Retiro De Equipo (Recall) de Algovita Spinal Cord Stimulation (SCS) System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Nuvectra.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
  • Causa
    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.
  • Acción
    Nuvectra field sales associate or contracted distributor were sent a Nuvectra Urgent Field Safety Notice (Field Action Number: 2016-03) on 10/11/2016 via Fed-Ex. The letter provided background information, described the problem, & the product involved in the recall. The letter listed the potential clinical implications, rate of occurrence, recommendations and mitigations and action needed. Provided consignees with notices for them to deliver to physicians as well as Response forms for them and the physician. For questions contact Kathy Jo Fahery +01.763.951.8219.


  • Modelo / Serial
    Lot Numbers: W2886402 , W2888100 , W2904692, W2909622 , W2909623 , W2912562 , W2918496, W2918506 , W2930816, W2930816 , W2938384 , W2939156 , W2943651 , W2946424 , W2952157 , W2964008 , W2964009, W2964009 , W2964010, W2964010 , W2964011 , W2972187 , W2978500 , W2981155, W2981155 , W2988382, W2988382 , W3040781 , W3041965, W3041965 , W3043467, W3048908, W3052511 , W3052514, W3052515 , W3057023, W3057024, W3057027, W3057033, W3057033 , W3063066, W3063073, W3063073 , W3088964, W3110760 , W3111249, W3114108, W3119243, W3123219 , W3123220, W3123220 , W3124197, W3127472, W3127472 , W3127473, W3133254, W3133264 , W3135521, W3232789, W3232789 , W3232790, W3232791, W3232792, W3232792 , W3236234, W3236235, W3236237, W3236239, W3236239 , W3321458 , W3321459 , W3321460 , W3321461 , W3321463 , W3321464, W3324818 , W3324820, W3324821 , W3324826 , W3324827, W3324829 , W3324830 , W3335022, W3335022 , W3335027, W3335033 , W3335041 , W3335050, W3335050 , W3335055, W3335055 , W3343777, W3343777 , W3348715 , W3356371, W3356371 , W3357155, W3357155 , W3357157 , W3357159, W3357159 , W3357160 , W3357162, W3357164 , W3357167, W3357169 , W3362186 , W3362187, W3362187 , W3362188, W3362188 , W3362209 , W3374818 , W3374820, W3374821 , W3374823 , W3378359, W3378360, W3389104, W3389105 , W3389112, W3389117 , W3393665 , W3393666 , W3393667, W3393668 , W3396586 , W3396603, W3396608, W3396609 , W3399272 , W3424531, W3424531 , W3424542, W3424565 , W3424585, W3424586, W3424586 , W3424589, W3424591 , W3424593, W3424599, W3424602, W3424616 , W3424623 , W3424627 , W3442616 , W3442617, W3442617 , W3442618, W3442618 , W3442619 , W3448170, W3448171, W3448172 , W3448173 , W3448174 , W3454201 , W3454202 , W3462791 , W3462792 , W3462794, W3462795, W3462795 , W3462796, W3462797, W3462798, W3472638, W3472639, W3472639 , W3472640 , W3472641, W3472641 , W3475288, W3475289, W3475289 , W3475290, W3475290 , W3475291, W3475291 , W3493137, W3498560, W3498562, W3498564, W3504760, W3504762, W3504763, W3504766 , W3506847, W3506848, W3506851, W3536038 , W3536039, W3536039 , W3539484, W3540924.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US: Nationwide (CA, TX, KY, FL, IL,PA,OH, GA, NJ, NC, KS, AR, CO, NE, NY, VA, AZ, OK). OUS: Germany
  • Descripción del producto
    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.
  • Manufacturer


  • Dirección del fabricante
    Nuvectra, 10675 Naples St NE, Blaine MN 55449-5802
  • Empresa matriz del fabricante (2017)
  • Source