MAUDE Adverse Event Report: SPR THERAPEUTICS SPRINT; PERIPHERAL NERVE STIMULATOR

Model Number	9600-9244-60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Skin Inflammation/ Irritation (4545); Nodule (4551)
Date of Event	03/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient contacted their implanting physician regarding a concern for infection and sent them a photo of the affected area.A photo attached to the complaint appears to show redness surrounding the lead exit site, as well as signs of possible skin irritation extending to the edges of the non-adhesive portion of their bandage.The photo additionally appears to show what may be either discharge or dried surgical glue at the lead exit site and on the lead adjacent to the exit site.The patient reportedly proceeded to the emergency room for evaluation of the issue.The patient's lead was removed on the same day they went to the emergency room.The patient was prescribed two types of antibiotics for treatment of the issue and the issue did not require the patient to be hospitalized, per feedback from representatives in contact with the patient.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The complaint reports that the patient contacted their implanting physician regarding a concern for infection and sent them a photo of the affected area.A photo attached to the complaint appears to show redness surrounding the lead exit site, as well as signs of possible skin irritation extending to the edges of the non-adhesive portion of their bandage.The photo additionally appears to show what may be either discharge or dried surgical glue at the lead exit site and on the lead adjacent to the exit site.The patient proceeded to the emergency room for evaluation of the issue.The patient's lead was removed on the same day they went to the emergency room.A culture performed reportedly grew staphylococcus.The patient was prescribed two types of antibiotics for treatment of the issue and the issue did not require the patient to be hospitalized, per feedback from representatives in contact with the patient.The patient reportedly developed a rash around their lead exit site at least 3 days prior to this complaint being submitted; it is possible that this rash may have caused or contributed to the issue reported in this complaint.Additionally, the patient reported complaints of skin irritation and suspected infection during previous courses of treatment with sprint and reportedly has a history of foreign body reactions to medical implants not related to sprint (e.G., an intrauterine device).It is possible that the patient's previous history of skin irritation/suspected infection, and/or predisposition for increased sensitivity to foreign body reaction, may have caused or exacerbated the reported issue.Per follow-up with a representative in contact with the patient, the patient temporarily experienced purulent discharge (i.E., pus) and redness at the lead exit site following the removal of the lead.Per follow-up received approximately 2 weeks following submission of the complaint, the patient reported experiencing something like a scar and a "lump" at the lead exit site, however the issue was otherwise resolved.

• 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
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; ste 500; cleveland 44122
• MDR Report Key: 16682814
• Report Number: 3011035812-2023-00007
• Device Sequence Number: 7293583
• Product Code: NHI
• UDI-Device Identifier: 00854001007540
• UDI-Public: (01)00854001007540(17)231101(10)M1043102022
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/05/2023

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: 9600-9244-60
• Device Catalogue Number: 9244-6001
• Device Lot Number: M1043102022
• 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: 03/13/2023
• Initial Report FDA Received Date: 04/05/2023
• 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: Required Intervention; Other
• Patient Age: 29 YR
• Patient Sex: Female