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	Inflammation (1932); Sepsis (2067); Skin Inflammation/ Irritation (4545)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the report, the patient presented in clinic for follow-up 19 days after lead placement with slight redness at his right lead exit site and evidence of drainage covering the pad of his tegaderm bandage and slight skin irritation (i.E., redness) around both of the lead exit sites, as well as what appears to be dried surgical glue on the lead away from the exit site.The patient's physician visually assessed the issue and elected to not prescribe antibiotics at that time, and the patient's caretaker was instructed to follow-up if redness or drainage persisted.Approximately three days after being seen in clinic the patient began experiencing significant soreness in his knee and the bandage became saturated with drainage overnight.The patient sought medical attention at an urgent care.The patient was then directed from urgent care to an emergency room, where a physician diagnosed him with sepsis of the knee.A test for mrsa was performed and is currently pending results.The patient was hospitalized, and the following day underwent a surgical debridement procedure for his knee during which the surgeon was unable to locate the patient's leads.A photo attached to the complaint from the date of hospitalization appears to show slight irritation (i.E., redness) surrounding both of the lead exit sites.Per follow-up with a representative in contact with the patient, the patient removed their leads themself the night before their debridement procedure.The patient has been receiving antibiotic treatment for the issue.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The complaint reports that the patient presented in clinic for follow-up 19 days after lead placement with slight redness at his right lead exit site and evidence of drainage covering the pad of his tegaderm bandage.The patient's bandage was changed in clinic.A photo attached to the complaint from this appointment appears to show slight skin irritation (i.E., redness) around both of the lead exit sites, as well as what appears to be dried surgical glue on the lead away from the exit site.A photo of the bandage that was reportedly placed by the patient's caregiver (i.E., spouse) was also taken at this appointment and appears to show saturation of approximately two thirds of the tegaderm bandage's pad; it additionally appears as though at least one of the lead exit sites, as well as portions of both leads were covered by the adhesive portion of the bandage.The patient's physician visually assessed the issue and elected to not prescribe antibiotics, and the patient's caretaker was instructed to follow-up if redness or drainage persisted.Approximately three days after being seen in clinic the patient began experiencing significant soreness in his knee and the bandage became saturated with drainage overnight.The patient was unable to contact his physician due to it being a weekend and sought medical attention at an urgent care.The patient was then directed from urgent care to an emergency room, where a physician diagnosed him with sepsis of the knee.A test for mrsa was performed and is currently pending results.The patient was hospitalized, and the following day underwent a surgical debridement procedure for his knee during which the surgeon was unable to locate the patient's leads.A photo attached to the complaint from the date of hospitalization appears to show slight irritation (i.E., redness) surrounding both of the lead exit sites.Per follow-up with a representative in contact with the patient, the patient removed his leads himself the night before his debridement procedure.The patient's caretaker kept the explanted leads and will be providing them to an spr representative.A photo attached to the complaint of the explanted leads appears to show that the leads were removed intact.The patient has been receiving antibiotic treatment for the issue.The sprint patient instructions for use instruct to "not let the adhesive portion of the bandage touch the microlead exit site".It is possible that inadequate maintenance of system components (i.E., the bandage), the patient's medical history unrelated to sprint, and/or predisposition for increased sensitivity to foreign body reaction may have caused or exacerbated the reported issue.Note that the patient's spouse was reportedly unable to identify any factors that may have predisposed that patient to a higher risk of infection.The patient's implanting physician reportedly does not believe the patient's condition was caused by sprint; further information regarding the physician's opinion on the cause of the issue was not available at the time of investigation.Per follow-up with a representative in contact with the patient, the patient's condition is improving, and he is anticipated to be discharged approximately four days after being hospitalized for the issue.

• 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
• MDR Report Key: 16477465
• Report Number: 3011035812-2023-00002
• Device Sequence Number: 15333784
• Product Code: NHI
• UDI-Device Identifier: 00854001007557
• UDI-Public: (01)00854001007557(17)231101(10)M1019102022
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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: 11/01/2023
• Device Model Number: 9600-9288
• Device Catalogue Number: 9288-6002
• Device Lot Number: M1019102022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• 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; Hospitalization; Required Intervention
• Patient Sex: Male