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

Model Number	9600-9288
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for investigation, but based on the provided information, there is no evidence of a device malfunction.The physician reported having difficulty visualizing the stimulating probe tip under ultrasound; however, there have been no other known reports of difficult visualizing the components under ultrasound during over 500 procedures by other physicians.The implant procedure was targeting the intercostal nerve at the t9 level using an approach similar to an intercostal nerve block and pneumothorax is a known complication of performing an intercostal nerve block (documented rates range from 0.5% to 5.6%).This is the first report of pneumothorax during the placement of the sprint device, and over 150 procedures have been performed in which one or more intercostal nerves were targeted.This suggests that the likelihood of pneumothorax when implanting the sprint device is comparable to that of performing an intercostal nerve block.
Event or Problem Description
Patient had a complication and device placement couldn't be completed.During placement of the stimulating probe near the intercostal nerve at the t9 level, the patient experienced vasovagal syncope.He was moved off the table and into post-op to get his vitals under control.A chest x-ray showed a pneumothorax and he was moved to the er for a chest tube.The patient was stabilized, kept for observation overnight, and was released with no further complication and no known lasting effects.

• Brand Name: SPRINT PNS SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATION SYSTEM
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd; suite 110; cleveland OH 44122
• MDR Report Key: 11821785
• Report Number: 3011035812-2021-00002
• Device Sequence Number: 1153731
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)221112(10)M1165022021
• Combination Product (Y/N): N
• PMA/510(K) Number: K202660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2021

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: 11/12/2022
• Device Model Number: 9600-9288
• Device Catalogue Number: 9600-9288
• Device Lot Number: M1165022021
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention