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	Purulent Discharge (1812); Erythema (1840); Skin Infection (4544)
Date of Event	04/12/2023
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 states that the patient reported pus, redness, and pain at the lead exit site during a bandage change.A photo was provided showing severe redness (erythema) and areas of raised skin (bumps) that appear to have formed a rash surrounding one of the lead exit sites, approximating the shape of the non-adhesive portion of the bandage that would have been placed on top of it.The photo additionally shows a darker area of discoloration surrounding the lead exit site, which may be attributed to the hardened surgical glue which the patient's physician reportedly liberally applied.The patient went to urgent care for examination of the issue, where a nurse reportedly suspected that the issue was the result of an infection.Note that there was no report of a culture to test for infection.The patient was reportedly prescribed antibiotics at the time of the urgent care visit for treatment of the issue.Due to the proximity of the suspectied infection to hardware from previous arthroplasties, this event is considered a serious inury as an infection in this location had the potential to require hardware removal.In the photo of the lead exit site there is a break in the pattern of redness near the cable of the microlead connector, which suggests that the bandage may not have been adhered well there.Therefore, although the patient reportedly did not believe that there was water under the bandage, it is possible than an inadequate seal against the skin allowed water to leak beneath the bandage.Given this pattern of irritation, and reports that a few different people performed bandage changes for the patient (i.E., her nurse, her daughter, and her granddaughter), it is possible that improper maintenance of the bandage may have caused or exacerbated the issue reported in this complaint.It is also possible that skin irritation from adhesive system components (e.G., the bandage) may have caused or exacerbated the issue reported in this complaint, however this possibility is less likely given that the issue was only reported to occur at one of the patient's two lead exit sites.The issue reportedly resolved with no lasting effects, per follow-up with a representative in contact with the patient.
Event or Problem Description
The patient reported pus, redness, and pain at the lead exit site during a bandage change.A photo was provided showing severe redness (erythema) and areas of raised skin (bumps) that appear to have formed a rash surrounding one of the lead exit sites, approximating the shape of the non-adhesive portion of the bandage that would have been placed on top of it.The photo additionally shows a darker area of discoloration surrounding the lead exit site, which may be attributed to the hardened surgical glue which the patient's physician reportedly liberally applied.The patient went to urgent care for examination of the issue, where a nurse reportedly suspected that the issue was the result of an infection.Note that there was no report of a culture to test for infection.The patient was reportedly prescribed antibiotics at the time of the urgent care visit for treatment of 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 ; 2163789067
• MDR Report Key: 17023549
• Report Number: 3011035812-2023-00009
• Device Sequence Number: 12506400
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)240415(10)M1076102022
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/30/2023

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: 04/15/2024
• Device Model Number: 9600-9288
• Device Catalogue Number: 9600-9288
• Device Lot Number: M1076102022
• 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: 04/12/2023
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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; Required Intervention
• Patient Sex: Female