MAUDE Adverse Event Report: NEVRO CORP SENZA; NEVRO SENZA

Model Number LEAD1058-70B

Device Problems Detachment Of Device Component (1104); Difficult to Insert (1316); Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2017

Event Type  malfunction  

Manufacturer Narrative

Nevro is awaiting for the return of the device.

Event Description

It was reported to nevro that during a permanent procedure, the physician had difficulty accessing the epidural space in a patient with severe fibrosis in lower spine.After several attempts to insert the percutaneous lead, he retracted the lead and noted that the top contact was missing.The case was aborted and the detached contact remained in the epidural space.There was no report of further complication.

Manufacturer Narrative

Visual inspection of the returned lead found that the top contact was separated from the lead body.Microscope inspection of the detached electrode showed a narrow indentation on the proximal end of the electrode.This indentation is indicative of the lead tip being caught on a sharp edge most likely the edge of the insertion needle.Unable to easily remove the lead, the user forced the lead through the needle causing the separation.This is evidenced by the necking and fractures of the leads observed under the microscope.This appears to be a unique event and will be monitored for any developing trend.The materials used in the nevro lead have been determined to be biocompatible.

Manufacturer Narrative

Visual inspection of the returned lead found that the top contact was separated from the lead body.Microscope inspection of the detached electrode showed a narrow indentation on the proximal end of the electrode.This indentation is indicative of the lead tip being caught on a sharp edge most likely the edge of the insertion needle.Unable to easily remove the lead, the user forced the lead through the needle causing the separation.This is evidenced by the necking and fractures of the leads observed under the microscope.This appears to be a unique event and will be monitored for any developing trend.The materials used in the nevro lead have been determined to be biocompatible.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP; 1800 bridge parkway; redwood city CA 94065
• Manufacturer Contact: rey nossa ; 1800 bridge parkway; redwood city, CA 94065 ; 6504332742
• MDR Report Key: 6737812
• MDR Text Key: 80997649
• Report Number: 3008514029-2017-00182
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020046
• UDI-Public: 00813426020046
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/03/2020
• Device Model Number: LEAD1058-70B
• Device Catalogue Number: LEAD1058-70B
• Device Lot Number: 94398152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• 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