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

Model Number ACCK1015

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

The insertion needle was not returned for analysis.This issue has been addressed with the manufacturer and corrective action has been implemented.Review of the severity and occurrence rate for this type of event shows that the overall risk is within acceptable limits.

Event Description

It was reported to nevro that the insertion needle detached from the hub during a trial procedure.It occurred when the physician was removing the needle following lead placement.The physician was able to remove the insertion needle without incident.The trial was completed with no further report of complication.

• 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: 7305355
• MDR Text Key: 101350909
• Report Number: 3008514029-2018-00129
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020183
• UDI-Public: 00813426020183
• 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
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/14/2018
• Device Model Number: ACCK1015
• Device Catalogue Number: ACCK1015
• Device Lot Number: 9436656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• 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 Age: 54 YR