Heart Patient Fears for Her Life Living with Recalled St. Jude Pacemaker

November 1, 2017, 6:30PM. By Jane Mundy

Chino, CAWhen Marisa received an “Important Medical Device Advisory” letter from St. Jude Medical announcing that her implantable cardiac defibrillator may contain batteries that could run out sooner than expected, she was concerned, to say the least. Since she was 12 years old, Marisa, age 31, has depended upon a pacemaker to keep her alive.

The letter went on to say that “the likelihood that this will impact your health is low, as the vast majority of devices have not experienced Premature Battery Depletion”. Yet. Two deaths “may have been” associated with the faulty battery, but this statement was not reassuring. St. Jude announced the recall in October 2016 but Marisa didn’t find out until Christmas Eve, and only by getting the St. Jude letter forwarded by her doctor. She had to wait almost one year from the recall to get replacement surgery with another ICD-- a Medtronic device.

“I will never forget the feeling I had when I read that letter. This is a very scary situation for anybody and I thought I was going to die,” Marisa says. “I immediately called the phone number on the letter and they advised me to go to ER, which I did.”

Marisa, is used to hospitals. She was born with a heart condition and this recalled pacemaker is her third ICD. And she has three scars. “I gave the ER doctor the letter, they admitted me and called a St. Jude technician who came that night,” Marisa explains. “He updated my defibrillator, casually connected me to the machine, and said I would be OK for now. But I wasn’t buying it. He was cracking jokes about how he can control my heart! The doctor didn’t say anything—he was there for my heart—but my friend was shocked at his comments. And so was I. After the techie updated my device he told me to see my regular doctor within a few days, that I was in no danger right now and to go home.”

Of course, Marisa wanted her doctor to replace it, ASAP. But her doctor (who implanted her last two pacemakers) referred her to another surgeon and hospital because open-heart surgery and the risk of infection was too great. She was between a rock and a hard place.

“I tried to keep my mind busy, look after my six-year-old son and not focus on the danger—what could happen to my heart,” says Marisa. “It felt like I was in prison, in a situation where no one can help. The ICD is so easy to put in but so hard to remove.”

Marisa finally found a surgeon to replace the St. Jude ICD but she had to wait nine months, and not by choice. She wanted to preserve the device, to have the battery analyzed and determine if indeed it was defective. The surgeon at Loma Linda Hospital said he wouldn’t do the surgery if she wanted to keep the device and it wasn’t their job to preserve devices. She had to sign a form, and verbally agreed to do whatever was needed to have this surgery, which was done in September.

“I filed a claim because St Jude needs to take accountability for what they made,” says Marisa. “It took me nine months to get a replacement so imagine how long it would take for an elderly person to have it removed. I think there is a lot more going on than what they are revealing in this letter.” Marisa is hopeful that her story can bring awareness to the problem with this pacemaker and that doctors establish better communication with the pacemaker technicians. “And this St. Jude technician I had was seriously lacking bedside manner,” she adds, laughing. Seriously, Marisa’s St. Jude device was on their recall list. Imagine knowing for nine months that your life depends upon a faulty pacemaker…