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	Abscess (1690); Purulent Discharge (1812); Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)
Date of Event	05/07/2025
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 soreness and purulent discharge (i.E., pus) at their lead exit site.A photo was provided and appears to show an area of raised and discolored skin around the lead exit site in addition to what may be a small pustule.The patient was seen by their physician two days after original report of this issue for removal of their lead; the physician noted that the patient appeared "incredibly ill" at this appointment.In addition to removal of the lead, an incision and drainage procedure was performed at the time of lead removal to address the purulent discharge present at the site.Note that there was no report of a culture performed to further characterize the issue.The patient was prescribed oral antibiotics for further treatment.The issue was reported to be improving following removal of the lead and prescription of antibiotics, per an update provided by a representative in contact with the patient.Therefore, no lasting adverse effects are anticipated.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 soreness and purulent discharge at their lead exit site.The patient's lead was removed and an incision and drainage procedure was performed to address the purulent discharge present at the site.Patient was prescribed 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: 22144381
• Report Number: 3011035812-2025-00007
• Device Sequence Number: 7487357
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)260102(10)80112301
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/04/2025

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: 01/02/2026
• Device Catalogue Number: 9600-9244-60
• Device Lot Number: 80112301
• 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: 05/07/2025
• Initial Report FDA Received Date: 06/04/2025
• 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
• Patient Sex: Unknown