MAUDE Adverse Event Report: SPR THERAPEUTICS SPRINT; PERIPHERAL NERVE STIMULATOR

Catalog Number	9600-9288-6003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812); Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	12/11/2024
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 an infection of their right lead exit site at two different time points during treatment targeting the occipital nerve.Per the complaint report, the patient originally experienced skin irritation and drainage at their right lead exit site two weeks after initial implant.A culture performed to test for infection confirmed the presence of staphylococcus aureus, however was negative for methicillin-resistant staphylococcus aureus (mrsa).The patient's right lead was removed due to suspected migration and the patient was prescribed antibiotics to treat the infection.The affected area was examined approximately one week later and their physician noted that the former right lead exit site appeared normal (i.E., non-tender, no drainage, etc.) following completion of a 7-day course of antibiotics (doxycycline).The patient's right lead was replaced following suspected resolution of the initial infection, one week after removal of the original right lead.The patient was provided a 3-day course of prophylactic antibiotics (doxycycline) following the implant procedure in an attempt to limit infection potential.Approximately two weeks after the lead was replaced, the patient reported to the emergency department (ed) for assessment of increased pain at the right lead exit site.The patient additionally reported experiencing swelling, erythema, and foul-smelling purulent discharge from the affected exit site.The patient's leads were removed, and the patient was admitted to the hospital for administration of intravenous (iv) antibiotics and further testing of the issue.The patient received a computed tomography (ct) scan while hospitalized and cultures were performed to test for infection; results of these tests indicated soft tissue cellulitis and the presence of staphylococcus aureus at the right lead exit site.Given that the patient experienced two infections of the same lead exit site within the span of a couple weeks, it is possible that a predisposition to a higher risk of infection and/or foreign body reaction may have caused or exacerbated the reported issue.The patient was transitioned to oral antibiotics (doxycycline and cefadroxil) and discharged from the hospital the day after admission, however no additional updates on resolution of the issue or patient status were available at the time of 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.
Event or Problem Description
The patient experienced an infection of their right lead exit site at two different time points during treatment targeting the occipital nerve.Subject went to ed and was admitted to hospital.Patient's leads were removed and the patient was prescribed 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
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; suite 500; cleveland, OH 44122 ; 2163789067
• MDR Report Key: 21129026
• Report Number: 3011035812-2024-00011
• Device Sequence Number: 7465064
• Product Code: NHI
• UDI-Device Identifier: 00850022775208
• UDI-Public: (01)00850022775208(17)260319(10)78932255
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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: 03/19/2026
• Device Catalogue Number: 9600-9288-6003
• Device Lot Number: 78932255
• 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: 12/12/2024
• Initial Report FDA Received Date: 01/10/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White