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	Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Ambulation or Postural Difficulties (2544); Skin Inflammation/ Irritation (4545)
Date of Event	02/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced an infection near her lead exit site.Patient's lead was removed in the ed and antibiotics were prescribed.The site was lanced, drained, and packed.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The patient experienced an infection at their lead exit site during treatment.The issue began with significant soreness near the lead exit site accompanied by a moderate amount of yellow-tinted drainage on their bandage; this soreness reportedly worsened to the point of causing difficulty with walking within two days of the issue's onset.The patient also had redness, scabbing, and swelling around the exit site in the area where the adhesive portion of the bandage would have been placed.The patient consulted their implanting physician regarding the issue and removal of the lead was advised.Given that the patient was out of town at the time of the issue, they reported to an emergency department (ed) for further assessment of the issue.The patient's lead was removed at the ed and antibiotics were prescribed for treatment of the issue.Blood tests were performed to further characterize the issue; however, results of these tests were not available at the time of this investigation.The patient reported a return of soreness surrounding the former lead exit site four days after leaving the ed and was seen by a pain physician for additional assessment of the area.Significant purulent drainage was noted at the site and with expression.The exit site was lanced, drained, and packed to treat the issue.The patient reported an improvement of pain and soreness as of two days after the incision and drainage procedure.No additional information regarding complete resolution of the issue was available at the time of this 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.

• 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 ; 2163789067
• MDR Report Key: 21662170
• Report Number: 3011035812-2025-00004
• Device Sequence Number: 15637811
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)251121(10)76914219
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 03/21/2025

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: 11/21/2025
• Device Catalogue Number: 9600-9244-60
• Device Lot Number: 76914219
• 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: 02/24/2025
• Initial Report FDA Received Date: 03/21/2025
• 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 Age: 58 YR
• Patient Sex: Female