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

Model Number LEAD1058-90B

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

Nevro is awaiting the return of the device.The manufacturing records were reviewed and no non-conformities were found.

Event Description

It was reported that during a lead revision, x-rays showed one electrode had detached from the lead and was left in the epidural space.The physician removed the lead and confirmed there was a missing electrode.The physician was not concerned about the detached electrode and did not plan to remove it.The lead was replaced and there have been no reports of further complications regarding this event.The patient is currently using the device to find effective therapy.

Manufacturer Narrative

The device was returned for analysis.Visual inspection found the first electrode was missing from the distal end.Review of the diagnostic data showed the electrode was functional at the time of implant but during the course of the implant period the impedance fluctuated and eventually showed open prior to the revision procedure.High-magnification revealed consistent necking and fracture of each individual conductor wire.The root cause of the failure was undetermined but was likely due to a large flexural strain.

• 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: 8404775
• MDR Text Key: 139839588
• Report Number: 3008514029-2019-00064
• Device Sequence Number: 0
• Product Code: LGW
• 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: 06/14/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2020
• Device Model Number: LEAD1058-90B
• Device Catalogue Number: LEAD1058-90B
• Device Lot Number: 94394491
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• 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