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); Blister (4537); Swelling/ Edema (4577)
Date of Event	01/14/2026
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 presented to their implanting physician with pain and swelling surrounding the lead exit site on their left leg.Blood cultures were performed to characterize the suspected infection.The culture reportedly grew serratia marcescens.The patient was admitted to the hospital for treatment of the issue, including administration of intravenous (iv) antibiotics.The patient's leads were removed around the time of initial hospitalization.Per an update provided by a representative in contact with the patient approximately 18 days after their admission to the hospital, the patient remained hospitalized following completion of their prescribed 10-day course of iv antibiotics.The patient reported experiencing complications such as continued swelling of the area surrounding the lead exit site, blistering, and infection spreading to their bloodstream requiring additional antibiotics to be administered.Per an additional update received 1 month after the initial hospital admission, the patient reported that they continued to remain hospitalized.A debridement procedure had been performed for additional treatment of the issue; however, the patient stated they were no longer on any antibiotics at the time of the update.No further information regarding the patient's hospitalization or potential resolution was available at the time of investigation.If additional information becomes available, this investigation will be updated.The patient had sprint leads implanted in both legs simultaneously for bilateral treatment.Note that the patient did not experience any infection symptoms on the contralateral limb (i.E., the issue was localized to the left leg lead).Per follow-up with the patient's physician, the patient is reportedly diagnosed with lupus and has a history of chronic steroid usage.Given the association of both lupus and long-term steroid use with weakened immune systems and a higher risk of infection, it is possible that the patient's medical history unrelated to sprint caused or contributed to the issue.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
The patient was admitted to the hospital with an infection and administered intravenous (iv) antibiotics.The patient's leads were removed.The patient reported experiencing complications such as continued swelling of the area surrounding the lead exit site, blistering, and infection spreading to their bloodstream requiring additional antibiotics to be administered.A debridement procedure was performed for additional treatment of the issue.

• 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: 24445279
• Report Number: 3011035812-2026-00002
• Device Sequence Number: 10254529
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)261130(10)504356
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/25/2026

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: 504356
• 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: 01/26/2026
• Initial Report FDA Received Date: 02/25/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female