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

Model Number NIPG1500

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

Patient Problem Death (1802)

Event Date 02/03/2021

Event Type  Death  

Manufacturer Narrative

A review of the available diagnostic data showed no indications of a device malfunction.The manufacturing records were reviewed and no issues were found.The device was not available for return.

Event Description

It was reported to nevro that the patient passed away due to complications from pneumonia.There were no reports of device-related issues from the patient prior to the passing.Nevro attempted to obtain a medical assessment from a healthcare professional to confirm the cause of death but no additional information was available.

• 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: 11396294
• MDR Text Key: 234200110
• Report Number: 3008514029-2021-00082
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020015
• UDI-Public: 00813426020015
• 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: 03/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2019
• Device Model Number: NIPG1500
• Device Catalogue Number: NIPG1500
• Device Lot Number: 9440755
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2017
• 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): Death