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

Model Number	9600-9288
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint reports that a patient undergoing dual lead placements targeting the femoral nerve(s) experienced slurred/stuttering speech, and gross motor contractions through the abdomen/shoulders during testing to target placement of their second lead.The system was subsequently removed, including the first lead that the patient received, prior to concluding the placement procedure.Per follow-up submitted to this complaint, the patient received oxygen and an electrocardiogram (ekg) was administered, and there were reportedly no abnormalities identified.The patient's implanting physician reportedly received an update after the procedure that the patient underwent additional testing and results did not appear to be out of normal range for any tests; additional information about which test(s) the patient underwent was not available at the time of complaint investigation.It is unclear from the information available whether the patient's physician was aware of any similar symptoms occurring in this patient prior to the procedure.However, per the complaint submission, the patient has a history of experiencing seizure from medication use >10 years prior to the procedure; given that additional information about the patient's history of these symptoms was not available at the time of investigation, it is unclear whether the patient's prior medical history unrelated to sprint may have contributed to the issue reported in this complaint.Per follow-up submitted to this complaint, the patient's physician reportedly did not believe that the issue was related to sprint or correlated with delivery of stimulation, and he reportedly attributed the issue to stress/tension from undergoing the lead placement procedure.
Event or Problem Description
A patient undergoing dual lead placements targeting the femoral nerve(s) experienced slurred/stuttering speech, and gross motor contractions through the abdomen/shoulders during testing to target placement of their second lead.The system was subsequently removed, including the first lead that the patient received, prior to concluding the placement procedure and the nursing team attended to the patient's health at that time.

• Brand Name: SPRINT
• 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: 18319335
• Report Number: 3011035812-2023-00023
• Device Sequence Number: 6970351
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)241024(10)72585200
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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: 10/24/2024
• Device Model Number: 9600-9288
• Device Lot Number: 72585200
• 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: 11/13/2023
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• 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: Other
• Patient Sex: Female