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

Model Number TLEAD1058-50B

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned.Analysis of the device is currently in progress.The manufacturing records were reviewed and no non-conformities were found.

Event Description

It was reported to nevro that during the trial procedure the lead entered into the incorrect space.As the physician was withdrawing the lead from the epidural space, the distal end of the lead sheared off.As a result, the four distal electrodes detached from the lead and were left in the tissue.The physician was able to retrieve all parts of the lead.No injuries were sustained by the patient.

Manufacturer Narrative

One lead was returned and investigated at nevro.The lead being sheared in two pieces was confirmed.Visual inspection found the lead sheared in the contact area.High magnification of the top piece showed one contact to be deformed and pulled from the external body.Damage to the bottom piece showed the external body stretched, thus exposing the conductor wire.The exact root cause of the damage likely occurred during the surgical procedure when attempting to withdraw the lead from the epidural space.

Manufacturer Narrative

A voluntary medwatch report number mw5083467 was received.Follow-up clarified that the lead did not enter the incorrect space, but rather entered the epidural space and went ventral.It was confirmed that there were no further complications regarding this event and the patient will likely be trialed again.Analysis of the device is currently in progress.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 8341826
• MDR Text Key: 136268435
• Report Number: 3008514029-2019-00061
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020367
• UDI-Public: 00813426020367
• Combination Product (y/n): N
• PMA/PMN Number: P130022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2021
• Device Model Number: TLEAD1058-50B
• Device Catalogue Number: TLEAD1058-50B
• Device Lot Number: 94430003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR