MAUDE Adverse Event Report: NEVRO CORP. SENZA NEVRO SENZA

Model Number LEAD1058-50B

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

Patient Problems Pain (1994); Paralysis (1997); Spinal Cord Injury (2432)

Event Date 09/20/2021

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 leg weakness and pain, and is unable to walk. The device was removed and the patient was transferred to a rehabilitation facility.

• 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: 12657924
• Report Number: 3008514029-2021-00449
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020022
• UDI-Public: 00813426020022
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: LEAD1058-50B
• Device Catalogue Number: LEAD1058-50B
• Device Lot Number: 94498012
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Other