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	Erythema (1840); Unspecified Infection (1930)
Date of Event	08/31/2023
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 a suspected infection at their lead exit site.Photos appear to show a tissue reaction concentrated beneath and around the mounting cradle that extended across the lead exit site; this includes notable areas of erythematous and/or broken skin covered in what may be wound exudate (e.G., purulent discharge).The patient was reportedly prescribed two rounds of antibiotics for treatment of the issue.The patient's physician reportedly elected to remove the lead prior to the planned end of treatment date due to this issue.Note that there was no report of a culture to confirm the suspected infection.Given the pattern of the tissue reaction seen in the photos, it is possible that the issue reported in this complaint may have been caused or exacerbated by an increased sensitivity to adhesive system components (e.G., mounting cradles, bandages).It is a known risk that a patient may develop an infection during use of the sprint pns system that requires medical intervention or prescribed medication to treat.Given that the issue was reported to be resolving well, per an update provided by a representative in contact with the patient, no lasting effects are anticipated.
Event or Problem Description
Patient has suspected infection.

• Brand Name: SPRINT
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd.; ste. 500; cleveland OH
• Manufacturer (Section G): SPR THERAPEUTICS; 22901 millcreek blvd.; ste. 500; cleveland OH
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; ste. 500; cleveland, OH
• MDR Report Key: 17868551
• Report Number: 3011035812-2023-00019
• Device Sequence Number: 20590281
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)240601(10)M1103042023
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/04/2023

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: 06/01/2024
• Device Model Number: 9600-9288
• Device Lot Number: M1103042023
• 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: 09/05/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female