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 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturing records were reviewed and no issues were found.The device was not available for return.

Event Description

It was reported to nevro that during the trial procedure the physician had difficulty placing the lead.When the lead was pulled back out of the insertion needle, the most distal electrode detached from the lead.The physician decided to leave the detached electrode in place and the patient successfully completed the trial with effective pain relief.The patient will have the permanent device implanted in the future and will review options regarding the detached electrode with the neurosurgeon.

Manufacturer Narrative

The device was returned and analyzed.The investigation found an indentation on the edge of one side of the electrode, indicating that the electrode caught on a sharp edge.It was reported that the failure occurred during positioning of the lead while inserting into an insertion needle, therefore the catch point was likely the insertion needle.The manufacturing records were reviewed and no issues were found related to the nature of the complaint.

Event Description

The device was returned and analyzed.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 9742267
• MDR Text Key: 182785020
• Report Number: 3008514029-2020-00467
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2022
• Device Model Number: TLEAD1058-50B
• Device Catalogue Number: TLEAD1058-50B
• Device Lot Number: 94459777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1