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

Device Problem Failure to Charge (1085)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient was on a ventilator, due to non ins related issue, and they were unable to recharge the ins.It was a nevro.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INS STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEVRO
• MDR Report Key: 17535291
• MDR Text Key: 321434878
• Report Number: MW5142190
• 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: 01/03/2022

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