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

Model Number NIPG2500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burning Sensation (2146)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

Nevro is awaiting the return of the device.The manufacturing records were reviewed and no relevant nonconformities were found.

Event Description

It was reported to nevro that the patient experienced a burning sensation at the pocket site.The physician is going to replace the device.

Manufacturer Narrative

The device was returned and analyzed.Visual inspection of the returned device did not find any anomaly.Functional testing was performed and the device operated to specifications.Review of the device's diagnostic data also showed no evidence of a device 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.

Event Description

Follow up indicated that the physician replaced the device and relocated the pocket site.There have been no reports of further complications regarding this event.The device was returned and analyzed.

• 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: 12144014
• MDR Text Key: 260933249
• Report Number: 3008514029-2021-00251
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020602
• UDI-Public: 00813426020602
• 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: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: NIPG2500
• Device Catalogue Number: NIPG2500
• Device Lot Number: 9447723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2020
• 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
• Patient Age: 23 DA
• Patient Sex: Female