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); Erythema (1840); Pain (1994); Ulcer (2274)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The patient experienced redness surrounding their lead exit site approximately three weeks after lead placement.The redness was assessed by their clinician during a follow-up visit, at which time dermabond was applied to secure the lead and prevent dislodgement.Per the complaint report, the patient's lead was removed due to infection concern within the following week.The patient was hospitalized due to psuedomonas aeruginosa infection and progressing ulceration in the area following removal of the lead.While hospitalized, interventions utilized for treatment included surgical debridement, balloon angioplasty, and administration of intravenous (iv) antibiotics (cefepime and linezolid).The patient was further prescribed additional oral antibiotics (ciprofloxacin) following completion of the iv antibiotics.The patient's healing was reportedly complicated by multiple factors including ongoing limb ischemia, adhesive-related skin trauma, and limited access to the appropriate specialized wound care.This resulted in persistent pain, swelling, and functional decline throughout the initial follow-up period.Approximately six months after the onset of the infection, the patient was seen in clinic by their physician, at which time positive signs of healing in the affected area were noted including the formation of healthy granulation tissue.The patient ultimately passed away due to complications experienced in association with a separate infection (i.E., not the issue reported in this complaint), and therefore no further updates on resolution of this issue are available.The patient reportedly has a history of severe peripheral artery disease (pad) with multiple revascularizations and type 2 diabetes mellitus.Both pad and diabetes have been reported to have negative impacts on wound healing ability, particularly in the lower extremity.Therefore, it is possible that the issue reported in this complaint was caused or exacerbated by the patient's medical history unrelated to sprint.It is not suspected that the sprint product was faulty or had any specific deficiency based on the information available in this report.
Event or Problem Description
Patient experienced erythema, and tenderness three weeks post-implantation.Patients lead was removed but despite device explanation, ulceration progressed, and the patient was hospitalized with an infection.Interventions included surgical debridement, balloon angioplasty, and iv antibiotics followed by additional oral antibiotics.

• 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: 24326521
• Report Number: 3011035812-2026-00001
• Device Sequence Number: 21217741
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)250407(10)73619164
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K223306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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
• Device Expiration Date: 04/07/2025
• Device Catalogue Number: 9600-9244-60
• Device Lot Number: 73619164
• 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: 01/14/2026
• Initial Report FDA Received Date: 02/12/2026
• 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: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female