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

Catalog Number	9600-9244-60
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a lead fracture and experienced pain and a suspected infection.Patient was hospitalized for surgical removal of the lead and was prescribed iv antibiotics.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The complaint reports that the patient experienced a suspected infection secondary to a lead fracture.The patient was implanted with a single-lead sprint system targeting the tibial nerve.The patient began experiencing persistent lead connect errors (lces) beginning around three weeks after the lead was implanted.Approximately two weeks after the issue began, the patient met with an spr representative for in-person troubleshooting, however they remained unable to resolve the issue.Three days after the attempted in-person troubleshooting, the patient's physician relayed to the spr representative that the patient's lead had fractured and a piece of the lead had been left behind under the patient's skin.The day after the remnant was discovered, the patient presented at the emergency room (er) with severe leg pain and concerns for infection.The patient received intravenous (iv) antibiotics and had the lead remnant surgically removed before being sent home the same day.The following day, the patient returned to the er with continued pain and concerns that the site still looked infected.The patient was hospitalized for further evaluation of the issue and received additional iv antibiotics for treatment.The patient received a computed tomography (ct) scan and ultrasound of the affected area; however, no information regarding the results of these diagnostic tests was available at the time of this investigation.The patient continued to have pain in their leg for at least a week after the lead fragment was surgically removed, citing feeling like their leg was "on fire".Per an update provided by the patient two weeks after lead fragment removal, the infection had reportedly resolved.The patient reported continuing to take pain medication for incision site pain, however noted that their pain level was improving gradually.Given that the infection resolved and the residual pain was reported to be decreasing, no lasting adverse effects are anticipated.

• 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: 50068428
• Report Number: 3011035812-2026-00007
• Device Sequence Number: 16006619
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)270719(10)505863
• 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: 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): 07/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9600-9244-60
• Device Lot Number: 505863
• 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: 06/30/2026
• Initial Report FDA Received Date: 07/29/2026
• 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: 67 YR
• Patient Sex: Male