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	Unspecified Infection (1930); Ambulation or Postural Difficulties (2544)
Date of Event	12/19/2023
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 initially experienced redness at their lead exit sites, as well as stiffness and pain in their knee during stimulation treatment targeting the genicular nerve(s).The patient was seen in-clinic by a physician and the physician elected to remove the leads prior to the planned end of treatment date due to suspected infection.The patient was prescribed antibiotics for treatment of the issue and instructed to return for a follow-up evaluation a few weeks after being seen in clinic.The patient reportedly went to the emergency room (er) due to this issue following the initial in-clinic assessment and scans completed at the er showed that the infection had affected their artificial knee joint.Per the complaint report, it is possible that a culture was performed to further characterize the reported infection; however, it is unclear from the information available if a culture was performed and what results, if any, were obtained.The patient underwent surgical removal of their entire artificial knee joint, as well as removal of the surrounding infected tissue and accumulated pus.The patient was prescribed 6 weeks of intravenous (iv) antibiotics and anticipated that they may receive a knee joint replacement if the affected knee remains free of infection following the cessation of iv antibiotics.Given the target location for the patient's leads, it is possible that infection at the lead exit site(s) may have caused or contributed to the issue.It is unclear from the information available what the suspected source(s) of infection was; possible causes and/or contributing factors could include insufficient care of the lead exit site, predisposition for increased sensitivity to foreign body reaction, history of infection prior to being implanted with sprint, or for reasons unrelated to use of the sprint system (e.G., medication side effects).Per the complaint report, the patient experienced a skin reaction to the waterproof bandage.Therefore, it is also possible that sensitivity to adhesive system components (e.G., the waterproof bandage) may have caused or exacerbated the reported issue.No additional information regarding resolution of the reported issue was available at the time of investigation.If additional information becomes available regarding resolution of the issue, this investigation will be updated.
Event or Problem Description
Patient's knee became infected during treatment with the sprint pns system.The leads were removed and the patient was prescribed antibiotics.Patient was hospitalized a week later and his artificial knee joint was removed because of the infection.

• Brand Name: SPRINT
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd.; suite 500; cleveland OH
• Manufacturer (Section G): SPR THERAPEUTICS; 22901 millcreek blvd.; suite 500; cleveland OH
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; suite 500; cleveland, OH
• MDR Report Key: 18510595
• Report Number: 3011035812-2024-00001
• Device Sequence Number: 15217875
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)240907(10)71870629
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 01/15/2024

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: 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: 12/20/2023
• Initial Report FDA Received Date: 01/15/2024
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male