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

Model Number LEAD3005-50B

Device Problem Material Separation (1562)

Patient Problem Neuropathy (1983)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

It was reported that the patient has been feeling a tingling sensation at her feet.She obtained x-rays in office following a hard fall showing the leads have been broken off from the ipg.There has been no lead migration but, the paddle is damaged along with the ipg.The paddle and ipg will be replaced.An hcp assessment regarding the cause of the reported event was not available.The patient doesn't believe the fall was device related.There have been no reports of further complications regarding this event.

Manufacturer Narrative

Section e.Initial reporter (hcp) information is unknown.H1.This case is both serious injury and malfunction.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.

Manufacturer Narrative

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

Additional information indicated that the patient underwent a revision surgery.The system was replaced.

• 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: 18744484
• MDR Text Key: 336413905
• Report Number: 3008514029-2024-00134
• Device Sequence Number: 1
• Product Code: LGW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LEAD3005-50B
• Device Lot Number: 94537732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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
• Treatment: NIPG2500 LOT NO 9453947
• Patient Outcome(s): Other
• Patient Sex: Female