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

Model Number TLEAD1058-50B

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

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994)

Event Date 07/18/2021

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 to nevro that the patient experienced pocket pain and a fever.Nevro attempted to obtain additional information regarding the nature of the issue but none was available.The device was removed and there have been no reports of further complications regarding this event.

Manufacturer Narrative

This report is to update based on new information.

Event Description

Follow-up indicated that the patient's pocket pain and fever were due to an infection caused by a bandage changed at home.The physician drained the infection and there have been no reports of further complications regarding this event.

• 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: 12316742
• MDR Text Key: 266368090
• Report Number: 3008514029-2021-00323
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020367
• UDI-Public: 00813426020367
• 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,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: TLEAD1058-50B
• Device Catalogue Number: TLEAD1058-50B
• Device Lot Number: 94497169
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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