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

Model Number	Extensa, Sales Configuration
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Skin Infection (4544)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record was performed, and no anomalies were found.Per follow-up with a representative in contact with the patient, the patient experienced pain at the lead exit sites, a large red bump, and purulent discharge (i.E., pus) from the exit sites upon removal of the leads.The patient was reportedly diagnosed with a staphylococcus infection by a physician.The patient was reportedly treated with intravenous antibiotics at the emergency room, as well as with oral antibiotics for an additional 5 days, and the infection has resolved.Prior to removal, the lead remained indwelling for 129 days.The sprint system is indicated for up to 60 days of use and the risk of infection from use of percutaneous lead(s) with the sprint system for longer than the indicated length of time has not been studied.Use of the system for longer than 60 days is contraindicated.
Event or Problem Description
Patient had an infection at the time of lead explant on (b)(6) 2023.The device was implanted for much longer than the 60 days indicated in the instructions for use.The doctor prescribed antibiotics and mri imaging.The patient was diagnosed with a staph infection.The mri showed the infection did not reach spinal cord, but showed inflammation of hips, bottom, and legs.

• Brand Name: SPRINT PNS SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd.; ste 500; cleveland OH 44122
• Manufacturer (Section G): SPR THERAPEUTICS; 22901 millcreek blvd.; ste 500; cleveland OH 44122
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; ste 500; cleveland, OH 44122 ; 2163789067
• MDR Report Key: 16724370
• Report Number: 3011035812-2023-00008
• Device Sequence Number: 7226282
• Product Code: NHI
• UDI-Device Identifier: 00854001007557
• UDI-Public: (01)00854001007557(17)231101(10)M1039082022
• 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: 2022
• Device Explanted Year: 2023
• 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): 04/12/2023

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: 11/01/2023
• Device Model Number: Extensa, Sales Configuration
• Device Catalogue Number: 9288-6002
• Device Lot Number: M1039082022
• 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: 03/16/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2022
• 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: Other; Required Intervention
• Patient Sex: Female