Medtronic Models 5348 and 5388 Care and Use
Find additional use and training information at www.MedtronicConnect.com
What to do ...
What NOT to do ...
Replace the battery for each new patient.
Do NOT reuse battery.
Check case for cracks/damage.*
Check battery drawer for closure.*
Check display for cracks/damage.*
Do NOT ignore physical damage; the device may appear to work properly
immediately after being dropped or mishandled, but operational damage may
Inspect cables and leads for possible defects, and secure connection
before each use.
Do NOT use damaged leads or cables. Improper connection, displacement, or
fracture may result in pacemaker failure.
Do NOT reuse single-use cables.
Place in an area that minimizes tampering by patient or unauthorized
personnel. If necessary, use plastic cover ** to protect against
unauthorized access to the controls.
Do NOT place the device in any area where the patient may interact with it.
External surfaces of unit can be cleaned using a sponge or cloth
moistened with water or 70% isopropyl alcohol. For internal surfaces,
send to Medtronic for cleaning, safety, and technical check.
Do NOT attempt to clean any internal surfaces, including battery compartment.
Do NOT immerse the device in water or cleaning agents; do NOT expose the
unit to ethers, acetone, or chlorinated solvents.
Send to Medtronic for safety and technical check.
Do Not ignore; the device may appear to work appropriately immediately after
being dropped or mishandled, but operational damage may have occurred.
If Spilled on
Send to Medtronic for safety and technical check.
Do Not ignore; the temporary pacemaker was designed to minimize leakage,
but fluid incursion may still occur.
* Should service or repair be necessary, contact your local Medtronic representative or call 1(800) 638-1991.
** Plastic cover available for the 5388 dual chamber temporary pacemaker; Model #5441
Safety and technical checks should be carried out at least once every 12 months and after any malfunction or accident. Visit www.MedtronicConnect.com or call 1(800) 638-1991 to
inquire further about the Medtronic Annual Test and Calibration Program.
Medtronic USA, Inc.
Toll-free: 1 (800) 328-2518
(24-hour technical support for
physicians and medical professionals)
710 Medtronic Parkway
Minneapolis, MN 55432-5604
Fax: (763) 514-4879
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 shortterm 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 that 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
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
UC200905853 EN © Medtronic, Inc. 2009. Minneapolis, MN. All Rights Reserved. Printed in USA. 05/2009