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FDA-Device2016-12-28Class II

Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 12-electrode Lead Kit. Model Number (s) 112x-xx (CT), 108x-xx(T). These are part of the Algovita Spinal Cord Stimulation System. The Algovi

Nuvectra
Hazard

Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System. It has been reported that in some percutaneous leads, the stylet protruded beyond the distal lead tip.

Sold states
US: Nationwide (CA, TX, KY, FL, IL,PA,OH, GA, NJ, NC, KS, AR, CO, NE, NY, VA, AZ, OK). OUS: Germany
Affected count
406 OUS, 985 US
Manufactured in
10675 Naples St NE, N/A, Blaine, MN, United States
Products
Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 12-electrode Lead Kit. Model Number (s) 112x-xx (CT), 108x-xx(T). These are part of the Algovita Spinal Cord Stimulation System. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient s use of the system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0781-2017

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