MAUDE Adverse Event Report: SPR THERAPEUTICS SPRINT; PERIPHERAL NERVE STIMULATOR

Catalog Number	9244-6001B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Inflammation (1932)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced significant discomfort in their posterior thigh and difficulty moving their leg immediately following lead placement that did not improve over several days.Patient presented in the er eleven days after lead placement with worsening leg pain and perceived hardening of the area around their sciatic lead.Both leads were removed.The patient was admitted to the hospital for further monitoring and treatment of the infection.While admitted, the patient was prescribed three types of antibiotics.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The complaint reports that the patient experienced significant discomfort in their posterior thigh and difficulty moving their leg immediately following placement of a lead targeting the sciatic nerve.The discomfort was present in the absence of stimulation and the patient's implanting physician initially suspected it was discomfort attributable to the implant procedure.The patient was prescribed pain medication (type not specified) for the issue and advised to not turn stimulation for the sciatic lead on until discomfort resolved.Four days following sciatic lead placement, the patient's stimulation parameters were adjusted to resolve motor activation being observed with stimulation.The patient was still experiencing discomfort at this time and was advised to leave stimulation at a comfortable (i.E., lower) intensity level and contact their physician for any continued issues with pain.Eleven days after sciatic lead placement, the patient presented at the emergency room (er) with worsening leg pain and perceived hardening of the area around their sciatic lead.The patient's sciatic and femoral leads were both removed at the er, and removal of the sciatic lead resulted in the expression of foul-smelling purulent discharge from the exit site.Note that there was no report of any issues experienced with the femoral lead.The patient also experienced redness around the sciatic lead exit site and the area was marked by er staff to be monitored for spreading.The patient was admitted to the hospital for further monitoring and treatment of the infection; while admitted, the patient was prescribed three antibiotics (types not specified in the complaint report).Note that there was no report of a culture to characterize the issue or any additional treatments performed while the patient was admitted.No additional information regarding resolution of the issue or the patient's hospitalization status was available at the time of this investigation.If additional information becomes available, this investigation will be updated.It is not suspected that the sprint product was faulty or had any specific deficiency based on the information available in this report.

• Brand Name: SPRINT
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd.; suite 500; cleveland OH 44122
• Manufacturer (Section G): SPR THERAPEUTICS; 22901 millcreek blvd.; suite 500; cleveland OH 44122
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; suite 500; cleveland, OH 44122
• MDR Report Key: 22976793
• Report Number: 3011035812-2025-00010
• Device Sequence Number: 21075872
• Product Code: NHI
• UDI-Device Identifier: 00850022775079
• UDI-Public: (01)00850022775079(17)260905(10)83344085
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K223306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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: Health Professional
• Device Expiration Date: 09/05/2026
• Device Catalogue Number: 9244-6001B
• Device Lot Number: 83344085
• 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: 08/08/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female