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

Model Number	9600-9244-60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient experienced a spike in their blood pressure and their leads were subsequently removed five days after lead placement.
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 spike in their blood pressure and their leads were subsequently removed five days after lead placement.Per an update from a representative in contact with the patient, the patient reportedly has a history of experiencing spikes in blood pressure when receiving injections (e.G., steroid injections) and during other uses of needles.The patient was reportedly "doing fine" and was not experiencing any issues or concerns on the day after lead placement, per a check-in documented on that day, other than disconnection of his magnetic coupler during the prior evening.However, correspondence that was later attached to the complaint submission suggests that the patient's blood pressure spike reportedly lasted from the day that the patient underwent lead placement until the day that their lead was removed.Therefore, it is unclear whether the issue in this complaint could be related to use of needles during lead placement.Note that the patient reportedly received a single lead targeting the suprascapular nerve, and there is no anticipated stimulation pathway at this location that is known to be capable of directly impacting blood pressure.Given that the patient previously experienced blood pressure spikes prior to sprint treatment, it is possible that the issue in this complaint may have been associated with the patient's pre-existing medical history unrelated to sprint.It is also possible that numerous other common causes of hypertension may have caused or contributed to the issue reported in this complaint (e.G., stress, anxiety, diet, physical activity, medications, acute pain, other medical conditions, etc.).It is not suspected that the sprint product was faulty or had any specific deficiency based on the information available in this report.Given that the patient's blood pressure reportedly normalized after their lead was removed and there were no other reported treatments for the issue, no lasting effects are anticipated, and no further investigation is required.It is unclear from the information available whether there was a causal relationship between the issue and sprint treatment.

• Brand Name: SPRINT
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd.; ste. 500; cleveland OH
• Manufacturer (Section G): SPR THERAPEUTICS; 22901 millcreek blvd.; ste. 500; cleveland OH
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; ste. 500; cleveland, OH
• MDR Report Key: 18110234
• Report Number: 3011035812-2023-00020
• Device Sequence Number: 15426629
• Product Code: NHI
• UDI-Device Identifier: 00854001007540
• UDI-Public: (01)00854001007540(17)240907(01)68957575
• Combination Product (Y/N): N
• 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): 11/10/2023

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: 09/07/2024
• Device Model Number: 9600-9244-60
• Device Lot Number: 68957575
• 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: 10/11/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2023
• 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: Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Male