Need to have upper lead replaced

I have a Guident 2 lead PM, implated in October 2007. Everything had been going very well, until a month ago when I started getting a slight fluttery feeling in my chest with an irregular heart rate. I went to the PM clinic to have it interogated. They told me that nothing was in the event recorder, but that I had over 1200 PACs since my last interogation. They called an EP in to look at the readings, he and the Guident tech were talking, saying something about the impedence being high on one of the leads, when the EP turns to me and asks "Did anyone ever tell you that on of you leads is not working?" I said no, no one ever had, in fact I had been told at my last interogation that I was pacing 100% on the lower lead and 2% on the upper lead. He told me that the upper lead was not working and that it was either not making good contact with the heart wall or was fractured and that, while I did not need it a present, it should be replaced now while it's still a relatively new implant, as it would be easier to do it now than at some (hopefully) distant future time when I do need it. I am now scheduled to have it replaced on August 4th.
After I left the office, and recovered somewhat from the shock, I remembered 2 things that happened just after I had the PM implanted that have me a little distrubed. On the morning after the surgery, the Guident tech came in and told me that they were turning down the upper lead to "conserve the battery". When I saw that dr who implated it later that week for my post op checkup (he has since left the practice), he said, in a very offhanded way as we were walking out to the desk, that the upper lead had been turned off to conserve battery life, and that I shouldn't be concerned about it. Am I being paranoid? because this is now sounding to me like the dr knew that there was a problem with the lead from day 1 and did nothing to correct it and WORSE did not even tell me that there was a problem with the lead.
I have also visited my cardio and he put me on Toporol for the PAC's, which does seem to be working, though he said that if the lead were loose, it could be irritating the wall of the atrium which could be causing the PAC's. He also called the Guident tech to get copies of all the interogations I've had to see when the problem may have occured. I see him Thursday and hope he tells me that I am being paranoid.
I have seen that others on here have had their leads replaced and wanted to ask if the recovery time is any longer or shorter than with the implant, guess the initial restrictions are the same, so I'm hoping it's no worse.
Sorry this has rambled a little, guess I just had to get it off my chest.

Donna

4 Comments

Second opinion...

by dward - 2008-07-16 05:07:53

get one!

Deja Vu

by CanadianKirk2 - 2008-07-16 11:07:09

I also have a Guidant 1291 pacemaker. Mine was implanted in November 2007. The implantation was done by a doctor who has some surgical training but is not a surgeon or EP...I didn't have a choice at the time. I found out from this doctor nine days later at what I thought was to be a routine post surgery checkup that my atrial lead had displaced. I, too, was in a state of shock when I got this news. When I went to the pacemaker clinic for my first visit to have my pacemaker adjusted, I found out from the technician that the lead had been turned off on day one after the surgery. The doctor must have known even before I left the hospital that there was a problem but didn’t inform me. I still to this day do not know how this shutoff was accomplished without my knowledge. Needless to say I felt deceived by this doctor and have never been back to his office. I eventually saw an EP at the nearest teaching hospital but it was decided that, in my particular case, lead removal was not worth the risk of infection. I was also told that I would not have had a choice in the matter if the lead had had a corkscrew tip. My pm is now set so that it only paces if my heart rate goes below 30. Since this adjustment there has been very little pacing going on.

I agree with the above member that it would be wise to check into the status of your pacemaker and leads. Most likely they were manufactured after the recall as mine were but it would be best if you checked just to be sure. Apparently some continued to be implanted when they should have been sent back to the manufacturer or disposed of. If you follow this link
http://www.bostonscientific.com/webapp/emarketing/lookup.jsp
you will come to a device lookup tool that you can use to tell whether your pm/leads were part of the recall or were manufactured after the recall. You will need to type into the tool search box the registration numbers for the pm and each of the two leads. You will find this information on the card you were given at the time of implant.

Good luck on your lead removal.

Your Guidant PM.

by Stepford_Wife - 2008-07-16 11:07:18

Hi Donna.

Have you checked to see if your pacemaker is one of the models recalled?
Although it is a very new implant, I understand that the recalled models may still be implanted.
Here is something you can read, F-Y-I.

~ Dominique ~

FOR IMMEDIATE RELEASE
P05-46
July 22, 2005


Media Inquiries:
Julie Zawisza, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Announces Guidant’s Class I Pacemaker Recall

The U.S. Food and Drug Administration (FDA) is notifying health care providers and patients that Guidant Corporation is voluntarily recalling certain pacemakers. A seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.

Only the following models are affected by this recall. All were manufactured between November 25, 1997 and October 26, 2000.

* PULSAR® MAX Models 1170, 1171, 1270
* PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
* DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
* MERIDIAN® Models 0476, 0976, 1176, 1276
* PULSAR MAX II Models 1180, 1181, 1280
* DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
* CONTAK TR® Model 1241
* VIRTUS PLUS® II* Models 1380, 1480
* INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

* VIRTUS PLUS II and INTELIS II models available only outside the U.S.

Guidant announced the initiation of a voluntary recall on July 18, 2005. The recall action consisted of a letter to physicians that describes the problem and provides recommendations about how to minimize the risk of pacemaker failure.

The FDA has classified Guidant's action as a Class I recall. Recall classifications can fall into one of three categories, with Class I being the most serious. These numerical classifications are based on the probability that the device failure could lead to adverse health effects. In a Class I recall, there is a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.

"Pacemakers are complex medical devices that can extend and improve the lives of many people who have heart rate abnormalities. However, they are not perfect and can malfunction," said Daniel Schultz, M.D., Director, FDA's Center for Devices and Radiological Health. "We are notifying patients and physicians about this important safety matter so they can take prompt action to reduce the risk of serious health consequences."

Some patients are very dependent on pacemakers to maintain an adequate heart rate. For these patients, failure of the device to provide pacing output can cause sudden faintness or loss of consciousness, and can result in death. The leakage defect can also cause a sustained rapid heart rate, which can cause heart failure and result in death.

While the failures can occur without warning, sometimes a leak-related malfunction can be detected by a physician before the malfunction causes serious problems. Guidant has provided information to physicians about ways to identify a leak-related malfunction. However, Guidant is not aware of any test that will show if a normally functioning pacemaker is likely to fail in the future.

As of July 11, 2005, Guidant had received reports that 69 pacemakers may have failed because of the leakage. Twenty of the devices were confirmed to have stopped providing pacing output, resulting in loss of consciousness in five patients. Guidant also received reports of two patients who had sustained pacing at a rapid rate. A patient whose device exhibited sustained pacing at a rapid rate was admitted to the hospital and later died. The device problem could not be confirmed as leakage since the device was not returned.

Approximately 18,000 of the affected devices remain in service in the United States and an additional 10,000 are in service in other countries. Guidant estimates that the failure rate from the leakage defect will be between 0.17% and 0.51% (i.e., between 1.7 per one thousand and 5.1 per one thousand) over the remaining lifetime of the devices. It is possible that the actual failure rate will be greater than this, in part, because some past failures may not have been reported to Guidant.

The FDA is not making a recommendation about whether a patient who has one of the Guidant pacemakers affected by this recall should have it replaced. This is a decision that should be made by the patient in consultation with his or her physician, based on the patient's history and medical condition. Removal and replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision.

The FDA concurs with Guidant's proposed recommendation to patients, which are consistent with the physician recommendations previously set forth in Guidant's July 18 letter:

* If you believe you are pacemaker dependent, contact your physician soon to discuss your treatment options.
* Continue your normal doctor appointments.
* If you experience symptoms of shortness of breath, dizziness, lightheadedness, loss of consciousness, or a prolonged fast heart rate, you should consult with your physician or go to the emergency room immediately.
* If you are not sure which model you have, or if you have other questions regarding your device, you should consult with your physician.
* If you know your device's model and serial number and want to find out if it is affected by the leakage problem, you can check www.guidant.com/webapp/emarketing/lookup.jsp or contact Guidant Technical Services at 1-866-GUIDANT (1-866-484-3268).

If you are a physician or a patient who has experienced a problem with any of these pacemakers, please send a report to FDA's MedWatch program and to Guidant. See http://www.fda.gov/medwatch/ for filing information or call 1-800-FDA-1088 (1-800-332-1088).

Guidant has posted information for physicians on its web site at www.guidant.com. Information for patients will be posted soon. If you have further questions, you may contact Guidant at 1-866-GUIDANT (1-866-484-3268).

####

Guidant Press Release (July 18, 2005)

LATE ENOUGH

by pete - 2008-07-17 03:07:56

BY 2007 the problems were well documented and it would have been extremely unlikely that they would have fitted one of the suspect pacemakers and or a faulty lead. I do think you are right that the doctor knew that you had a problem right from the start. Unfortunately doctors only tell you what they want you to know. You could argue that he did not lie to you but it could hardly be said that he told the "whole truth".
You are quite right to keep away from him. I know many doctors but I only know one doctor who I have not found fault with. The others I know are good at times and or good at certain things. Unfortunately we put ourselves in their hands, in good faith and find out later if they are not quite as good as we hoped. However we must realise that doctors are under stress and are only human after all. Their are all sort of pressures they are under , mental, financial, time/workload etc. Its just bad luck if it happens to effect us directly.
The important thing now is to put this behind you, and make 100% sure this problem is sorted. Leave no stone unturned. Wishing good health and good luck. Cheers pete

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