MAUDE Adverse Event Report: ALGOVITA SPINAL CORD STIMULATION SYSTEM; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Device Problems Break (1069); Material Frayed (1262); Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported on the implant of the previous ins, the surgeon used a preexisting incompatible lead, from nuvectra, and the patient got good coverage.Today we were going to change the battery and the lead was damaged pulling it out of the previous ins.The dr is not a surgeon and could not replace the paddle lead.The new ins was already opened to get the wrench.Dr implanted the new ins with two plugs in the ports, so we can use it when we replace the lead with a surgeon.Furthermore it was reported that the leads were fractured, damaged, or broken.The nuvectra lead frayed when it was pulled out of the previous ins, and rep states they will replace the nuvectra lead with a compatible manufacturer's lead.Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

Event Description

Additional information received on 11/24/2023 for report mw5147571 to update the manufacturer.Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ALGOVITA SPINAL CORD STIMULATION SYSTEM
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• MDR Report Key: 18047071
• MDR Text Key: 327147486
• Report Number: MW5147571
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2023
• Patient Sequence Number: 1