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	Abscess (1690); Unspecified Infection (1930); High White Blood Cell Count (4594); Blood Protein Abnormal (4595)
Date of Event	01/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced an infection at their lead exit site along with an abscess.Patient's lead was removed, the abscess was incised, drained, and packed, and both oral and iv antibiotics were prescribed.
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 targeting the suprascapular nerve.The patient's lead was removed at the emergency room (er) thirteen days after initial placement due to the reported infection.The presence of an abscess at the exit site was also reported.The abscess was incised, drained, and packed at the er.Blood tests were performed to characterize the issue and reportedly showed signs of elevated c-reactive protein (crp) and white blood cells (wbc); cultures were performed as well but no information regarding results of the cultures was available at the time of investigation.The patient was administered intravenous (iv) antibiotics and prescribed oral antibiotics for treatment of the issue.Per the report, the patient was taking methotrexate at the time of this issue and was known to be immunocompromised.Therefore, it is possible that the patient's medical history and medication usage unrelated to sprint may have caused or contributed to the reported issue.Per an update provided by a representative in contact with the patient, the issue was resolving.Therefore, no lasting adverse effects are anticipated.

• 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: 21393550
• Report Number: 3011035812-2025-00002
• Device Sequence Number: 12937871
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)250624(10)73870481
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/14/2025

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: 06/24/2025
• Device Catalogue Number: 9600-9244-60
• Device Lot Number: 73870481
• 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: 01/19/2025
• Initial Report FDA Received Date: 02/18/2025
• 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: 76 YR
• Patient Sex: Female