Medtronic Single Chamber Temporary Pacemaker

Asynchronous pacing is contraindicated in the presence of intrinsic cardiac rhythms. Atrial high-rate burst pacing therapy is intended for use in the atrium only. High-rate burst pacing in the ventricle may result in life-threatening arrhythmias. The temporary pacemaker is MR Unsafe. ECG monitoring should be in use and defibrillating equipment should be placed on standby and be kept immediately available during pacing lead insertion, pulse generator connection and adjustment, measurements of stimulation thresholds or sensed potentials, and application of antitachycardia burst therapy.

Use of high rates in the atrium may result in accidental conduction to the ventricle. Defibrillation equipment should be kept immediately available during high-rate pacing. Operational failure of the temporary pacemaker can occur as the result of battery depletion, mishandling, or random component failure. Complications related to the use of temporary external pacemakers such as the Model include, but are not limited to, asystole following abrupt cessation of pacing, inhibition, and reversion.

Potential complications related to the use of pacing lead systems with the Model include, but are not limited to, myocardial irritability resulting in fibrillation, infarction, pericarditis, rejection, muscle and nerve stimulation, and infection. Complication related to inhibition or reversion of the pacemaker in the presence of strong electromagnetic interference. Whenever possible, for the safety of the patient, disconnect the temporary pacemaker from the implanted lead system before defibrillating or cardioverting.

Excessive defibrillation energy can damage the temporary pacemaker. This can result in a large current flowing through the implanted lead system and temporary pacemaker, which could reduce intended defibrillation energy delivered to the patient or cause myocardial damage. A lead with extension cable constitutes a direct, low-resistance current path to the myocardium. During connection and testing procedures, only battery-powered instrumentation should be used.

During connection and testing procedures, only battery-powered instrumentation should be used. Extreme caution must be taken to properly ground all line-powered equipment used in the vicinity of the patient. Electrosurgical units can cause tachyarrhythmias by inducing current on the leads. Improper connection, displacement or fracture of leads or cables may result in pacemaker system failure. Inspect leads and cables for damage before each use. The pacing lead system may cease to function at any time due to improper connections or lead-related problems such as displacement or fracture.

Do not modify the temporary pacemaker. Modifications could impact the temporary pacemaker effectiveness and adversely affect patient safety. Federal law USA restricts this device to sale by or on the order of a physician. Model Single-Chamber Temporary Pacemaker Intended Use The Medtronic Model Single-Chamber Temporary Pacemaker is intended to be used in conjunction with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment by trained personnel.

The external pacemaker is designed for temporary stimulation of the heart in case of rhythm disturbances and conduction defects. According to present clinical experience, the instrument is especially suited for stimulation of the heart in the following cases: Contraindications There are no contraindications with regards to the use of the for temporary cardiac stimulation for therapy and prevention of arrhythmia. The state of health of the patient, however, can restrict the choice of operational mode and stimulation parameters.

For example, a mode of operation with atrial sensing is not suitable or appropriate when atrial fibrillation occurs. This is due to the excessive and chaotic frequency of detected fibrillation waves. Overdrive-stimulation therapy must only be used in the atrium. Overdrive-stimulation in the ventricle could cause life threatening ventricular fibrillation. Medtronic does not recommend high-rate pacing for the treatment of ventricular tachycardia.

The does not have pacing continuation when the 9 Volt battery is removed. The must not be connected to the patient during battery replacement. The may be inhibited by strong external interference resembling the signal the pacer is designed to sense.

Brief Statement: Model 5392 Dual-Chamber Temporary Pacemaker