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

Model Number TLEAD1058-70B

Device Problems Material Frayed (1262); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned and investigated at nevro.Visual examination of the device found the lead was frayed at the distal end and one electrode was missing.The exact root cause of the damage is likely due to the surgical procedure when attempting to advance the lead after multiple attempts.The manufacturing records were reviewed and no non-conformities related to the nature of the complaint were found.

Event Description

It was reported to nevro that during a trial procedure, the physician was unable to advance the lead after several attempts.The lead was removed and no injuries were sustained by the patient.There were no reports of detached components from the lead.However, the lead was returned and upon investigation, a missing electrode was noted.The patient had a successful trial and now has been implanted with the permanent device and has been using the device with effective pain relief.

Manufacturer Narrative

This follow-up was submitted to add (b)(4).

• 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: 7967956
• MDR Text Key: 123806160
• Report Number: 3008514029-2018-00444
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020374
• UDI-Public: 00813426020374
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2020
• Device Model Number: TLEAD1058-70B
• Device Catalogue Number: TLEAD1058-70B
• Device Lot Number: 94415864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2017
• 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 Age: 53 YR