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

Model Number LEAD1058-90B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned but analysis has not been completed yet.The manufacturing records were reviewed and no non-conformities were found.

Event Description

It was reported to nevro that during a lead revision, it was discovered that an electrode had detached from the distal end of the lead.The location of the electrode caused no concerns for the physician and the doctor has decided to leave the detached electrode in situ.A new lead was implanted and there have been no reports of further complications regarding this event.

Manufacturer Narrative

The device was returned and investigated at nevro.Visual examination of the lead found the most distal electrode was missing.X-rays at the implant procedure showed the lead was implanted with the distal end sharply bent.Lead impedances were within normal range until (b)(6) 2018, when the distal electrode impedance became open until the lead was revised.The root cause of the damage is likely due to the lead implanted bent and flexural strain applied to the bent location from continuous stretch movements by the patient.The manufacturing records were reviewed and no non-conformities were found.

• 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: 8262914
• MDR Text Key: 134578534
• Report Number: 3008514029-2019-00012
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020053
• UDI-Public: 00813426020053
• 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: 03/05/2019

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: 11/22/2019
• Device Model Number: LEAD1058-90B
• Device Catalogue Number: LEAD1058-90B
• Device Lot Number: 94386993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2016
• 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