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

Model Number TLEAD1058-70B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/10/2020

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 when the physician pulled the lead back out of the insertion needle, the most distal electrode detached from the lead.The physician had no concerns leaving the detached electrode in place and the lead was replaced.The patient successfully completed the trial with effective pain relief.

• 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: 9783114
• MDR Text Key: 182145563
• Report Number: 3008514029-2020-00475
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020367
• UDI-Public: 00813426020367
• 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
• Report Date: 03/03/2020

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: 09/23/2022
• Device Model Number: TLEAD1058-70B
• Device Catalogue Number: TLEAD1058-50B
• Device Lot Number: 94457863
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• 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
• Patient Age: 49 YR