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

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported sometime around (b)(6) 2021 it was discovered that pt's lead was hyper active and they couldn't have an mri done.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NEVRO STIMULATOR LEAD
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEVRO
• MDR Report Key: 17529809
• MDR Text Key: 321427690
• Report Number: MW5136732
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1