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

Catalog Number	9600-9288
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	12/05/2025
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 collapsed lung (i.E., pneumothorax) following removal of their leads targeting thoracic intercostal nerves.Per the patient's report, the issue occurred during a lead remnant removal procedure following a lead fracture during the initial explant attempt.The patient claimed that the physician went through their ribs to administer an anesthetic and the needle pierced their lung.The patient reported that the physician used fluoroscopy to visualize the remnant but did not use imaging while administering the anesthetic.Per the physician's report, "a lot of resistance" was felt during lead explant, and one of the leads ultimately fractured.Administration of an anesthetic prior to attempted lead removal was not mentioned in the physician's report.Fluoroscopy was reportedly utilized to visualize the remnant, however contrary to the patient's report the physician states there was no attempt to remove the retained lead fragment.The patient reportedly began to feel unwell while at the physician's office and was referred to the emergency room (er); no additional information regarding specific symptoms the patient experienced was available at the time of investigation.Evaluation at the er and hospital reportedly revealed that the patient had a small pneumothorax.The physician reported having no knowledge of what ultimately caused the pneumothorax.Per the physician's report, no chest tube was required for treatment of the issue, however the patient was admitted to the hospital for observation.Per the patient, they remained in the intensive care unit (icu) for a total of 4 days due to this issue due to the conflicting and incomplete reports regarding the issue and the circumstances surrounding its onset, the underlying cause of the issue is unclear.No additional information about interpretation of the x-ray images (e.G., location(s) of the patient's leads or the retained fragment), or details related to the original lead placement approach were available for complaint investigation.However, given that the patient's leads were placed targeting thoracic intercostal nerves, which are in close proximity to the thoracic pleura, and the patient's symptoms starting soon after lead removal, it is possible that the issues reported in this complaint may have been caused by contact between the lead or procedural preparation tools (i.E., anesthetic needles) with the pleural cavity during the lead explant procedure.Given that the patient reported resolution of the issue at the time of complaint submission, no lasting adverse effects are anticipated and no further investigation is required.
Event or Problem Description
Patient's lead fractured during explant on (b)(6) 2025.Patient reported that their lung collapsed while the physician tried to remove the lead remnant.They reported that the physician tried to go through their rib to numb the area and pierced their lung.He did an x-ray to locate the remnant but did not use any imagining while numbing the area.Patient was rushed to icu and stayed for 4 days.Patient is recovered now.

• 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: 23935063
• Report Number: 3011035812-2025-00012
• Device Sequence Number: 9611276
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)260905(10)83985304
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K223306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/31/2025

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: 09/05/2026
• Device Catalogue Number: 9600-9288
• Device Lot Number: 83985304
• 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: 12/05/2025
• Initial Report FDA Received Date: 12/31/2025
• 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: Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female