MAUDE Adverse Event Report: NEVRO CORP. SENZA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	EXTS3500
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The neurosurgeon reported that the device impedances were checked and found to be persistently elevated along three contacts.

• Brand Name: SENZA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge pkwy.; redwood city CA 94065
• MDR Report Key: 25067476
• Report Number: 25067476
• Device Sequence Number: 16139193
• Product Code: LGW
• UDI-Device Identifier: 00813426020770
• UDI-Public: (01)00813426020770
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2026
• Report Date (Section F): 04/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EXTS3500
• Device Catalogue Number: EXTS3500
• Device Lot Number: 9460745
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Date Report Sent to FDA: 04/10/2026