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	Fever (1858); Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	03/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.Sprint was placed in a open wound following a surgical procedure.The patient reported fever and lower leg swelling approximately one month after implant.The patient had an infection that required a surgical debridement and lead remnant removal.Patient was admitted to the hospital and prescribed antibiotics.Blood cultures were performed however, results were not available at the time of this investigation.The physician suspected the infection might be from the surgical site and the patient had reported part of their wound was slow healing.Note that the sprint clinician instructions for use states "use caution when delivering stimulation near an unhealed surgical incision.Doing so could cause a surgical incision to re-open or fail to heal properly".Based on available information at time of review, reviewer is unable to determine whether the wound infection was caused by the surgical procedure or sprint procedure.Patient reported they have been discharged from the hospital, healing, remain on antibiotics and seeing an infectious disease physician.
Event or Problem Description
Patient had an infection that required a surgical debridement, lead remnant removal, antibiotics, and hospital admission.

• 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: 21763454
• Report Number: 3011035812-2025-00005
• Device Sequence Number: 8758950
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)251121(10)76914219
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/03/2025

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: 11/21/2025
• Device Catalogue Number: 9600-9244-60
• Device Lot Number: 76914219
• 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: 03/10/2025
• Initial Report FDA Received Date: 04/03/2025
• 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: 34 YR
• Patient Sex: Male