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

Model Number	Endura, Sales Configuration
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Presyncope (4410)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The lead was placed without difficulty and then the patient experienced a vasovagal episode during the subsequent testing of the lead.The patient then developed bradycardia and low blood pressure.The doctor administered glycopyrrolate 0.1 mg and ephedrine 10 mg intravenously which stabilized both the patient's heart rate and blood pressure to her normal values.The patient was in verbal communication with the investigator throughout and never lost consciousness.The patient stated that she frequently has these vasovagal episodes and this experience was the same as previous episodes.
Additional Manufacturer Narrative
The study participant experienced low heart rate (i.E., bradycardia) and low blood pressure (i.E., hypotension).These vitals stabilized to normal levels following the physician's administration of ephedrine and glycopyrrolate.The subject remained conscious and verbally communicative.The vasovagal episode was most likely related to study participation, but the event was reportedly specific to this subject's pre-existing propensity towards vasovagal episodes.It is not suspected that the sprint product was faulty or had any specific deficiency based on the information available in this report.The subject's leads were removed and they withdrew from the study, but reportedly underwent their planned surgical procedure without incident and was discharged home within two hours of surgery, as expected.No lasting adverse effects are anticipated, given that the issue reportedly resolved, and the subject completed their ambulatory surgery as expected.

• Brand Name: SPRINT PNS SYSTEM
• 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 OH 44122
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; ste 500; cleveland, OH 44122 ; 2163789067
• MDR Report Key: 16539328
• Report Number: 3011035812-2023-00003
• Device Sequence Number: 20332595
• Product Code: NHI
• UDI-Device Identifier: 00854001007540
• UDI-Public: (01)00854001007540(17)231206(01)M1053102022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2023

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: 12/06/2023
• Device Model Number: Endura, Sales Configuration
• Device Catalogue Number: 9244-6001
• Device Lot Number: M1053102022
• 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: 02/18/2023
• Initial Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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: Other
• Patient Sex: Female