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

Model Number LEAD3005-50B

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

Patient Problem Reaction (2414)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

The device was not removed.The manufacturing records were reviewed and no non-conformities were found.

Event Description

It was reported to nevro that shortly after the trial procedure the patient vomited multiple times due to a suspected reaction to anesthesia.The patient noted a previous episode (unrelated to the device) of a reaction to anesthesia that resulted in vomiting.The patient was taken to the hospital and has recovered without sequelae.The trial was completed successfully and the patient is currently receiving effective pain relief from the permanent device.

• 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: 8378801
• MDR Text Key: 137440211
• Report Number: 3008514029-2019-00078
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020466
• UDI-Public: 00813426020466
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2021
• Device Model Number: LEAD3005-50B
• Device Lot Number: 50037912
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2018
• 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 Age: 68 YR