MAUDE Adverse Event Report: UNKNOWN IMPLANTABLE NEUROSTIMULATION SYSTEM; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 2413

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

It was reported patient had bad stim in their back and the charging unit was not working for them for they had trouble.Patient said they had a nuvectra with serial number (b)(6) and model 2413.Ps redirected caller to call nuvectra customer service.Ps did not obtain hcp or event date as pt was not trained on device and pt was wanting to get off phone.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTABLE NEUROSTIMULATION SYSTEM
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17535501
• MDR Text Key: 321462245
• Report Number: MW5142397
• 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: 11/19/2021

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
• Device Model Number: 2413
• Patient Sequence Number: 1