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

Model Number LEAD1058-70B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis of the device is currently in progress.The manufacturing records were reviewed and no issues were found.

Event Description

It was reported to nevro that an electrode detached from the lead while it was being withdrawn from the insertion needle.The detached electrode remains in the subcutaneous tissue and the physician had no concerns.The lead was replaced and the patient continued the trial.Follow-up indicated that there have been no issues with the detached electrode and the physician will remove it at a later time.

Manufacturer Narrative

The device was returned, missing one electrode on the distal end.Visual inspection of the damaged area showed an indentation going towards the distal end tip.The damaged was most likely caused when the lead caught on a sharp object such as the needle tip, but the cause unable to be confirmed.

Event Description

The device was returned and analyzed.

• 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: 10736785
• MDR Text Key: 214636908
• Report Number: 3008514029-2020-00765
• 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,Followup
• Report Date: 01/28/2021

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: 02/20/2023
• Device Model Number: LEAD1058-70B
• Device Catalogue Number: LEAD1058-70B
• Device Lot Number: 94470852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2020
• 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