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 Code	Convulsion/Seizure (4406)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prior to the lead placement procedure, the patient's physician was reportedly unaware that the patient had a previous history of experiencing seizures when having medical procedures.Per follow-up with a representative in contact with the patient, an attempt was later made to utilize the system, but patient's physician reportedly advised that the lead be pulled after the patient experienced another seizure.It is unclear from the information available whether the patient's seizures were epileptic in nature.Epilepsy is characterized by seizures that are recurrent and unprovoked, and its causes may be idiopathic or symptomatic of other brain disorders (e.G., malformations, strokes, tumors).Seizures may also be nonepileptic (potentially psychogenic) in origin or may be provoked by a temporary disorder or stressor (e.G., metabolic disorders, central nervous system [cns] infections, cardiovascular disorders, drug toxicity or withdrawal, psychiatric disorders).Nonepileptic events such as convulsive syncope may also present with similar symptoms as epilepsy (e.G., head/eye deviations, automatisms and dystonic movements), and therefore may not be easy to differentiate from seizures.The sprint peripheral nerve stimulation (pns) system is contraindicated for patients who have epilepsy, if the leads are intended to be placed in the head or neck; stimulation of non-indicated targets may generate unwanted systemic/autonomic response requiring medical treatment and possibly hospitalization, such as seizure.However, such effects are typically not expected to be caused by stimulation of the lumbar medial branches of the dorsal ramus, which were reportedly targeted during this patient's lead placement procedure.Given that the documented lead placement target was at the level of the l4 spinal segment, and the report that stimulation was only administered during the lead placement procedure, it is unlikely that stimulation caused the issue described in this complaint.Per correspondence with a medical advisor, the issue appeared to be presentation of a pre-existing condition that was temporally correlated with the implant procedure, and it is uncertain that the procedure was causative.Since the patient's equipment has not been returned, inspection of the device is not feasible.It is not suspected that the sprint product was faulty or had any specific deficiency based on the information available in this report.
Event or Problem Description
During post-procedure patient education, the patient stated her head felt funny and she became very pale.The clinic staff transferred her to a stretcher (lying flat) and she had multiple seizures before being transferred via ems to the hospital.Patient's seizures correlated with positional changes (i.E., sitting up, transfer from stretcher to stretcher).The patient was sedated via ems prior to leaving the clinic.Stimulation was only administered during testing in the lead placement procedure and there were no issues intraoperatively.Stimulation was never turned on in recovery and the external pulse generator was removed from her body prior to transfer.The patient's daughter reported that the patient has had seizures previously when having procedures at the hospital.The patient was discharged that same evening and had another seizure the next morning.

• 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: 16590497
• Report Number: 3011035812-2023-00005
• Device Sequence Number: 2907010
• Product Code: NHI
• UDI-Device Identifier: 00854001007540
• UDI-Public: (01)00854001007540(17)231101(10)M1114082022
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K223306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/22/2023

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: 11/01/2023
• Device Model Number: Endura, Sales Configuration
• Device Catalogue Number: 9244-6001
• Device Lot Number: M1114082022
• 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: 02/28/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female