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

Model Number TLEAD1058-50B

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis of the returned 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, the physician found detached electrodes from trial leads left behind in the epidural space.The trialing physician had noted no issues when the trial leads were removed.The implanting physician has removed all but one electrode and currently has no plans to retrieve the remaining electrode.The procedure was completed without further complications and the patient is currently using their device with effective pain relief.

Manufacturer Narrative

The lead fragment was returned and analyzed.Visual inspection of the returned device showed a scratch, and flattened contacts.Diagnostic data showed all lead impedances of contacts were functional and within normal range for the whole trial period.Based on patient data and the reported information the lead was fractured and damaged during the removal of the leads.The patient anatomy anomaly was a contributor factor that mostly likely caused resistance and difficulty during removal of the leads.The manufacturing records were reviewed and no non-conformities were found.

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
• Manufacturer Contact: catherine aronson ; 1800 bridge parkway; redwood city, CA 94065 ; 6504333218
• MDR Report Key: 10708953
• MDR Text Key: 213697470
• Report Number: 3008514029-2020-00758
• 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,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: TLEAD1058-50B
• Device Catalogue Number: TLEAD1058-50B
• Device Lot Number: 94466682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2020
• 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