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

Model Number	9600-9244-60
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: spr peripheral nerve stimulator lead was removed during office visit and patient tolerated the lead removal without issue.It was not entirely clear if the lead tip was intact.Right sided pelvic x-ray ordered to possibly determine if lead tip is indeed retained.Spr device rep notified as well.Patient given mri safety card in the event he would need to have this for the future.
Additional Manufacturer Narrative
This report is a response to uf report # (b)(4), which was received by spr therapeutics from the fda on 03/09/2021.Based on the provided information, the complaint is not a reportable malfunction per 21 cfr section 803.This device malfunction did not cause or contribute to a death or serious injury and would not be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.The sales rep confirmed that the lead looked fractured upon removal, but the x-ray was negative for retained lead tip fragment.The device was disposed of, so a visual and functional evaluation could not be performed to confirm the lead fracture.Based on the provided information, the reported problem is not believed to have been caused by a manufacturing defect.The product labeling states that the lead may fracture.Complaint # (b)(4) was assigned to this report.

• Brand Name: SPRINT PNS SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd; suite 110; cleveland OH 44122
• MDR Report Key: 11576614
• Report Number: 3011035812-2021-00001
• Device Sequence Number: 14352329
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)210831(10)M1065102020
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K202660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 9600-9244-60
• Device Catalogue Number: 9600-9244-60
• Device Lot Number: M1065102020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1