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

Model Number TLEAD1058-50B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

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 trial procedure, the physician encountered resistance while placing the leads due to patient's anatomy and significant scar tissues.During lead placement, detachment of one electrode was observed and it was confirmed through x-ray that the detached electrode was not in the epidural space.There were no injuries to the patient and the physician decided to remove the electrode during the permanent implant procedure.There have been no reports of further complications regarding this event.

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 and resulting in 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: 8641403
• MDR Text Key: 146212078
• Report Number: 3008514029-2019-00200
• 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
• Report Date: 08/06/2019

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: 01/24/2022
• Device Model Number: TLEAD1058-50B
• Device Catalogue Number: TLEAD1058-50B
• Device Lot Number: 94443651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR