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

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2021

Event Type  Injury  

Event Description

Patient mentioned he had the nevro scs implanted in (b)(6) 2020 and it did not do anything and did not work.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SPINAL CORD STIMULATOR (SCS)
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEVRO
• MDR Report Key: 17527290
• MDR Text Key: 321104912
• Report Number: MW5134223
• 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: 04/07/2021

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