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

Model Number	TLEAD1058-50B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Pain (1994)
Date of Event	07/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing records were reviewed and no relevant nonconformities were found.The device was not returned.
Event or Problem Description
It was reported to nevro that the patient experienced pocket pain and a fever.Nevro attempted to obtain additional information regarding the nature of the issue but none was available.The device was removed and there have been no reports of further complications regarding this event.
Additional Manufacturer Narrative
This report is to update based on new information.
Event or Problem Description
Follow-up indicated that the patient's pocket pain and fever were due to an infection caused by a bandage changed at home.The physician drained the infection and there have been no reports of further complications regarding this event.

• Brand Name: SENZA
• Common Device Name: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 12316742
• Report Number: 3008514029-2021-00323
• Device Sequence Number: 4301160
• Product Code: LGW
• UDI-Device Identifier: 00813426020367
• UDI-Public: 00813426020367
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: TLEAD1058-50B
• Device Catalogue Number: TLEAD1058-50B
• Device Lot Number: 94497169
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/18/2021
• Supplement Date Received by Manufacturer: 07/18/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other