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); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: estimated based on gfe response from sales representative additional suspect medical device components involved in the event: product family: scs-linear leads upn: m365sc2316500, model: sc-2316-50, serial: (b)(6), batch: 17450629, udi: (b)(4).
Event or Problem Description
It was reported that these spinal cord stimulation (scs) leads were explanted due to impedances.The patient underwent a leads revision procedure wherein their leads were explanted.The leads were discarded by the hospital and will not be returned for analysis.Postoperatively, the patient was doing well.
Additional Manufacturer Narrative
B3: estimated based on gfe response from sales representative, additional suspect medical device components involved in the event: product family: scs-linear leads.Upn: m365sc2316500.Model: sc-2316-50.Serial: (b)(6).Batch: 17450629.Udi: (b)(4).
Event or Problem Description
It was reported that these spinal cord stimulation (scs) leads were explanted due to impedances.The patient underwent a leads revision procedure wherein their leads were explanted.The leads were discarded by the hospital and will not be returned for analysis.Postoperatively, the patient was doing well.Additional information was received stating that the leads impedances were high.As a result, the patient experienced a recurrence of chronic pain, as the leads were not functioning as expected.

• 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: 21965076
• Report Number: 3006630150-2025-03068
• Device Sequence Number: 12792875
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: (01)08714729797814(17)160327(10)17450629
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/12/2025

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: 03/27/2016
• Device Model Number: SC-2316-50
• Device Catalogue Number: SC-2316-50
• Device Lot Number: 17450629
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/12/2025
• Date Device Manufactured: 11/13/2014
• 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: 82 YR
• Patient Sex: Female