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 Problems Hematoma (1884); Paralysis (1997); Swelling/ Edema (4577)

Event Date 11/18/2021

Event Type  Injury  

Event Description

It was reported that three days post-op the patient had stomach swelling and couldn't feel their legs due to a hematoma.The device was removed and the patient was hospitalized.The patient is getting some feeling back in the legs and is currently recovering.

Manufacturer Narrative

The manufacturing records were reviewed and no relevant nonconformities were found.If we later obtain any required information that was not available at the time of this initial report, we will submit a supplemental report.The device was not returned.

• 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: 13031475
• MDR Text Key: 282493736
• Report Number: 3008514029-2021-00563
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LEAD3005-50B
• Device Catalogue Number: LEAD3005-70B
• Device Lot Number: 50070501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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: Male