Precautions - Medtronic DBS 3387 Gebrauchsanweisung

Magnetic Resonance Imaging – Do not conduct an MRI examination on
a patient with any implanted Activa System component until you read and
fully understand all MRI information in this manual. Do not conduct an MRI
examination at parameters other than those described in this guideline.
Failure to follow all warnings and guidelines related to MRI can result in
serious and permanent injury including coma, paralysis, or death. Refer to
the MRI guidelines manual packaged with this product for comprehensive
safety information and instructions.
Patient Activities – Close proximity to high levels of electromagnetic
interference (EMI) may cause a neurostimulator to switch ON or OFF. The
system also may unexpectedly cease to function due to normal battery
depletion or other causes. For these reasons, the patient should be advised
about any hazardous activities that would be potentially unsafe if their
movement disorder unexpectedly returns.
Pediatric Use – Safety and effectiveness has not been established for
pediatric use.
Placement of Lead-Extension Connector – The safety and
effectiveness of neck placement of the connector between the lead and
extension has not been established and has been associated with an
increased incidence of lead fracture.
Pregnancy – Safety for use during pregnancy or delivery have not been
established.
Theft Detectors and Screening Devices – Theft detectors found in retail
stores, public libraries, etc., and airport/security screening devices may
cause the stimulation power source of an implantable neurostimulation
system to switch On or Off. It is also possible that sensitive patients, or
those with low stimulation thresholds, may experience a momentary
increase in their perceived stimulation. For other indications, higher levels
of stimulation have been described as uncomfortable ("jolting" or
"shocking") by some patients as they pass through these devices. Refer to
"Physician Instructions to Patient" on page 34 for more information.

Precautions

Storage and Sterilization
Resterilization Considerations – Refer to "Resterilization" on page 18
for further information.
Storage Temperature – Store the DBS Lead between –34 °C (0 °F) and
57 °C (135 °F). Temperatures outside this range can damage components.
System and Therapy
Component Failures – The physician should be aware that all
neurostimulation systems may unexpectedly cease to function. A system
may fail at any time due to random failures of the system components or
the battery (prior to normal depletion). These events, which can include
electrical short or open circuits and insulation breaches, cannot be
predicted.
Components – The use of non-Medtronic components with this system
may result in damage to Medtronic components, loss of stimulation, or
patient injury.
Technical Manual English 13