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); Unexpected Therapeutic Results (1631); Charging Problem (2892)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced inadequate stimulation and more frequent charging of the implantable pulse generator (ipg).High impedance readings were discovered on several contacts of the thoracic leads.Therefore, the patient was hospitalized and underwent a revision procedure during which the scs system was explanted and replaced with a new ipg and two new leads.The patient has been discharged from the hospital and has recovered postoperatively.The explanted devices will not be returned as they were discarded by the medical facility.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in july 2024.Additional suspect medical device component involved in the event: product family: scs-ipg-r, upn: m365sc11320, model: sc-1132, serial: (b)(6), batch: 16208672; product family: scs-linear leads, upn: m365sc2316700, model: sc-2316-70, serial: (b)(6), batch: 15621589.

• 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: 21701626
• Report Number: 3006630150-2025-01906
• Device Sequence Number: 20800281
• Product Code: LGW
• UDI-Device Identifier: 08714729797821
• UDI-Public: 08714729797821
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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: 10/25/2014
• Device Model Number: SC-2316-70
• Device Catalogue Number: SC-2316-70
• Device Lot Number: 15621589
• 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: 03/04/2025
• Initial Report FDA Received Date: 03/26/2025
• 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; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female