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

Model Number LEAD1058-90B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

A1.Patient identifier exceeds character limit.Patient id: (b)(6).The manufacturing records were reviewed and no relevant nonconformities were found.Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803.Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this time.However, we may not have been able to confirm this information or complete the investigation within the timeframe for filing this report.We may have given no response or an incomplete response to certain questions because we do not currently have information available to provide a complete response.If we later obtain any required information that was not available at the time of this initial report, we will submit a supplemental report.This report is not an admission by anyone that the product described in this report was defective, that it malfunctioned, or that it caused or contributed to the event described in this report.We may conclude that the device had no defect, did not malfunction, or did not cause or contribute to a reportable event.Some of the items on this form include forced-choice terms used by the fda for reporting purposes that do not necessarily reflect nevro¿s conclusions about the causes or nature of the event.This statement should be included with any freedom of information act response.

Event Description

It was reported that during the implant procedure, the distal end tip of the lead became detached.Patient's complex spine structure led to an abnormal lead angle during insertion, resulting in lead fracture and contact detachment.Upon removal, the physician noted that electrode 1 at the distal end was missing, along with damage to the outer casing.The physician decided not to proceed with the removal of the electrode from the patient's body, asserting that the component is located in a safe area.The implant surgery was successfully completed with one lead.There have been no reports of further complications regarding this event.

Manufacturer Narrative

The device was returned and analyzed.The investigation revealed that the returned lead was missing the distal contact for e1, with damage to the pellethane material at both ends of the contact location.The aligned damage suggested a common external force, likely from the insertion needle.The root cause was likely mishandling by the implanting physician, possibly due to incorrect stylet usage or errors in navigating the epidural space.The patient's anomalous anatomy contributed to removal difficulties but is not considered to be the primary root cause.The manufacturing records were reviewed and no relevant nonconformities were found.Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803.Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this time.However, we may not have been able to confirm this information or complete the investigation within the timeframe for filing this report.We may have given no response or an incomplete response to certain questions because we do not currently have information available to provide a complete response.If we later obtain any required information that was not available at the time of this initial report, we will submit a supplemental report.This report is not an admission by anyone that the product described in this report was defective, that it malfunctioned, or that it caused or contributed to the event described in this report.We may conclude that the device had no defect, did not malfunction, or did not cause or contribute to a reportable event.Some of the items on this form include forced-choice terms used by the fda for reporting purposes that do not necessarily reflect nevro¿s conclusions about the causes or nature of the event.This statement should be included with any freedom of information act response.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• Manufacturer Contact: zulfiqar ali ; 1800 bridge parkway; redwood city, CA 94065 ; 6505317627
• MDR Report Key: 17845755
• MDR Text Key: 324617996
• Report Number: 3008514029-2023-00578
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020053
• UDI-Public: 00813426020053
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: LEAD1058-90B
• Device Lot Number: 94541212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• 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 Outcome(s): Other