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

Catalog Number	80106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's lead was removed due to an infection in the knee.The patient was hospitalized for treatment of the issue; treatment reportedly included surgical lavage and drainage of fluid and iv antibiotics.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The complaint reports that the patient's lead was removed due to an infection in the knee.Per follow-up with a representative in contact with the patient, the patient experienced fever, pain, and swelling in association with the reported issue.The patient was hospitalized for treatment of the issue which included surgical lavage and drainage of fluid accumulated in the area of the infection.There was no report of a culture or other testing to further characterize the reported infection.The patient received intravenous (iv) antibiotics in addition to the surgical treatments performed following spread of the infection to the patient's bloodstream, per an update provided by a representative in contact with the patient.The complaint notes that medication was given as well, however no further information was available regarding the type of medication prescribed at the time of the complaint's report, so it is unclear if additional medication was provided in addition to the iv antibiotics.Patient has a history of right knee pain and osteoarthritis.No additional information regarding the patient's status was available at the time of investigation.If additional information becomes available, this investigation will be updated.

• 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: 23864476
• Report Number: 3011035812-2025-00011
• Device Sequence Number: 9299961
• Product Code: NHI
• UDI-Device Identifier: 00850022775093
• UDI-Public: (01)00850022775093(17)261010(10)79592962
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/22/2025

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 Catalogue Number: 80106
• Device Lot Number: 79592962
• 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: 12/04/2025
• Initial Report FDA Received Date: 12/22/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male