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

Catalog Number	9600-9244-60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced a staphylococcal infection in their shoulder joint and an infectious disease physician evaluating the patient further suspected that the patient was septic.The patient was hospitalized, prescribed antibiotics including the placement of a picc line, a joint washout procedure was performed, and their lead was removed prior to the planned end of treatment.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The patient experienced severe pain in their left shoulder joint during sprint treatment targeting the axillary nerve.The patient additionally experienced pain extending medially to their left anterior chest and distally to their left elbow in association with this issue.It is not clear from the information provided if the patient experienced any other symptoms of infection in addition to the reported pain.The patient presented at the emergency room (er) for evaluation of the issue and was ultimately admitted to the hospital for further assessment and treatment.While hospitalized, the patient was diagnosed with a staphylococcal infection in their shoulder joint.An infectious disease physician evaluating the patient reportedly further suspected that the patient was septic.Note that information regarding cultures or other diagnostic testing used to inform these diagnoses was not available for this investigation.The patient was prescribed antibiotics for the treatment of this issue and their lead was removed prior to the planned end of treatment date.An update provided by a representative in contact with the patient further mentions that the patient had a peripherally inserted central catheter (picc) line inserted, suggesting that the patient was receiving the antibiotics intravenously.The update additionally states that a joint washout procedure was performed by an orthopedic physician for further treatment of the issue.The most recent update provided by the representative in contact with the patient states that the patient was expected to be discharged from the hospital on the date of the last contact with the patient, approximately two weeks after the issue began.The patient's picc line was expected to be removed prior to the discharge, and the patient was going to be transferred to an assisted living facility.Note that the patient was in an assisted living facility prior to the onset of this issue.No additional information regarding the resolution of this issue 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: 50916269
• Report Number: 3011035812-2026-00012
• Device Sequence Number: 5344887
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/28/2026

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: 9600-9244-60
• Device Lot Number: 506470
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/28/2026
• 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: 79 YR
• Patient Sex: Female