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

Model Number LEAD1058-50B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned and analyzed.Based on the damage found on the lead, the most likely cause was that the lead caught on a sharp object, such as the needle tip, but the cause was unable to be confirmed.The manufacturing records were reviewed and no issues were found.

Event Description

It was reported to nevro that during the implant procedure, the lead was damaged.The lead was replaced and the procedure completed with no further complications.The device was returned for analysis, which showed an electrode was detached.The patient is currently using their device to find effective pain relief.

• 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: 10638389
• MDR Text Key: 210204008
• Report Number: 3008514029-2020-00739
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020022
• UDI-Public: 00813426020022
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2021
• Device Model Number: LEAD1058-50B
• Device Catalogue Number: LEAD1058-50B
• Device Lot Number: 94435958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2018
• 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