MAUDE Adverse Event Report: NERVO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number UNKNOWN SCS DEVICE

Device Problem Output Problem (3005)

Patient Problem Device Overstimulation of Tissue (1991)

Event Type  malfunction  

Event Description

It was reported that the patient had a revision done on their device, because they were getting over stimulation.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NERVO
• MDR Report Key: 17537021
• MDR Text Key: 321433877
• Report Number: MW5143902
• 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: 03/17/2020

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
• Device Model Number: UNKNOWN SCS DEVICE
• Patient Sequence Number: 1