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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Irritability (2421)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient commented that they had a nevro scs device that got infected so "they pulled that out." patient was highly escalated, so agent did not gather further details.Agent documented information given.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SPINAL CORD STIMULATOR
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEVRO CORP.
• MDR Report Key: 23110265
• Report Number: MW5176315
• Device Sequence Number: 14746696
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2025
• Patient Sequence Number: 1
• Patient Sex: Unknown