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

Model Number LEAD1058-70B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to nevro that during the implant procedure, one electrode had detached from the lead and was left in the epidural space.The patient did not sustain any injuries.The physician does not plan to remove it and will continue to monitor the patient.The lead was replaced and the implant procedure completed with no reports of further complications.The patient is currently using the device and pleased with the pain relief.

Manufacturer Narrative

The lead was returned for analysis.The most distal electrode and the lead body at the tip were missing.The conductor wires were exposed and high magnification imaging showed the wire strands were necked and fractured.An insertion needle likely dragged across the surface of the lead during lead withdrawal, which led to the needle catching onto the distal electrode, resulting in the fracture of the device.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 8550370
• MDR Text Key: 143382600
• Report Number: 3008514029-2019-00170
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020046
• UDI-Public: 00813426020046
• 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
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2021
• Device Model Number: LEAD1058-70B
• Device Catalogue Number: LEAD1058-70B
• Device Lot Number: 94439326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR