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 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

Nevro is awaiting the return of the device.The manufacturing records were reviewed and no non-conformities were found.

Event Description

It was reported to nevro that the during the implant procedure the most distal electrode sheared off from the lead when the physician pulled the lead out after entering in the epidural space.X-rays confirmed the detached electrode was inside the patient.The procedure finished with no further incidents and the trial was completed.The physician is currently coordinating with a surgeon to remove the electrode.

Manufacturer Narrative

The device was returned and analyzed.Analysis of the returned lead shows that the lead was dragged across a sharp surface, likely the sharp end of an insertion needle during lead withdrawal, resulting in cuts along the surface of the lead.This is likely due to the needle orientation was not as intended, leading to the needle catching onto electrode 1 and resulting in the fracture of the device.The manufacturing records were reviewed and no issues were found.

• 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: 8489639
• MDR Text Key: 141449196
• Report Number: 3008514029-2019-00122
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020374
• UDI-Public: 00813426020374
• 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: 05/21/2019

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: 08/30/2021
• Device Model Number: TLEAD1058-70B
• Device Catalogue Number: TLEAD1058-70B
• Device Lot Number: 94434596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2018
• 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: 46 YR