MAUDE Adverse Event Report: SPR THERAPEUTICS SPRINT PNS SYSTEM; 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); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	06/04/2023
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 experienced drainage from their lead exit sites beginning 3 days after lead placement.The patient reportedly also experienced skin irritation (i.E., redness) and pain at the lead exit sites.Photos attached to the complaint taken within the first 10 days of treatment appear to show skin irritation (i.E., redness) surrounding the lead exit sites, as well as what may be dried blood and/or surgical glue at the exit site.Per the complaint report, the patient's spouse applied triple antibiotic cream, antifungal cream, and cavilon barrier film to the lead exit site in an attempt to treat the issues.The issues reportedly appeared to be resolving after the patient's spouse was advised to discontinue application of creams to the lead exit site, despite the onset of swelling in the affected area at the same time.The day after the patient reported the issues to be resolving the patient was reportedly prescribed antibiotics for treatment of the issues; however, they were not seen in office for evaluation of the issue and the physician's direct assessment of the issue at the time of antibiotic prescription is unknown.Approximately 2 weeks later, the patient reportedly elected to remove the leads himself due to concern of infection, pain, and swelling of the affected.Approximately 3 days after the leads were removed the patient was still experiencing swelling of the area and went to the emergency room (er) for further evaluation.The patient was later seen by their primary care physician for a follow-up appointment and was prescribed another round of antibiotics for treatment of the issue.Approximately 2 weeks later, the patient returned to the er due to continued swelling, pain, and redness of the area.An x-ray performed at the er reportedly did not show evidence of a lead remnant.The patient was reportedly diagnosed with an infection in their leg and hospitalized for the following 4 days.While hospitalized, the patient was reportedly administered intravenous antibiotics and underwent irrigation and drainage procedures to reduce swelling.A culture was reportedly performed to confirm the suspected infection; however, the discrete results of the culture were not available at the time of this investigation.If additional information regarding the results of the culture become available, this investigation will be updated.The patient was reportedly discharged from the hospital with additional antibiotics and pain medication for further treatment of the issue.Per follow-up with a representative in contact with the patient, the patient reportedly has a history of medical issues and interventions prior to being implanted with sprint, including bone trauma (i.E., fracture), staphylococcus infection, and coronary artery bypass surgery.Although additional information about these pre-existing conditions and their potential relevance to the issue was not available at the time of investigation, it is possible that the patient's medical history unrelated to sprint may have contributed to the patient being at a higher risk of infection.Additionally, the patient's spouse reported believing the swelling reported in this complaint could have been related to the patient's lack of compliance with a prescribed medication regiment, per follow-up with a representative in contact with the patient.While the name and type of the medication the spouse was referring to is unknown, it is possible that noncompliance with an established treatment regiment could have influenced the severity of the issues reported in this complaint.No additional information regarding resolution of this issue was available.If additional information regarding resolution of the issue becomes available, this investigation will be updated.
Event or Problem Description
On (b)(6), the patient stated their lead exit site was red and had clear liquid drainage.They applied triple antibiotic cream, antifungal cream, and then described using cavilon wipes on the lead exit site as well.They were informed that is not the intended use of the cavilon wipes and that they should follow-up with the physician.The patient was prescribed antibiotics.Then around (b)(6) the patient started to experience swelling in their calf and pulled the leads out themselves.They went to the emergency room on (b)(6) for the swelling and a few days later the patient's pcp started them on another antibiotic.They returned to the emergency room on (b)(6) for swelling, redness, pain, and concerns of a blood clot.X-rays determined there was no lead remanent.They were hospitalized from (b)(6), they received iv antibiotics, and they did "irrigation procedures" to drain the leg.They did a culture, and they were put on a different antibiotic.They will be on antibiotics for the next 6 weeks via a pic line.

• Brand Name: SPRINT PNS SYSTEM
• 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 ; 2163789067
• MDR Report Key: 17482368
• Report Number: 3011035812-2023-00014
• Device Sequence Number: 7037821
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)240421(10)68424304
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/08/2023

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: 04/21/2024
• Device Model Number: 9600-9288
• Device Lot Number: 68424304
• 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: 07/26/2023
• Initial Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• 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; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male