Medtronic Neurological
Country not established
- Devices
- 2
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Medtronic Neurological makes
Medtronic Neurological manufactures neurological leads and fixation anchors for deep brain stimulation and neuromodulation systems. The PISCES Z Quad series includes leads for targeted neural stimulation, such as the 3890, 3891, and 3892 models, designed for quadripolar electrode configurations. The GRIP LOCK ANCHOR (Model 411374) is a fixation device used to secure leads within the body.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Grip Lock Anchor, Model 411374 Ref K013063
Regimes: 510(k) Registry: 510(k)Pisces Z Quad Lead Model, 3890, Pisces Z Quad Compact Lead Model, 3891, Pisces Z Quad Plus Lead Model, 3892 Ref K033016
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 6 recalls initiated by Medtronic Neurological, the earliest on 2006-04-04 and the most recent on 2006-08-02. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 2 Aug 2006 Z-1536-06 Unclassified (pre-2012) Terminated Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot V009546 may contain a 3777 standard-spaced lead. The result of this error is an overall increase or decrease of 14 mm in the electrode coverage.
- 2 Aug 2006 Z-1537-06 Unclassified (pre-2012) Terminated Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot V009546 may contain a 3777 standard-spaced lead. The result of this error is an overall increase or decrease of 14 mm in the electrode coverage.
- 21 Jul 2006 Z-1414-06 Unclassified (pre-2012) Terminated Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation.
Full distribution text
- 21 Jul 2006 Z-1415-06 Unclassified (pre-2012) Terminated Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation.
Full distribution text
- 19 Jul 2006 Z-0290-2007 Unclassified (pre-2012) Terminated A subset of Kinetra implantable neurostimulators may experience a failure of wire connections between the electronic hybrid circuit and battery which may lead to sudden cessation of therapy. Sudden cessation of therapy can result in the immediate return or worsening of underlying symptoms due to the progression of the disease state.
Full distribution text
- 4 Apr 2006 Z-0861-06 Unclassified (pre-2012) Terminated A specific subset of model 7428 Kinetra implantable neurostimulators may fail due to lifted wirebonds between the hybrid circuit and battery. This failure mechanism may present clinically as loss of functionality and a return of the patient's underlying medical conditions.
Frequently asked questions
How many devices does Medtronic Neurological have in the registry?
The registry currently lists 2 devices for Medtronic Neurological. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Neurological's devices?
Among its 2 most recently registered devices, Medtronic Neurological has devices listed in FDA 510(k) (2 devices).
What risk classes do Medtronic Neurological's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Medtronic Neurological's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Medtronic Neurological?
FDA recall records list 6 recalls initiated by Medtronic Neurological, the most recent initiated on 2 Aug 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Medtronic Neurological in the registry?
The most recently registered devices listed for Medtronic Neurological include GRIP LOCK ANCHOR, MODEL 411374 and PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892.