing well postoperatively.

• 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: 22165469
• Report Number: 3006630150-2025-04068
• Device Sequence Number: 7788856
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: (01)08714729797814(17)151021(10)16456789
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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,Followup
• Report Date (Section B): 07/01/2025

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: 10/21/2015
• Device Model Number: SC-2316-50
• Device Catalogue Number: SC-2316-50
• Device Lot Number: 16456789
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/01/2025
• Date Device Manufactured: 10/21/2013
• 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: 63 YR
• Patient Sex: Male