MAUDE Adverse Event Report: NEVRO CORP. SENZA; NEVRO SENZA

Model Number NIPG2500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Paralysis (1997); Vomiting (2144)

Event Date 01/05/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturing records were reviewed and no relevant nonconformities were found.The device was not returned.

Event Description

It was reported that the patient experienced vomiting due to the anesthesia from the implant procedure.The vomiting led to a loss of left leg movement due to an epidural hematoma.The physician believes the vomiting tore something, resulting in the epidural hematoma.The device was removed and the patient remains under medical supervision.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• Manufacturer Contact: catherine aronson ; 1800 bridge parkway; redwood city, CA 94065 ; 6504333218
• MDR Report Key: 13424845
• MDR Text Key: 284888283
• Report Number: 3008514029-2022-00056
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020602
• UDI-Public: 00813426020602
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NIPG2500
• Device Catalogue Number: NIPG2500
• Device Lot Number: 9450974
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female