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

Catalog Number	9600-9288-6003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Fluid Discharge (2686)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced an infection in their knee and was hospitalized for wound debridement.Lead was removed and patient was prescribed iv and oral antibiotics.Patient since discharged and feeling better.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.01 may 2025 per complaint record, patient seen by physician for possible infection.Patient experiencing pain and stiffness, skin is red and drainage present.Md removed leads and performed ultrasound of the knee which revealed fluid buildup.Md aspirated knee, total of 80ml of yellow fluid was drained.Md collected sample to be sent off to path lab for culture.Keflex 500mg q6 hours prescribed.Total days of therapy 56 days.Patient has a history of right knee pain and osteoarthritis.Updates provided 09 may 2025 and 13 may 2025 reported orthopeadic physicians felt the patient may have a pseudo gout that trapped the bacteria.Culture confirmed infection, type of bacteria unknown.Patient was hospitalized for wound debridement, picc line insertion for iv antibiotics and then oral amoxicillin for 1 week.Patient discharged home and reported feeling better.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
• MDR Report Key: 22109124
• Report Number: 3011035812-2025-00006
• Device Sequence Number: 8140619
• Product Code: NHI
• UDI-Device Identifier: 00850022775208
• UDI-Public: (01)00850022775208(17)260402(10)502760
• 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: 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): 05/29/2025

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: 04/02/2026
• Device Catalogue Number: 9600-9288-6003
• Device Lot Number: 502760
• 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: 05/01/2025
• Initial Report FDA Received Date: 05/29/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male