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

Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Malfunction
Event or Problem Description
Patient reported their nevro leads moved in 2021 and had them put back in place in 2021.Pt got an infection and their nevro system had to be explanted.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NEVRO LEAD
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEVRO
• MDR Report Key: 17526932
• Report Number: MW5133869
• Device Sequence Number: 14855024
• Product Code: LGW
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2022

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown