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

Catalog Number	9600-9244-60
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's lead fractured upon explant.Patient was referred to a surgeon for removal of the remnant as he reported pain at the location of the remnant.Antibiotics were prescribed as a precaution.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The patient experienced severe pain at their lead exit site after beginning physical therapy following removal of the lead.The pain was reportedly noted in response to touch and movement of their leg, impacting the patient's ability to walk.The lead was fractured upon removal and a remnant remained flush with the skin; the patient's physician reportedly believed the patient's pain was associated with the lead remnant.Imaging of the lead exit site (x-ray) was performed, and the lead remnant was noted as appearing to be lodged within muscle.Antibiotics were prescribed as a precaution; however, no additional signs of infection were reported.The patient was referred to another provider for surgical removal of the lead remnant, however it is not clear from the information available whether the removal procedure had been performed by the time of this investigation.No additional information regarding resolution of the issue was available at the time of investigation.If additional information becomes available regarding resolution, this investigation will be updated.

• 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: 21400849
• Report Number: 3011035812-2025-00003
• Device Sequence Number: 18470989
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)250708(10)M1025042024
• 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: 2024
• Device Explanted Year: 2025
• 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): 02/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2025
• Device Catalogue Number: 9600-9244-60
• Device Lot Number: M1025042024
• 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: 01/20/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 34 YR
• Patient Sex: Male