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

Model Number	9600-9244-60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The complaint reports that the patient experienced pain and soreness at the exit site for their lead targeting the left l3 medial branch of the dorsal ramus.A photo attached to the complaint appears to show an area of raised skin (i.E., a bump) at the lead exit site, as well as areas of skin discoloration (e.G., redness) at the exit site and on the left side of the patient's back that may have overlapped with the areas that were presumably covered by the patient's waterproof bandage(s).Per the complaint report and follow-up with a representative in contact with the patient's physician's office, the patient went to the local emergency room (er) for assessment of the issue and was subsequently hospitalized for approximately 3 days due to infection of the affected lead.The patient's implanting physician reportedly elected to remove the affected lead on the second day of the patient's hospitalization and noted purulent discharge (i.E., pus) on the lead during removal.Blood cultures performed to test for infection were reportedly negative, and the patient did not experience a fever or elevation in white blood cell count in association with this issue.While hospitalized, the patient reportedly received intravenous antibiotics and was prescribed oral antibiotics for further treatment of the issue.Prior to receiving their lead that targeted the left l3 medial branch of the dorsal ramus, the patient underwent lead placement targeting the left sciatic nerve and the patient reported drainage from their sciatic lead exit site prior to placement of the lumbar lead.Although there was no other report of irritation or infection at the patient's sciatic lead, the occurrence of discharge at each of the patient's lead exit sites suggests it is possible that a predisposition or increased sensitivity to foreign body reaction may have caused or exacerbated the issue reported in this complaint.Given that the issue was reportedly resolving with the use of oral antibiotics and the patient reported pain subsiding 4 days after the issue began no lasting adverse effects are anticipated.
Event or Problem Description
The patient reportedly experienced pain and soreness at the exit site for their lead targeting the left l3 medial branch of the dorsal ramus.The patient went to the local emergency room (er) for assessment of the issue and was subsequently hospitalized for approximately 3 days due to infection of the affected lead.The patient's implanting physician reportedly elected to remove the affected lead on the second day of the patient's hospitalization and noted purulent discharge (i.E., pus) on the lead during removal.While hospitalized, the patient reportedly received intravenous antibiotics and was prescribed oral antibiotics for further treatment of the issue.

• Brand Name: SPRINT
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd.; ste. 500; cleveland
• 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
• MDR Report Key: 17408294
• Report Number: 3011035812-2023-00012
• Device Sequence Number: 17601647
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)240225(10)68424290
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K223306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/27/2023

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: 02/25/2024
• Device Model Number: 9600-9244-60
• Device Lot Number: 68424290
• 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: 07/07/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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; Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female