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); Fluid Discharge (2686); Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Date of Event	10/21/2023
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 soreness in the muscle beneath their lead exit sites, as well as tenderness and swelling.The patient presented in-clinic the following day with serosanguinous drainage on their bandage and erythema around the lead exit site.A photo was provided and appears to show redness at the exit site, as well as faint redness approximating the shape of a waterproof bandage.The patient's physician diagnosed the patient with an infection and elected to remove the leads prior to the planned end of treatment date.There was no report of a culture to confirm the suspected infection.The patient was prescribed antibiotics (bactrim) for treatment of the issue.The patient reported experiencing itching beneath the bandage prior to the onset of the issue reported in this complaint.Given the previous report of itching beneath the bandage and the shape of redness in the photo attached to this complaint, it is possible that sensitivity to adhesive system components (e.G., the bandage) may have caused or exacerbated the issue reported in this complaint.The issue reportedly resolved with no lasting effects, per an update provided by a representative in contact with the patient.
Event or Problem Description
The patient experienced soreness in the muscle beneath their lead exit sites, as well as tenderness and swelling.The patient presented in-clinic the following day with serosanguinous drainage on their bandage and erythema around the lead exit site.Additionally, the patient reported that they had a fever of 100.4 the previous night.The patient was diagnosed with an infection, prescribed antibiotics, and their leads were removed prior to the planned end of treatment date.

• 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: 18181069
• Report Number: 3011035812-2023-00021
• Device Sequence Number: 20735791
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)240801(10)M1062042023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/21/2023

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: 08/01/2024
• Device Model Number: 9600-9288
• Device Lot Number: M1062042023
• 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: 10/22/2023
• Initial Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2023
• 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: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female