St. Jude recall

I was just notified by St. Jude at the request of my Doctor that my Fortify Unify Quadra CRT-D has been recalled due to a premature battery depletion.  Any of theses made prior to 2015 have been recalled. Mine was implanted January 2013.  It is a FDA Class 1 recall which is the most serious class.   My Doctor is advising all patients with this device to get a replacement.  St Jude agrees to pay up to $2500 of my deductible and provide a new device free of charge.  Is there anyone that has also received this recall notice? My surgery the first time was a nightmare and I am depressed and scared at the thought of another surgery and recovery. 

Tx58


8 Comments

Battery

by Tx58 - 2016-10-29 17:32:36

Thank you for your thoughts.  I have a Doctors Appointment in a week to discuss a replacement. 

Tx58

replacements

by Tracey_E - 2016-10-29 20:06:55

I'm so sorry you have a recalled device! So not fun. But know that replacements are nowhere near as complicated as the initial placement. Most of the soreness the first time was making the pocket, now it's scar tissue. Most of the restrictions the first time were new leads, no new leads this time. I'm on my 5th, after a replacement I'm usually home by noon and ready to get back to my regular schedule within a few days. Good luck.

St Jude Recall

by BillH - 2016-10-29 22:36:45

The problem with the STJ devices is that they can completely fail within a day or two, with out any warning. However, this apparently affects only a small percentage of devices.

Now you have a CRT-D that has two functions. One is the defibulator. If it fails then you have the risk of having an event and not defib. Depending on how much risk you condition poses and how much risk you are willing to accept then you can wait until the battery fails.

The other function is pacing/resysnc. Depending on how much you pace and how function you would be without the pacing again you might decide to wait and see if it dies.

A no to either one means that you should probably have it done ASAP.

 

St Jude CRT-D

by fishfighter - 2016-10-30 08:48:38

Yep, I have one on the recall list. My daughter saw the recall and told me. My doctor's didn't contact me, I contacted them. The last week, I been trying to get a phone call thru to St Jude, staying on the phone for hours at a time. I never got thru. I'm mad.Even my doctors office has tried with no luck. My Merlin at home monitor even stopped working.

I will have to make a two + hour trip just for the EP to get a reading. If it comes down to a replacement, I will NOT go with a St Jude.

I was told that the St Jude CRT-D battery will only last up to 5-6 years if one has three wires and paced 100% of the time. Yep, I have three, paced 100% of the time and it's been 5 1/2 in me. My doctors are at the point of panick to get me checked.

Battery

by Tx58 - 2016-10-30 10:15:01

I think the recall just came out on October 10th.  I received my letter a little over a week later.  My Doctors office asked them to send the letter.  The phone number on the letter is 1-866-915-5065.  I am not sure what number you are trying but maybe this one will work for you.  I pace 100% of the time. I have a left bundle block which requires that I pace 100% to synchronize my heart beat.  I also have cardiomyopathy which is why I have a defibrillator.  Also conjestive heart failure stage 2.  It use to be a 3 until I received my device.  My Doctor is not on the insurance plan I have so I will have to wait until next year when I can change my plan to include my Doctor along with a lower deductible and annual out of pocket maximum.  I rececently had an Echocardiogram and now have a small tear in my mitrovalve.  St Jude has a device that helps this condition so when I get mine changed out I will get the one that has this ability.  Glad to hear the replacement will go a lot easier than the initial surgery.  I had my pocket made deep so the device did not show.  I didn't want to be reminded about my condition every time I looked in the mirror.  This made my surgery more painful than it would have been if it was put in just under the skin.  My Doctor is recommending to all his patients with one of the recall devices, to have it replaced as soon as possible. I stopped using my monitor but will start it up again until next year when I have better insurance and can have the replacement done.  You must be so frustrated not being able to get through to St Jude and that drive to have your device checked is a long one.  I live in Houston and my Doctor is 15 min away and the hospital next to it.  I am worried by waiting but can't afford to do it now. If my battery goes out before my replacement I will be able to get emergency replacement.  My Doctor is well known and can get me taken care of quickly. My battery life for my three lead/defibrillator is 7 years. In August I was at 4 years. 

 

I wish you you the best in getting your situation taken care of quickly.  

 

Tx58

St. Jude Recall

by revcarol - 2016-11-08 22:47:29

Your condition really mirrors mine.  My defib fired 3 times last year in 1.5 mins.  The hospital could not get a St. Jude Rep to come and interrogate my device.  I was very unhappy with this performance.  

Now the recall... Mine looks to be about 7 year life, last read I had 1.7 in life... now this uncertain information.  

I am pretty certain I will not get another St. Jude... I am a VA patient and starting to not feel good about getting information from them.  Please keep me posted... Thanks and good luck.

St Jude recall

by Tx58 - 2016-11-09 15:45:10

St Jude is offering new free devices for six months and $2500 toward your deductible.  Additionally, they will pay up to $150 of your doctors visit to discuss the recall and if your condition warrants a new device.  I saw my Doctor Tuesday and we decided that I would have a Echocardiogram in February and discuss it again before the six months is up.  Mine has a 7 year life and I will be at for months in January 2017.  I have a monitor that picks up my activity at night which gets faxed to my Doctors office to read the following morning.   I had not been using it but turned it back on per the Doctors advice. The VA has a bad reputation in proving updated healthcare.   Can you afford to go to a cardiologist that is in private practice to discuss your condition and your options?

St Jude Recall

by cmorse724 - 2017-04-05 19:13:09

I had had have my devise replaced because of the recall. After many many phone calls to St Jude I finally got some answers. First of all when you contact St Jude go right to the Warrenty Departtment. I found out they will cover UP to 2500.00 in unpaid medical blls, the total cost of the devise and you can file a claim through the Claims Dept. for pain and suffering. I was told there was not a deadline to file but was later told I had only 2 weeks left to get my claim filed. I have had problems getting bills because St Jude took forever to send payment for the old devise. I now am down to a week left to flie.  As soon as I file my warrenty claim I can then file for the pain and suffering. Amount is not determined as I am supposed to figure out what I want to ask for. I am thinking AT Least 2000.00. Don't be afraid to push these people hard because they are wanting to get your claim over as easy as possible. I had my replacement surgery 1-13-2017. Had no problems and was healed in 3-4 weeks.

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