MAUDE Adverse Event Report: SPR Therapeutics SPRINT; Peripheral Nerve Stimulator

Catalog Number	9600-9288
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Pain (1994); Nodule (4551)
Date of Event	08/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient developed an infection at their lead implant site with a painful lump on their back, accompanied by a fever.The patient presented at the emergency department (ed) for evaluation of the issue and was ultimately admitted to the hospital.The patient was prescribed antibiotics, an ultrasound guided needle aspiration was performed to drain fluid from the bump, and their leads were removed prior to the end of treatment.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The patient developed a painful lump on their back, accompanied by a fever.The lump measured approximately 2-3 inches in diameter and surrounded their lead targeting the l4 medial branch of the dorsal ramus.The patient presented at the emergency department (ed) for evaluation of the issue and was ultimately admitted to the hospital and started on antibiotics.While hospitalized, the patient received a computed tomography (ct) scan and serial blood draws (i.E., every 6 hours) for characterization of the issue.Per an update provided by a representative in contact with the patient's physician, the patient also received magnetic resonance imaging (mri) with the lead still implanted.Note that the sprint pns system is mr unsafe; the clinician instructions for use advise to "pull out the lead(s) and remove all other system components from a patient before an mri examination is performed".Based on the results of the diagnostic imaging, the suspected infection was perceived to be superficial in nature, however an ultrasound-guided needle aspiration was performed to drain the fluid from the bump.Despite the serial blood draws and fluid aspiration, the bacteria causing the infection remains unidentified as of the time of this investigation.Per a representative in contact with the patient, the patient remained hospitalized for a total of 5 days in association with this issue.The patient completed a 7-day course of antibiotics for treatment of the issue and had their lead removed while hospitalized, prior to the planned end of treatment date.The patient's acute symptoms had reportedly resolved by the time of this investigation, however a residual bump remained on their skin per an update provided by a representative in contact with the patient.If additional information becomes available regarding complete resolution of the issue, 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 ; +1(216)378-9067
• MDR Report Key: 50715518
• Report Number: 3011035812-2026-00011
• Device Sequence Number: 21479340
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/10/2026

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: 9600-9288
• Device Lot Number: 505892
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/10/2026
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male