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	Unspecified Infection (1930); Pain (1994)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient experienced pain and a suspected infection of their popliteal lead.The patient's leads were removed and the patient was admitted to the hospital and prescribed antibiotics.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The patient had both of their leads removed prior to the planned end of treatment date due to a suspected infection of their popliteal lead.The patient reported "excruciating" pain in the posterior region of their knee beginning the week prior to this complaint being reported.The patient denied experiencing any erythema or drainage from the lead exit site in association with the pain.Per an update provided by a representative in contact with the patient's provider, the patient was admitted to the hospital on the date of lead removal and was discharged the following day.The provider clarified that the hospitalization was primarily for the purpose of ruling out osteomyelitis; no further information was available explaining why osteomyelitis was initially a concern.No information regarding what testing was performed during the patient's hospitalization to characterize the issue (e.G., cultures, diagnostic imaging) was available at the time of this investigation.The patient was prescribed antibiotics for treatment of the issue during and following their hospitalization.The issue resolved with no lasting effects, per an additional update received from the patient's provider.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: 25428730
• Report Number: 3011035812-2026-00004
• Device Sequence Number: 10322539
• Product Code: NHI
• UDI-Device Identifier: 00850022775321
• UDI-Public: (01)00850022775321(17)270730(10)506196
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K223306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 06/08/2026

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: 9244-6001B
• Device Lot Number: 506196
• 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: 05/14/2026
• Initial Report FDA Received Date: 06/08/2026
• 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: 59 YR
• Patient Sex: Male