Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO || Product Usage: || The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, || Product Usage: || The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO || Product Usage: || The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO || Product Usage: || The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO || Product Usage: || The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
Lot Number 6210849 Serial Number AVM174.1 Lot Number 6210852 Serial Numbers: AVA560.1, AVA214.1, AVL027.1 Lot Number 6499208 Serial Numbers: AVD426.1, AVA922.1 Lot Number 6263128 Serial Numbers: AVB119.1, AVD400.1, AVA622.1, AVD431.1, AVE633.1, AVK678.1, AVN837.1 Lot Number 6268723 Serial Numbers: AUV770.1, AVW805.1 Lot Number 6278155 Serial Number AVK896.1
Nationwide Distribution -- GA, NC, CA, OK, SC and NJ.
Descripción del producto
Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. || Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Descripción del producto
Eon Mini Neurostimulation (IPG) System (Model 3788); || The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Isreal, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Descripción del producto
Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. || Product Usage: || The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Isreal, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Descripción del producto
The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. || Product Usage: || The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Worldwide Distribution--USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Belgium, Brazil, canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Saudi, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Descripción del producto
Eon Mini - 3788 (IPG), || Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.
Worldwide Distribution - USA Nationwide Including Puerto Rico and countries of: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland and United Kingdom.
Descripción del producto
Eon - 3701 (Wall Charger) and 3711 (Portable Charger). || Product Usage: || Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. Eon Mini: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: Austria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Luxembourg, Martinique, Mexico, Netherlands, Poland, Russian Federal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Descripción del producto
Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 recall. || Product Usage: || The Eon Wall Charger (3701) provides the capability to recharge the IPG Battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The Eon Portable Charger (3711) provides the capability to recharge the IPG battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The patient can be mobile during the recharging process with a portable charger. The Eon Mini Charger (3721) provides the capability to recharge the IPG battery while stimulation is either on or off. The charger transmits RF energy through the antenna to the IPG battery to recharge it.
Worldwide Distribution - USA Nationwide Including Puerto Rico and countries of: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland and United Kingdom.
Descripción del producto
Eon Mini - 3721 (Charger). || Product Usage: || Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). || Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). || Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
Nationwide distribution: AZ, CA, CO, DC, FL, GA, IL, IN, MI, MO, MS, NC, NM, NJ, NV, NY, OH, OK, OR, PA, SC, TN, WA AND WV.
Descripción del producto
Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. || Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the lead to the fascia or interspinous/supraspinous ligament.
Worldwide Distribution-- USA (nationwide) including PUERTO RICO and countries of AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, FINLAND,FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, and UNITED KINGDOM.
Descripción del producto
Eon Mini Neurostimulation (IPG) System Model 3788 || System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Software version 3.3 for Rapid Programmer devices, Model 3832. || Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting implantable pulse generators of the Eon, Genesis, and Renew family.
The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. || Product Usage: || Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.