Medtronic Neurological

Model 3778, Lot V009546

Neurological Devices

3

Yes

Nationwide distribution --- including states of CA, GA, KY, LA, and TX.

Medtronic 3778 Lead Kit, 1x8 Compact Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.

Model 3777, Lot V009545

Neurological Devices

3

Yes

Nationwide distribution --- including states of CA, GA, KY, LA, and TX.

Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.

NFD621879S, NFD621891S, NFD621901S, NFD621981S, NFD621976S, NFD622170S, NFD622185S, NFD622189S, NFD622201S, NFD622247S, NFD622279S, NFD623035S, NFD622345S, NFD622349S, NFD622372S, NFD622382S, NFD622387S, NFD622400S, NFD622414S, NFD622466S,  NFD622542S, NFD622564S, NFD622629S, NFD622664S

Neurological Devices

3

Yes

USA--States of CA, OR, PA. Internationally -Belgium, France, Germany, Italy, Spain, Switzerland, United Kingdom

Medtronic Kinetra 7428. Dual Program Neurostimulator for Deep Brain Stimulation. Rx only. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. Kinetra neurostimulator is a component of the Activa System. The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The dual program Model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case.

serial numbers in the following ranges:   ¿ NFD100006 - NFD100325H ¿ NFD620017S - NFD625737S ¿ NFD200201K - NFD201303K

Neurological Devices

3

Yes

Worldwide, including USA, Puerto Rico, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Israel, Italy, Jordan, Lebanon, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.

Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The dual program model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via DBS extension or DBS leads. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case. The operation of the neurostimulator is supported by a clinician programmer, a therapy controller, and a control magnet.

Model 8598 Base Lot Numbers: B011468N, B011893N, B011894N, N0012129, N0012612, N0012969, N0012970, N0012971, N0014057, N0014058, N0014179, N0014180, N0016472.   *Model 8731 Catheters and model 8598 Distal Revision kits have a Base Lot number of eight (8) characters plus a two (2) digit suffix that represents serialization within these recalled lots. This list provides just the Base lot Number (the first eight characters of the product Lot No. found on the product labeling).

General Hospital and Personal Use Devices

3

Yes

Worldwide Distribution-USA and Austria, Belgium, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom

Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598, (provides replacement parts for the distal section of the 8731 Intrathecal Catheter) . Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.