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

Model Number LEAD1058-70B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturing records were reviewed and no issues were found related to the nature of the complaint.

Event Description

It was reported to nevro that the patient's x-rays showed that an electrode may have detached from the lead.The patient has not sustained any injuries and there are currently no plans to address the issue.

Manufacturer Narrative

The device was not available for return.

Event Description

Follow-up indicated that the patient continued to use their device with effective pain relief.The incident may have occurred after the patient fell while hiking.The physician replaced the lead and there are no plans to remove the detached contact.

• 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
• MDR Report Key: 9663110
• MDR Text Key: 178029174
• Report Number: 3008514029-2020-00007
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

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: 03/29/2020
• Device Model Number: LEAD1058-70B
• Device Catalogue Number: LEAD1058-70B
• Device Lot Number: 94398082
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR