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	Nerve Damage (1979); Pain (1994); Burning Sensation (2146)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury

• Brand Name: Senza
• Common Device Name: Nevro Senza
• Manufacturer (Section D): Nevro Corp.; 1800 bridge parkway; redwood city CA 94065
• Manufacturer Contact: john paxton ; 1800 bridge parkway; redwood city, CA 94065 ; +1(650)433-2730
• MDR Report Key: 50903660
• Report Number: 3008514029-2026-00457
• Device Sequence Number: 12262412
• Product Code: LGW
• UDI-Device Identifier: 00813426021098
• UDI-Public: 00813426021098
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P130022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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 Model Number: TLEAD1058-50B
• Device Lot Number: 94586074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male