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

Model Number LEAD1058-70B

Device Problem Fracture (1260)

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

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturing records were reviewed and no issues were found.A review of the complaint record has found no other instances of similar events for this lot.The device was not available for return.

Event Description

It was reported to nevro that the patient felt a pop in the back when they picked up their daughter.During the removal of the device, it was found that the lead had a fracture near the anchor site.There have been no reports of further complications regarding this event.

• 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: 11121056
• MDR Text Key: 226089505
• Report Number: 3008514029-2021-00007
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020046
• UDI-Public: 00813426020046
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: LEAD1058-70B
• Device Catalogue Number: LEAD1058-70B
• Device Lot Number: 94455978
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2019
• 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: 33 YR