MAUDE Adverse Event Report: NEVRO CORP SENZA; NEVRO SENZA

Model Number NIPG1500

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

Patient Problem Sepsis (2067)

Event Date 08/29/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.The manufacturing and sterilization records for all implanted devices associated with this event were reviewed and no nonconformities were found.

Event Description

It was reported to nevro that a patient was admitted to the er and hospitalized a few hours after implant.Blood cultures were negative for infection but sepsis was suspected and the device was explanted.The implanting physician believes that there may be other underlying reasons for rapid sepsis development following surgery but no additional information is currently available.Follow up report indicated that the infection has cleared and the patient was discharged.

Manufacturer Narrative

The device was not explanted.The patient had recovered from the infection and continued to use the device.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP; 1800 bridge parkway; redwood city CA 94065
• Manufacturer Contact: rey nossa ; 1800 bridge parkway; redwood city, CA 94065 ; 6504332742
• MDR Report Key: 5964567
• MDR Text Key: 55205241
• Report Number: 3008514029-2016-00083
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020015
• UDI-Public: 00813426020015
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

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: Physician
• Device Expiration Date: 04/21/2018
• Device Model Number: NIPG1500
• Device Catalogue Number: NIPG1500
• Device Lot Number: 9437230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/20/2016
• Supplement Dates Manufacturer Received: 08/29/2016
• Supplement Dates FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2016
• 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: 75 YR