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	Pain (1994); Ambulation or Postural Difficulties (2544); Fluid Discharge (2686)
Date of Event	05/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The patient experienced excessive fluid build up in the area of their medial genicular lead.The patient's lead was reportedly observed to piston approximately a half of an inch both in and out of the skin.The patient's physician reportedly elected to remove the medial lead eleven days after placement due to concern that lead movement relative to the skin would allow for ingress of pathogens from the externalized portion of the lead to the subcutaneous tissue and lead to an infection.The remaining lead was removed eleven days later due to recurrence of fluid build up and increased pain preventing the patient from walking.Fluid was aspirated from the patient's knee on three separate occasions in association with this issue, including at the time of each lead's removal.Magnetic resonance imaging (mri) was performed to further characterize the issue; however, the results of this testing were not available at the time of investigation.The patient was prescribed oral antibiotics for treatment of this issue.The patient has a prior history of fluid build up in the affected knee and a history of surgery in the region impacted by this complaint issue (i.E., a partial knee replacement).Therefore, it is possible that the issue reported in this complaint may have been caused or exacerbated by the patient's medical and surgical history unrelated to sprint (e.G., through an increased risk of lymphedema if damage from prior surgery impaired lymphatic drainage).It is not suspected that the sprint product was faulty or had any specific deficiency based on the information available in this report.Per an update provided by a representative in contact with the patient, the patient was reportedly being seen by a new physician (i.E., not the implanting physician) for treatment of the issue and removal of their surgical hardware was being considered.No additional information regarding resolution of the issue or completion of further interventions was available at the time of investigation.If additional information becomes available, this investigation will be updated.
Event or Problem Description
Patient experienced excessive fluid build up in the area of their medial genicular lead.The patient's leads were removed due to infection concerns and pain resulting in difficulty walking.Fluid was aspirated from the patient's knee on three separate occasions in association with this issue, including at the time of each lead's removal.

• 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: 19532228
• Report Number: 3011035812-2024-00006
• Device Sequence Number: 7681082
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)250202(10)72367432
• 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: 2024
• Device Explanted Year: 2024
• 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): 06/13/2024

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: 02/02/2025
• Device Model Number: 9600-9288
• Device Lot Number: 72367432
• 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: 05/17/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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
• Patient Age: 56 YR
• Patient Sex: Female