For Your Information.

• by Stepford_Wife
• 2007-11-02 01:11:59
• General Posting
• 1612 views
• 1 comments

To everyone affected by the Medtronic Sprint Fidelis lead recall.
It is very important that you read the following.

~ Dominique ~


Recall Information
HCMA ( Hypertrophic Cardiomyopathy Association ) responds to the Medtronic Sprint Fidelis lead recall October 2007
The HCMA fully supports the use of ICD’s in those at high risk for sudden cardiac arrest. Years of research and surveillance have proven this therapy to be safe and effective in HCM patients and, in fact, saved thousands of lives already. The recent recall of the Medtronic Sprint Fidelis lead has caused concern among many in the HCM community and rightfully so, this is a serious and complicated issue.
We will be conducting a conference call on Thursday November 1, 2007 at 2:00pm eastern time for patients and their families. A representative from Medtronic will be on the call to hear your concerns and address your questions. The media is not permitted to participate in this call. It will be an opportunity to discuss your concerns with other patients and also to learn about options you have and may need to discuss with your doctor in the coming weeks. To participate in this conference call you must call the HCMA office and obtain the call in number and password. Please call 973-9 83-7429 and ask for Kelly DeRosa who can assist you with this information. We anticipate that this will be the first in a series of calls as all of your questions and concerns may not have answers readily available.
This document contains information obtained from the Medtronic website,calls to Medtronic Technical Services, and data from St. Jude and Boston Scientific obtained from their Technical Services Departments. You may wish to bring this document to your physician for further discussion. It is our aim to provide those in the HCM community with appropriate information to make true informed consent as to how to proceed with their implantable medical devices. This document is broken into 3 sections. Section 1 contains the recommendations for re-programming and technical information your doctor has been provided by Medtronic. Section 2 contains frequently asked questions to the HCMA. Section 3 conta ins a patient check list created by Medtronic to help address the concerns of those with implantable device including how to know if you have a lead that is affected by this recall.
Section 1.
Recommendations obtained from the Medtronic website for medical professionals. (This information is how your doctor will proceed in programming your device, the only action required from the patient is to attend your ICD clinic appointment as scheduled by your doctors and ensure the settings have been adjusted based on the current recommendations – please note that these are the recommendations as of October 25, 2007 and may be subject to change if new data becomes available).
Medtronic recommends you consider the following as part of routine follow-up for each patient:

* To reduce the risk of inappropriate detection and therapy due to oversensing, program VF detection for initial Number of Intervals to Detect (NID) to nominal settings (18/24) or longer at physician discretion and Redetect NID to nominal settings (12/16).
* Turn ON Patient Alert™ for RV Pacing, RV Defibrillation, and SVC Defibrillation impedance. For Concerto® and Virtuoso® devices enrolled on the Medtronic CareLink™ Network, turn ON the CareLink CareAlert® notifications for these same parameters
* To optimize effectiveness of the lead impedance alert:
o Review V Pacing Lead Performance Trend to determine typical chronic impedance value for the patient (typical values for Fidelis leads should be 350-1,000 ohms).
o Program lead impedance alert threshold for RV Pacing to 1,000 ohms, if the typical chronic impedance for the patient is ? 700 ohms, or
o Program lead impedance alert threshold for RV Pacing to 1,500 ohms, if the typical chronic impedance for the patient is > 700 ohms.
o Program lead impedance alert threshold for RV Defibrillation and SVC Defibrillation to 100 ohms.

The patient management recommendations set forth above should increase the likelihood that a fracture will be detected by Patient Alert and/or Medtronic CareAlert notifications and decrease the likelihood of inappropriate therapies. Based on our review of the available data, there does not appear to be a benefit to more frequent follow-up.
Medtronic’s Independent Physician Quality Panel believes it is inappropriate to prophylactically remove Sprint Fidelis leads except in unusual individual patient circumstances. We support this position.
Lead extraction carries risks that should be considered in patient management. Published literature suggestsmajor complications (death or surgical intervention) from lead extraction range from 1.4-7.3%. As always, with confirmed lead failure the risk of extraction should be weighed against the risk of adding an additional lead.
Section 2.
The HCMA has been working closely with Medtronic to help ensure that patients have access to information about the lead, systems that are in place to answer your questions and steps to take with your doctor. In addition to information available on the Medtronic website the HCMA has collected some frequently asked questions that we thought you would find useful.
1. If I am pacemaker dependent does that change the recommendations given for monitoring?
If your doctor feels it is in your best interest to replace the lead due to concern of over sensing the lead may need to be removed or replaced. There is a system in place to assist in the administrative aspects of the replacement and a form your doctor needs to complete. There are 3 requirements for this type of replacement. 1. You must be pacer dependent 2. The doctor has considered the risks and benefits of leaving the lead active, removing the lead or adding a new lead. 3. The doctor deems it medically necessary to replace the lead. If you meet all three items you will receive a replacement lead and reimbursement for out of pocket medical expenses from Medtronic of up to $800.00
2. I have a Medtronic Sprint Fidelis lead that is on the recall list but I have a St. Jude or Boston Scientific (Guidant) generator/device, what should I do about the settings on my device? Is it the same as the setting on the Medtronic devices?
You will need to contact the manufacturer of the generator/device and ask them what the settings should be and communicate with your doctor to ensure everyone is working off the same information. Each device manufacturer and device operates differently. Additional information about Boston Scientific device programming is available by below. For information about St. Jude device programming is available below. To contact Boston Scientific call 1-800- CARDIAC or St. Jude at 1-800-328-9634.
3. In the event that my device fires and I am not sure if it was appropriate should I use a magnet to suspend therapy?
No. If your device fires more than once please contact Emergency Services (EMS) as soon as possible. Once you are on a cardiac monitor medical professionals can determine if a magnet can or should be used to suspend therapy.
Use of a magnet to suspend therapy can be very dangerous.
4. I had a Sprint Fidelis lead that failed and I have already had it replaced is there anything I can do to recoup my out of pocket medical expenses?
Yes, contact Medtronic Patient Services at 1-800- 551-5544 and they will provide you with the information you need to process your request.
5. In the event that my doctor recommends the lead be removed or replaced who will pay for the new lead and my medical expenses?
The leads are covered by a warranty and some of the costs associated with implanting and removing leads may also be covered in the warranty. In addition Medtronic is offering to pay up to $800.00 in unreimbursed medical expenses. Contact patient services for more information at 1-800- 551-5544
Section 3.
Patient Check List as listed on the Medtronic website:
How to find out if you have a Sprint Fidelis® lead (Models 6930, 6931, 6948, 6949):
Your Patient ID card should contain one of the following 4 sets of numbers: 6930, 6931, 6948, 6949. These numbers may be shown at the beginning of a longer set of numbers on your ID card.
What should you do, if you have a Sprint Fidelis lead:

* The chance there is a problem with your lead is small.

* If you have not already heard from your doctor’s office regarding this matter, we encourage you to contact your doctor’s office.

* You are more likely to experience complications from removal than from a problem with your Sprint Fidelis lead. However, your doctor may choose to change the way your device is programmed to help reduce any potential problems. An independent panel of physician experts recommends against replacing Sprint Fidelis leads except in very unusual circumstances.

If you experience any unexplained changes to your health or physical symptoms:
We encourage you to contact your doctor’s office.
Should you have questions about your implantable defibrillator or pacemaker device:
This information applies to the Sprint Fidelis lead only, not your implanted defibrillator or pacemaker device.
If you have additional questions:
Please contact Medtronic Patient Services at 1 (800) 551-5544 x41835.
Medtronic sinerely apologizes for any difficulties this may cause you and your family.