For Sara, Faulty Medical Device Leads to Unnecessary, Invasive Surgery

May 24, 2012 | 10:45 am
Michael Halpern
Former Contributor

Along with Gwen, Elsa, and Henry, another UCS supporter shared his family’s experiences with unsafe drugs and medical devices: John M’s daughter, Sara, has had needless complications with medical devices in her heart.

Sara, 37, has two young daughters. She’s a registered nurse in DeKalb, IL, a small town in northern Illinois (home of Northern Illinois University, where my mom went to college. Go Huskies!). Her job and taking care of her two kids occupies the vast majority of her time.

“My wife and I are lucky that we live so close by,” said John. “We are able to see the grandchildren a lot. But believe me, they’re a handful.”

Unfortunately, Sara has a condition that led to several hospitalizations and ultimately to multiple surgeries, at least one of which could have been easily avoided had safe and effective medical devices been used to treat her.

An unknown condition

Throughout her childhood and into adulthood, Sara’s parents and doctors were concerned about her frequent fainting spells. The doctors couldn’t figure out why they were happening. One explanation was exercise induced asthma, but that didn’t quite fit all of her symptoms.  “It was very difficult seeing Sara suffer and not know what exactly was causing the problem,” said her father.

It was not until Sara was in her twenties that she was diagnosed with postural orthostatic tachycardia syndrome (POTS). The condition causes neural misfiring in the autonomic nervous system that makes Sara’s heart rate soar, resulting in a drop in blood pressure that causes her to lose consciousness.

The illustration, from the National Heart, Lung, and Blood Institute, shows the location of an implantable cardioverter defibrillator in the upper chest.

The illustration, from the National Heart, Lung, and Blood Institute, shows the location of an implantable cardioverter defibrillator in the upper chest.

In 2001, at age 26, Sara was hospitalized to facilitate a switch in drugs to control her pulse rate. While there, she went into cardiac arrest. After this incident, her doctor inserted an implantable Cardioverter Defibrilator/Pacemaker (ICD) to ensure that Sara would have a regular heartbeat and provide defibrillation to restore proper heart rhythm via electric shock in the event her heart stopped.

Sara was soon back to her job, and initially, the device worked. “My wife has seen the need for the device,” said John. “There have been times when Sara has been in serious trouble and the ICD has gone into effect.”

But three years later, Sara was informed by her physician that the FDA had issued a Class 1 recall (indicating a life threatening fault) affecting 70,000 implanted defibrillators manufactured by Guidant Corporation – including hers. The device had a faulty wiring design that could cause it to short circuit, resulting in a failure to deliver an electric shock if needed.

A dangerous defect

Earlier that year, a 21 year-old male patient had suffered a fatal heart attack due to a failure of the device. His death led to an investigation, which revealed that the manufacturer had first known of the faulty design in February 2002, but had not recalled the device or informed doctors or the FDA about the risk until 2005.

After the recall, Sara’s doctors recommended that the device be replaced. While Guidant would cover the cost of the device, Sara had to pay out-of-pocket for most of the pre-operation procedures as well as the surgery itself and the postoperative care.

chest xray showing pacemaker

A chest x-ray showing a pacemaker after implementation. Unnecessary surgeries can take a cummulative toll on the body. Source: OpenI/NIH

Had Sara or her doctors had more information, she could have received a safer device the first time around and been spared the need for a replacement surgery. But she did her best to stay optimistic.

“She took this all in stride,” said John. “She has her daughters to look after. They are her priority and she couldn’t afford to dwell on the matter.”

For five years, the new device worked as it was designed, and even kicked in a few times to stabilize her heart. But then, Sara heard a beeping noise which she realized was coming from inside her. The defibrillator’s battery was low and needed to be replaced. (According to the NIH, the batteries generally last between five and fifteen years, with an average of six to seven years).

About seven weeks ago, Sara underwent another operation, and this time, the wound became infected and has not fully healed.  She has yet to return to work.

Cumulative effects

John says that this most recent bout has been very difficult for her. She is on massive doses of antibiotics which have many side effects.  She is also in fear of losing her job because she cannot return to work until the infection is cleared up.

“When she has the time to think about what she’s going through, I think it’s paralyzing for her,” said her father. “And as a parent, it’s been heartbreaking to see her go through all of this.”

This is part of a series of posts on drug safety reform at FDA.

The use of implantable pacemakers and defibrillators has grown significantly in recent years. From 2000 to 2005, sales for the devices nearly doubled to $8 billion annually. But at the same time, recalls from manufacturers such as Guidant and Medtronic have raised concerns about the device approval and monitoring process.

Even routine surgeries are incredibly complex and have the possibility of unanticipated side effects. For the patient, every additional surgery presents risks and takes a cumulative toll on the body. “Having these invasive, serious operations, again and again, is starting to take a toll,” said John.

Sara’s continued complications have impacted her physical and mental health. We must do better to make sure that medical devices are safe—before they end up in patients.