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

Model Number NIPG2000

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

Patient Problem Stroke/CVA (1770)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturing records were reviewed and no issues related to the nature of the complaint were found.The device was not removed.

Event Description

It was reported to nevro that the patient experienced a stroke.It was believed that the stroke was not related to the device.Nevro attempted to confirm the medical assessment but no additional information was available.There have been no reports of further complications regarding this event.

Event Description

Follow-up indicated that the physician did not believe the stroke was related to the device.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 9227732
• MDR Text Key: 163546091
• Report Number: 3008514029-2019-00456
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020510
• UDI-Public: 00813426020510
• Combination Product (y/n): N
• PMA/PMN Number: P130022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2020
• Device Model Number: NIPG2000
• Device Catalogue Number: NIPG2000
• Device Lot Number: 9441872
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other