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U.S. Department of Health and Human Services

Class 2 Device Recall Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer,

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  Class 2 Device Recall Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, see related information
Date Initiated by Firm April 06, 2016
Date Posted May 03, 2016
Recall Status1 Terminated 3 on September 29, 2017
Recall Number Z-1600-2016
Recall Event ID 73884
PMA Number P130028 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5.

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.

The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator. In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs
Code Information Serial 000010 000011 FF0043 FF0045 000014 000015 000016 FF0054 FF0048 FF004B FF005D FF0064 FF0065 FF0067 FF00A9 FF00AD FF00BB   Lot  P178713 P185700 P187989 P195875 P213108 P257056   
Recalling Firm/
Manufacturer		 Nuvectra
10675 Naples St NE
Blaine MN 55449-5802
For Additional Information Contact Anne Marie Reali
612-219-0117
Manufacturer Reason
for Recall		 If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (lPG). This may result in the user being unable to recharge the lPG. This safety notice only applies to CPs Model 4500.
FDA Determined
Cause 2		 Software design
Action Nuvectra sent an "Urgent Field Safety Notice" letter dated April 6, 2016 to customers. The letter identified the affected product, problem, recommendations and Mitigations, and actions to be taken.
Quantity in Commerce 17 OUS
Distribution Germany
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LGW and Original Applicant = Nuvectra Corporation
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