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

Model Number NIPG2000

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

Patient Problems Neurological Deficit/Dysfunction (1982); Paralysis (1997)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturing records were reviewed and no issues were found.H3 other text : the device was not available for return.

Event Description

It was reported to nevro that shortly after the implant procedure the patient experienced a loss of motor function.Pre-existing conditions may have contributed to the incident and the physician does not believe the issue was related to the device.The device was never activated and removed.There have been no reports of further complications regarding this event.

Manufacturer Narrative

(b)(4).

Event Description

Follow-up indicated that the patient was paralyzed.The physician confirmed there was no problem with the device or the procedure that contributed to this incident.

• 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: 10736814
• MDR Text Key: 213220222
• Report Number: 3008514029-2020-00763
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020510
• UDI-Public: 00813426020510
• 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: 12/30/2020

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: 10/10/2021
• Device Model Number: NIPG2000
• Device Catalogue Number: NIPG2000
• Device Lot Number: 5004836
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other