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

Catalog Number	9600-9288
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Fluid Discharge (2686); Blister (4537)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's leads were removed due to suspected infection at medial lead.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.It was reported that both of the patient's leads were removed prior to the planned end of treatment date due to a suspected infection at the medial lead.The patient experienced a nickel-sized blister at the medial lead exit site accompanied by yellow-tinted drainage from the site in association with this issue.There was no report of a culture to test for infection.The patient was reportedly prescribed antibiotics for treatment of the issue, per a representative in contact with the patient.The suspected infection reportedly resolved, per an update provided by a representative in contact with the patient.An approximately quarter-sized area of redness reportedly remains around the exit site, however.

• Brand Name: SPRINT
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd.; suite 500; cleveland OH 44122
• Manufacturer (Section G): SPR THERAPEUTICS; 22901 millcreek blvd.; suite 500; cleveland OH 44122
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; suite 500; cleveland, OH 44122 ; 2163789067
• MDR Report Key: 19347825
• Report Number: 3011035812-2024-00003
• Device Sequence Number: 11405197
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)241110(10)M1007072023
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K223306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/17/2024

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: 11/10/2024
• Device Catalogue Number: 9600-9288
• Device Lot Number: M1007072023
• 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: 04/17/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2023
• 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: 76 YR
• Patient Sex: Unknown