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

Model Number	9600-9288
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Confusion/ Disorientation (2553); Skin Inflammation/ Irritation (4545)
Date of Event	11/07/2023
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 was hospitalized for 5 days during treatment with sprint.Per follow-up with a representative in contact with the patient, the patient experienced chills, a fever, disorientation, and tenderness at their lead exit site leading up to the hospitalization.The treating physician reportedly noted redness at the lead exit sites upon examination and suspected the patient had a methicillin-resistant staphylococcus aureus (mrsa) infection.A pet scan and lab work were reportedly performed at the hospital to further characterize the issue; however, the results of these tests were not available at the time of investigation.The patient reportedly received intravenous (iv) antibiotics while admitted and was prescribed oral antibiotics following being discharged from the hospital.It is unclear from the information available whether the patient may have a previous medical history (e.G., history of mrsa) and/or other risk factors that increased the likelihood of experiencing an infection during stimulation treatment.The issue reportedly resolved with no lasting effects and the patient was reportedly able to continue receiving stimulation treatment following discharge from the hospital.
Event or Problem Description
Patient checked into the hospital with a fever of 102.5, chills to the point of shaking, disorientation, and tenderness at the sprint lead exit sites in his back.The examining physician reportedly noted redness in the area of the lead exit sites and suspected mrsa.The patient was administered iv antibiotics while admitted and oral antibiotics for use after discharge.He was discharged from the hospital after 5 days and was not able to verify that using the sprint device is what caused his adverse events.

• Brand Name: SPRINT
• 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: 18318665
• Report Number: 3011035812-2023-00022
• Device Sequence Number: 7391848
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)240907(10)71870629
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K223306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 12/13/2023

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: 09/07/2024
• Device Model Number: 9600-9288
• Device Lot Number: 71870629
• 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: 11/13/2023
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• 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: Required Intervention; Other; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male