Medtronic MiniMed 2007C Implantable Insulin Pump User Manual 1078 001
Medtronic MiniMed, Inc. Implantable Insulin Pump 1078 001
Contents
Manual
MiniMed® Implantable Pump System
REF MMT-2007C Implantable Pump Unit
** NOTE **
Please refer to the physician and patient manual for
instructions for use and detailed information regarding the
Medtronic MiniMed Implantable Pump System.
INTRODUCTION
The Medtronic MiniMed Implantable Pump System is a
sophisticated combination of technologies developed to
address the requirements of continuous intraperitoneal insulin
delivery for patients with Insulin Dependent Diabetes Mellitus
(IDDM). The system is comprised of: Implantable Pump,
Side Port Catheter, Personal Pump Communicator, and
accessory syringe, needle, template, and pipette. The pump
and catheter are designed for implantation. The Personal
Pump Communicator is designed to provide the patient a
variety of insulin delivery options. The accessory items are
specifically designed to facilitate refill of the implanted pump
and pump functions.
INDICATIONS FOR USE
The Medtronic MiniMed Implantable Pump System is
indicated for intraperitoneal administration of exogenous
insulin in patients with diabetes mellitus who are able to
actively participate in their treatment program.
CONTRAINDICATIONS
The MiniMed Implantable Pump System is contraindicated in
patients who:
• Are unwilling or unable to monitor their blood/glucose
level at least four times per day.
• Are unwilling or unable to make programming
modifications to the pump based on glucose level
readings.
• Are unable or unwilling to administer insulin by other
means if necessary.
• Are unable or unwilling to comply with the guidance and
advice of the treating physician and other healthcare
providers.
• Reside at or travel (other than by commercial aircraft) at
elevations above 8000 feet.
• Have other medical or mental conditions which may
place the patient at risk.
• Are unwilling or unable to return for routine insulin refill
(approx. 2-3 months) according to dosage.
• Present current or history of sensitivity to titanium alloy
or silicone materials used in the manufacture of system
implanted components.
PRECAUTIONS
Patients should always maintain conventional insulin supplies
in the event of pump and or Personal Pump Communicator
(PPC) failure. Delivery of insulin can become impaired due
to pump failure or catheter occlusion. In the event of
impaired insulin delivery, replacement of the pump or catheter
may be required. Physicians should review Physicians
Manual for full description of Pump replacement procedure
and catheter clearing procedures. The Medtronic MiniMed
Pump and Catheter Implants should NOT be used if damaged
prior to or during implantation procedures. The pump should
not be placed in contact with other metal implants.
WARNINGS
** NOTE **
The MMT-2007C pump can only be used with the
MMT 4021A-4028A Side Port Catheters
Physicians should be completely familiar with the function of
the pump, catheter, and personal pump communicator prior to
use of this device. Patients should be provided a complete
copy of the Patient Manual and have demonstrated the ability
to program the Personal Pump Communicator (PPC),
recognize and respond to safety alarms, and care of the
device prior to discharge.
The Medtronic MiniMed Implantable Pump System should not
be exposed to therapeutic ultrasound. Exposure to ultrasound
therapy may cause damage to the pump that may not be
apparent.
Only special-U400 insulins may be used in the Medtronic
MiniMed Implantable Pump System. Use of other insulin
types may cause damage to the pump mechanism resulting in
impaired insulin delivery or pump failure.
Any unauthorized changes or modifications made to any
component of the system may prevent effective use of that
and other components.
POSSIBLE ADVERSE EFFECTS
The Medtronic MiniMed Implantable Pump System has
undergone an extensive clinical evaluation. Evaluation of the
system spanned a period of ten years and involved over 600
subjects in the United States and Europe. Though over
delivery of insulin did not occur during the ten year evaluation
period, there is a potential for such occurrence. The
following are specific adverse effects which should be
understood by the physician and explained to the patient.
These do not include all adverse effects which can occur with
surgery in general or with the use of this devise, but are
important considerations particularly in the treatment of
people with diabetes. The general surgical risks as well as
operative site cosmetic risks should be explained to the
patient prior to surgery.
Abdominal Pain Foreign Body Reaction
Abnormal Healing Skin Disorder
Infection Urinary Disorder
Necrosis Psychiatric Decompensation
Retinal Disorder Skin Erosion
Abnormal Liver Function Kidney Disorder
Ileus Pocket Lymph Edema
Inflammation at Refill Site Pump Failure
Hyperglycemia Catheter Occlusion/
Hypoglycemia Encapsulation
Ketoacidosis Battery depletion
PPC Failure
STERILE DEVICE
The Medtronic MiniMed Implantable Pump is EO sterilized and
packaged sterile in tamper evident package. Do not use if
package has been opened or damaged.
PRESCRIPTION DEVICE
Caution: Federal (U.S.) law restricts this device to sale by or
on the order of a physician.
FCC Notice
This device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference and
(2) This device must accept any interference received,
including interference that may cause undesirable
operation.
CAUTION: Any changes or modifications not expressly
approved by Medtronic MiniMed could void your ability to
operate the equipment.
Medtronic MiniMed® 2007C
Implantable Pump System
Limited Warranty
The Medtronic MiniMed 2007 Implantable Pump and Personal Pump
Communicator are components of the Medtronic MiniMed Implantable
Pump System designed for the long-term, intraperitoneal infusion of
insulin in the intensive treatment of insulin dependent diabetes
mellitus (IDDM) with the use of a peritoneal catheter, also a
component of the system. Pumps include an exhaustible power
source which will ultimately cease to function, requiring replacement
of the entire pump. No representation is made regarding the longevity
of the power supply. Causes of pump or catheter failure include but
are not limited to: premature battery failure; changes in product
performance characteristics; medical complications; catheter
occlusion. The improper handling or filling of pumps, the use of drugs
other than special U-400, or other intervening acts may also result in
pump or catheter failure, despite all due care in design, manufacture
and testing prior to sale. Therefore, no representation or warranty is
made that cessation of pump or catheter function will not occur.
Moreover, because the implantation of any device is always subject to
inherent risks, no representation can be made that the human body
will not react adversely to the implantation or presence of the pump
and/or catheter.
Medtronic MiniMed hereby warrants solely to the original purchaser of
the Pump and Personal Pump Communicator the following:
1. Should the pump fail to function within normal tolerances due to
a defect in materials or workmanship within a period of six (6) years,
commencing with the date of the implant of the pump, Medtronic
MiniMed will issue a credit equal to the percentage purchase price, as
defined below, against the purchase of another pump requested as
its replacement, or, at the option of Medtronic MiniMed, provide a
replacement pump at no charge. The percentage shall be 100% for
pumps that fail within four (4) years of implant. The percentage shall
be reduced by either (i) 4% for each month beyond the forty-eighth
month that the pump functions within normal tolerances, or (ii) 1% for
each 1 ml of medication delivered beyond 200 ml of medication,
whichever percentage is greater.
2. The credit issued hereunder shall be provided to purchaser of
the replacement pump. As used herein, “Purchase Price” shall mean
the lesser of the original or replacement pump purchase price, as
evidenced by the Medtronic MiniMed invoice, or the purchase price of
the currently functionally comparable Medtronic MiniMed pump. In no
way shall the Purchase Price include any VAT, sales or other tax paid
in relation to the pump.
3. To qualify for this limited warranty, the pump must be implanted
before its “use before” date contained in its packaging; replaced
pumps must be returned to Medtronic MiniMed and shall be the sole
property of Medtronic MiniMed and the use of the pump, including the
medication infused thereby, must be in accordance with the manuals
shipped with the pump. All explanted pumps returned to Medtronic
MiniMed must be prepared and shipped in the manner described in
the Physician Manual. Proper preservation of the pump is required
for accurate post-implant analysis.
4. Should the Personal Pump Communicator fail to function within
normal tolerances due to a defect in materials or workmanship within
a period of three (3) years, commencing with the date of implant,
Medtronic MiniMed will either repair or replace the Personal Pump
Communicator, at the sole discretion of Medtronic MiniMed. For
Personal Pump Communicators that have been damaged as a result
of abuse or neglect, the owner will be charged for repair or
replacement.
The Limited Warranty is limited by its express terms. THE
REMEDIES PROVIDED FOR IN THIS WARRANTY ARE THE
EXCLUSIVE REMEDIES AND THIS WARRANTY IS EXPRESSLY IN
LIEU OF ALL OTHER WARRANTIES. NEITHER MEDTRONIC
MINIMED NOR ITS SUPPLIERS OR DISTRIBUTORS SHALL BE
LIABLE FOR ANY GENERAL, SPECIAL PUNITIVE OR
CONSEQUENTIAL DAMAGES ARISING OUT OF THE SALE,
MANUFACTURE OR USE OF THE PRODUCT SOLD
HEREUNDER. MEDTRONIC MINIMED MAKES NO WARRANTIES,
EXPRESS OR IMPLIED (INCUDING, BUT NOT LIMITED TO, ANY
WARRANTY OF MERCHANTIBILITY OR FITNESS OF THE
PRODUCTS FOR ANY PURPOSE OR REASON) WITH RESPECT
TO THE PUMP SOLD UNDER THIS WARRANTY, EXCEPT AS
CONTAINED IN THIS LIMITED WARRANTY. NO PERSON HAS ANY
AUTHORITY TO BIND MEDTRONIC MINIMED TO ANY
REPRESENTATION, CONDITION OR WARRANTY, EXCEPT AS
SPECIFICALLY SET FORTH HEREIN.
In no event shall this Limited Warranty apply to any Pump or Personal
Pump Communicator replaced after the end of the period specified in
Paragraphs 1 and 4 above. This Limited Warranty is not applicable to
catheters, side ports or other accessories used with the Pump.
Some jurisdictions do not allow the exclusion or limitation of incidental
or consequential damages, so the limitations or exclusions herein
may not apply. This Limited Warranty gives you specific legal rights,
and you may have other rights which vary from jurisdiction to
jurisdiction.
Products covered by the Warranty include:
MMT-2007C Implantable Pump
MMT-3150 Personal Pump Communicator
USA
Northridge, CA
(818) 362-5859
To order supplies
(818) 843-6687 • FAX (818) 364-0968
EUROPE
Medtronic MiniMed S.A.
63, Rue Marius Autan
92300 Levallois-Perret, France
Tel: (33)-(01)-47-59-76-60
FAX (33)-(01)-47-59-76-77
www.minimed.com
These products are covered by one or more of the following U.S.
patents:
[U.S.]4,373,527; [U.S.]4,395,259; [U.S.]4,525,165;
[U.S.]4,568,250; [U.S.]4,569,641; [U.S.]4,573,994;
[U.S.]4,619,653; [U.S.]4,636,150; [U.S.]4,731,051;
[U.S.]4,776,842; [U.S.]5,167,633; [U.S.]5,176,644;
[U.S.]5,197,322; [U.S.]5,217,442; [U.S.]5,257,971;
[U.S.]5,460,618; [U.S.]5,466,218; [U.S.]5,514,103;
[U.S.]5,527,307; [U.S.]5,559,828; [U.S.]5,797,733;
[U.S.]5,915,929
Patents also exist in a number of foreign countries and other U.S.,
international, and foreign patent applications are pending.
SYMBOL
MEANING
DO NOT RE-USE
READ INSTRUCTIONS FOR USE
STERILIZED WITH ETHYLENE OXIDE
REF
REFERENCE/RECORD NUMBER
STORAGE TEMPERATURE RANGE
FRAGILE PRODUCT
0459
MARKING AUTHORIZED
TYPE CF
OPEN HERE
07/01 6021029-001