Download Consent to Implantable Devices

PLACE LABEL HERE
CONSENT TO IMPLANTABLE DEVICES
Important: Do not sign this form without reading and understanding its contents.
The diagnosis requiring this procedure: _______________________________________________
Procedure Date: ____________ Time: _________
(1)
General Information about Implantable Devices: These devices are implanted to treat heart rhythm
problems. These procedures are conducted under local anesthesia. A brief description of these
procedures with their indications follows.
(2)
Authorization.
I hereby authorize ________________________ and any such assistants and
designees as may be selected by him/her to perform the following procedure(s).

Biventricular Pacemaker
A device implanted to help treat the symptoms of congestive heart failure. It involves the insertion of
pacing wires into both right and left sides of the heart.
Permanent Pacemaker
A device implanted for treatment of slow heart rates. It involves inserting pacing wires into the heart via
veins and placement of a pacemaker device into a pocket in the chest.
Implantable Cardioverter / Defibrillator
A device implanted for treatment of rhythm disturbances. It involves the placement of leads/patches into
the heart via veins and possibly through the chest and the placement of the device into a pocket in the
chest or upper abdomen.
Implantable Loop Recorder
A device implanted to continuously monitor your heart’s electrical activity. It involves inserting a
small medical device (smaller than a pack of gum) under the skin in the upper chest.
Pacemaker Generator Removal
Removal of the pulse generator from within the surgically created pocket
Laser Lead Extraction
Removal of one or more leads inside the heart using laser technology
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Known Significant Risks of These Procedures
A.
B.
C.
D.
E.
Bleeding / Dissection (tearing of an artery or vein)
Occasionally the incision site will ooze resulting in a hematoma or bruise. Severe bleeding which
requires blood replacement (with associated risks of AIDS and/or hepatitis) or surgery is extremely rare.
Precautions are taken to minimize this risk but can occur despite these precautions.
Infection
The procedure is performed using sterile technique. The rate of infection is less than 1%.
Heart Attack and Stroke
Rare complications resulting from spasm or occlusion of the artery or arteries which supply the brain.
Allergic Reaction
Most reactions are to the iodine based contrast media and are minor. If you have had a previous
reaction to “dye” or contrast or are allergic to seafood notify the physician so that we may attempt to
avoid a reaction by premedication.
Rhythm Problems
The Lab is well equipped to deal with the rare, serious rhythm disturbances.
*3-21610*
FORM 3-21610 REV. 04/2016
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PLACE LABEL HERE
CONSENT TO IMPLANTABLE DEVICES
F.
G.
H.
I.
J.
K.
Death
Occurs in less than 1 out of 1,000 procedures.
Catheter Break
Occurs very rarely but may necessitate surgical removal.
Pneumothorax
Punctured lung. A rare, but possible complication.
Other medical risks generally recognized and accepted by reasonable prudent physicians are loss or
loss of function of any limb or organ, paralysis or partial paralysis, paraplegia or quadriplegia, disfiguring
scar, brain damage or cardiac arrest.
Emergent surgical repair
Occurs rarely but may necessitate emergent open heart surgery to repair tear of superior vena cava.
In addition to the above risks there may be other risks involved in this particular procedure such as:
_______________________________________________________________________________
(3)
It has been explained to me that during the course of the procedure, unforeseen conditions may arise
that require an extension of the original procedure(s) or different procedure(s) from that set forth in
Paragraph 2. I, therefore, authorize and request that the above named physician, his/her assistant or
designees, perform such procedures as appear necessary and desirable in their exercise of professional
judgment. The authority granted under this Paragraph 4 shall extend to treating all conditions that
require treatment and are not known at the time the procedure is commenced.
I acknowledge and understand that this request for any consent to surgical or diagnostic services shall
be valid for the responsible physician, all medical personnel under the direct supervision and control of
the responsible physician, and for all other medical personnel otherwise involved in the course of
treatment.
(4)
I acknowledge and understand that, in addition to the material risks of the procedure(s) listed in
Paragraph 3 there may be other risks attendant to the performance of the procedure(s) as there are with
any surgical or diagnostic procedure.
(5)
The likelihood of success of the above procedure has been discussed.
 Yes
 No
(6)
Practical alternatives to this procedure have been discussed.
 Yes
 No
Comments:
___________________________________________________________________________________
___________________________________________________________________________________
(7)
If I choose not to have the above procedure, my prognosis will be:
 Good
 Poor
 Fair
 Unknown
Comments:
___________________________________________________________________________________
___________________________________________________________________________________
FORM 3-21610 REV. 04/2016
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PLACE LABEL HERE
CONSENT TO IMPLANTABLE DEVICES
 Yes
 No
 NA
(8)
I am, or have reason to suspect, I am pregnant.
(9)
I am aware that the practice of medicine and surgery is not an exact science, and I acknowledge that no
guarantees have been made to me concerning the results of the procedure.
(10) I understand that the cardiologist performing my procedure is not an agent or an employee of Gwinnett
Medical Center, but is an independent medical practitioner exercising independent medical judgment at
facilities provided by Gwinnett Health System.
(11) I consent to the administration of anesthesia by my physician and to the use of such anesthetics as may
be deemed advisable. I consent to the use of a direct arterial, central venous, or pulmonary artery
catheters if my condition, or the nature of the procedure, necessitates such.
(12) I have been given ample opportunity to ask questions and any questions I have asked have been
answered or explained in a satisfactory manner.
(13) I acknowledge and understand that the explanation which I have received may not be exhaustive and all
inclusive and that other more remote risks may be involved. However, the information which I had
received is sufficient for me to authorize and consent to the procedure.
(14) Moderate Sedation. I understand that moderate sedation is the administration of a drug or drugs that will
depress consciousness during a surgical/diagnostic procedure. The risks of moderate sedation including,
but not limited to, heart attack and cessation of breathing, also have been explained to me, as have the
alternatives to moderate sedation, which are the administration of local anesthetics, oral pain medications
or no sedation at all.
By signing this form I understand the above information regarding cardiovascular tests/procedures
and acknowledge that I have been fully informed of the risks and possible complications. If any
unforeseen condition arises during the procedure calling for additional procedures, operations, or
medication (including anesthesia and blood transfusions), I further request and authorize the
physician to do whatever he/she deems advisable in my interest.
Signature of Person Giving Consent
Relationship to patient if not the patient
Patient unable to sign because:
Responsible Practitioner’s Statement:
I have reviewed the contents of this form, including the risks, benefits and alternatives to the proposed
procedure, with the patient or the patient’s decision-maker, and have provided the patient/decision-maker with
an opportunity to ask questions.
_________________________________________
Responsible Practitioner
FORM 3-21610 REV. 04/2016
________________________________________
Date/Time
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