Brief Statement: Model 5391 Single-Chamber Temporary Pacemaker

Intended Use

The Medtronic Model 5391 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 5391 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:

• treatment of patients before an operation, whereby an implantable pacemaker is being inserted
• treatment of tachyarrhythmia
• treatment of special cases of acute myocardial infarction
• treatment of patients after heart surgery

The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient.

Contraindications

There are no contraindications with regards to the use of the 5391 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.

Asynchronous pacing is contraindicated in the presence of intrinsic cardiac rhythms.

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.

Warnings/Precautions

Monitor the patient continuously while the temporary pacemaker is in use to ensure it is operating properly and delivering appropriate therapy to the patient. 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.

• Warning: The 5391 does not have pacing continuation when the 9 Volt battery is removed.
• Warning: The 5391 must not be connected to the patient during battery replacement.
• External Interference: The 5391 may be inhibited by strong external interference resembling the signal the pacer is designed to sense. Such interference signals may be produced by a variety of sources including electrocautery, diathermy, and other devices. The 5391 will not be damaged by such interferences and will resume its function as soon as the interference source is removed.
• Defibrillation equipment should be at hand while the 5391 and its leads are being introduced into and connected to the patient.
• Warning: MR unsafe - The temporary pacemaker is MR unsafe. Do not bring the temporary pacemaker into Zone 4 (magnet room), as defined by the American College of Radiology.

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 5391 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 5391 include, but are not limited to myocardial irritability resulting in fibrillation, infarction, pericarditis, rejection, muscle and never 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.  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.

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 this device to sale by or on the order of a physician.

Brief Statement: Temporary Pacemakers Model 5348 and Model 5388

Indications

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.

Contraindications

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.

Warnings/Precautions

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.

Potential Complications 

Brief Statement: Model 53401 Temporary External Pacemaker

Intended Use

The Medtronic Model 53401 Temporary External Pacemaker is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. 

Contraindications

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. Single chamber atrial pacing is contraindicated in the presence of AV conduction disorders.  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.

Warnings/Precautions

Brief Statement:  Medtronic Leads

Indications

Medtronic leads are used as part of a cardiac rhythm disease management system. Leads are intended for pacing and sensing and/or defibrillation. Defibrillation leads have application for patients for whom implantable cardioverter defibrillation is indicated

Contraindications

Medtronic leads are contraindicated for the following:

• ventricular use in patients with tricuspid valvular disease or a tricuspid mechanical heart valve.
• patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate or dexamethasone acetate may be contraindicated. (includes all leads which contain these steroids)
• Epicardial leads should not be used on patients with a heavily infarcted or fibrotic myocardium.

The SelectSecure Model 3830 Lead is also contraindicated for the following: 

• patients for whom a single dose of 40.µg of beclomethasone dipropionate may be contraindicated.
• patients with obstructed or inadequate vasculature for intravenous catheterization.

Warnings/Precautions

People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, or the need to reprogram or replace the device.

For the SelectSecure Model 3830 lead, total patient exposure to beclomethasone 17,21-dipropionate should be considered when implanting multiple leads.  No drug interactions with inhaled beclomethasone 17,21-dipropionate have been described. Drug interactions of beclomethasone 17,21-dipropionate with the Model 3830 lead have not been studied.

Potential Complications

Potential complications include, but are not limited to, valve damage, fibrillation and other arrhythmias, thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, muscle or nerve stimulation, pericardial rub, infection, myocardial irritability, and pneumothorax.   Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation or exit block.

See the device manual for detailed information regarding the implant 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 this device to sale by or on the order of a physician.