Indications, Safety, and Warnings
Brief Statement: Temporary Pacemakers
Single-chamber temporary pacemakers are designed to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in the clinical environment. Dual-chamber temporary pacemakers are intended to be used in conjunction with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment. Temporary pacemakers can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes.
There are no known contraindications to the use of temporary pacing as a means to control the heart rate. The patient’s age and medical condition, however, may dictate the type of temporary pacemaker and lead system used by the physician. Pacing modes which allow sensing in the atrium to trigger a ventricular response are contraindicated in the presence of rapid atrial arrhythmias such as atrial fibrillation or atrial flutter. Atrial pacing is ineffective in the presence of atrial fibrillation or flutter. Single chamber atrial pacing is contraindicated in the presence of AV conduction disorders. Asynchronous pacing is contraindicated in the presence of intrinsic cardiac rhythms. High-rate burst therapy is intended for use in the atrium only. Use in the ventricle could result in life-threatening arrhythmias.
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. Extreme caution must be taken to properly ground all line-powered equipment used in the vicinity of the patient. 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.
The physician should be aware that the temporary pacemaker can fail due to a number of reasons such as random component failure, battery depletion, and mishandling. The pacing lead system may cease to function at any time due to improper connections or lead-related problems such as displacement or fracture. 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.
Complications related to the use of temporary pacemakers include, but are not limited to, asystole following abrupt cessation of pacing or inhibition or reversion of the pacemaker in the presence of strong electromagnetic interference. High-rate pacing may result in tachycardia acceleration of an existing tachycardia or fibrillation. Application of temporary high-rate pacing should be performed under careful patient monitoring and control. Potential complications related to the use of pacing lead systems with temporary pacemakers include, but are not limited to, disconnection of the lead system, lead fracture or displacement causing intermittent or complete loss of capture and/or sensing, or myocardial irritability resulting in fibrillation and the potential of pericarditis.
See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.