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

Model Number	Endura, Shipping Configuration
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record review was conducted with no anomalies found.No device malfunction is suspected.The patient was taking coumadin at the time of implant due to a rare preexisting bleeding condition, protein s deficiency, that may have contributed to the event.
Event or Problem Description
Patient had some bleeding during percutaneous placement of a microlead in the sciatic popliteal area.After the procedure the patient indicated that he had some pain in the area.The patient had pain overnight and went to the hospital with a hematoma the morning after the procedure.The implanting physician was aware and had been seeing the patient in the hospital.They had stopped his coumadin and he was stabilized.Patient had not been using the stimulator and the microlead was removed.

• Brand Name: SPRINT PNS SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd; ste 110; cleveland OH 44122
• MDR Report Key: 10801454
• Report Number: 3011035812-2020-00001
• Device Sequence Number: 17126448
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)210831(10)M1021052020
• Combination Product (Y/N): N
• PMA/510(K) Number: K181422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 11/05/2020

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: 08/31/2021
• Device Model Number: Endura, Shipping Configuration
• Device Catalogue Number: 9600-9244-60
• Device Lot Number: M1021052020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 11/06/2020
• 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