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

Model Number LEAD3005-70B

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

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

The device has not been explanted yet.The manufacturing records were reviewed and no non-conformities were found.

Event Description

It was reported to nevro that the patient developed a new foot pain after implant.The patient alleged there was nerve damage.The implanting physician believes the pain was due to the physical placement of the leads and was not aware of any nerve damage.The patient had used the device to receive effective pain relief; however, has scheduled to explant the device.

• 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: 8209003
• MDR Text Key: 131807672
• Report Number: 3008514029-2018-00564
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020404
• UDI-Public: 00813426020404
• 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: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2020
• Device Model Number: LEAD3005-70B
• Device Lot Number: 94406361
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2017
• 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: 67 YR