Do Heart Devices Increase Patient Risk?
November 5, 2021
Surgeons have been implanting heart devices in patients for more than 50 years. However, patients are often unaware that there are many risks associated with this type of surgery. In addition to the risk of infection, patients may suffer harm if the surgeon implants a device improperly or if the device itself is defective.
There have been millions of reports of malfunctioning heart devices worldwide. Patients should know that they have the right to seek recovery of damages if they have been harmed by a defective heart device or by doctors who have not delivered proper treatment.
What Types of Heart Devices Pose Risks to Patients?
The types of heart devices that pose risks to patients include but are not limited to the following:
- Pacemakers: A basic pacemaker is designed to treat bradycardia, which means a slow heartbeat. The pacemaker transmits an electric pulse to the upper and/or lower heart muscles if it senses that a patient’s heartbeat is slowing down. The device is comprised of a pulse generator that generates the electrical current and one or two leads (electrodes) that transmit the pulse.
- Cardiac resynchronization therapy pacemakers (CRT-Ps): These are specialized pacemakers that also keep the blood pumping more efficiently by sending electrical impulses to the left and right ventricles of the heart.
- Cardiac resynchronization therapy defibrillator (CRT-Ds): Similar to CRT-Ps, these devices synchronize the heartbeat but also include a built-in defibrillator that deliver a shock to the heart if they detect heart arrhythmias that can otherwise lead to sudden death.
- Implantable cardioverter defibrillators (ICDs): These devices send an electric shock to the heart muscle if the patient experiences a life-threatening arrhythmia. It is different from a CRT-D because it lacks the second electrode that synchronizes the heartbeat.
- Coronary stent: This is a very small tube made from wire mesh that props open an artery during angioplasty surgery.
- Ventricular assist device (VAD): Also known as a heart pump, these devices help pump blood to the lower chambers of the heart (ventricles).
The implantation of heart devices creates risks of infection, excessive bleeding, and allergic reactions to the device material. In many cases, complications due to infection or allergic reactions cannot be avoided. However, there are many instances in which device malfunction or negligence on the part of physicians result in patients experiencing otherwise preventable injuries.
How Have Patients Been Unnecessarily Harmed by Faulty Heart Devices?
Faulty heart devices have unnecessarily harmed patients in the following ways:
- Patients failed to receive the electrical pulses to keep their hearts in rhythm because of a device battery failure.
- Patients received jolting electric shocks at the wrong time because the device leads malfunctioned.
- Patients were forced to undergo additional surgery because the implanted devices were recalled due to defects.
- Children or teenagers whose hearts did not respond properly because the implanted devices were not designed for their specific needs.
Heart device recalls are not uncommon. A study found in the National Library of Medicine, an institute within the National Institutes of Health, revealed that more than 103 different types of heart devices were recalled for defects during a 10-year period. More than 65 serious injuries were proven to be due to these defective devices, with at least 15 fatalities. Countless other patients endured psychological and emotional stress knowing that a recalled heart device was implanted in their body.
What Types of Heart Devices Have Been Recalled?
According to the study, more than 40 percent of heart devices recalled devices have been ICDs, 14 percent were pacemakers, 14 percent were stents, and the rest were CRTs or leads. One-third of the devices were recalled for battery malfunction, and another third were recalled because they failed to deliver electric shock therapy properly. The types of malfunctions included but were not limited to the following:
- ICDs delivering random shocks due to defective leads.
- ICDs failing to deliver electric pulses when needed due to faulty batteries, especially those implanted in active children and young adults.
- Pacemaker batteries died sooner than expected.
The study confirmed that ICDs generally tended to have a higher mechanical failure rate than pacemakers due to their thickness and complexity of their leads. The wires were prone to breaking, causing them to shock inappropriately or fail to defibrillate when the patient went into cardiac arrest. Other problems included loose screws or insulation breakdown, causing the device to fail to detect abnormal heartbeats.
Overall, studies indicate that problems with ICDs in particular are widespread. About 15 percent of patients with implanted ICDs have reported problems with their leads. An addition 10 percent of ICD patients who get a battery replacement discovered that they undetected lead failures.
What Are the Symptoms of Heart Device Malfunction?
Some patients are not aware that their heart device has malfunctioned until they undergo a replacement for a new battery. Symptoms of heart device malfunction include heart palpitations, dizziness, and infection. Infection occurs in up to eight percent of ICD patients, indicated by fever, chills, and redness near the site of the implanted device. The worst cases of infection may develop into sepsis, which can be fatal.
What Is the FDA’s Role in Recalling Faulty Devices?
The Federal Drug Administration (FDA) is responsible for approving medical devices before they go on the market. The FDA has been criticized in some cases for approving devices too quickly or giving medical device manufacturers exemptions for devices that are suspected to cause harm.
Between 2005 and 2007, the FDA received more than 50,000 reports of device malfunction involving an ICD called Sprint Fidelis. The malfunction caused the device to send electric shocks when they were not necessary and, in some cases, they failed to fire. Despite evidence that the leads on the device tended to fracture at a much higher rate than other ICDs, Sprint Fidelis remained on the market for a number of months before the manufacturer recalled the product, affecting more than a quarter of a million patients. After the recall, the FDA granted the device manufacturer an exemption and the device continued to be in use.
Most recently, in 2019, the FDA issued a letter to cardiologists regarding the Impella RP System due to a higher mortality rate than what was observed in clinical studies. The device has not been recalled.
How Can a Medical Malpractice Lawyer Help Patients Injured by a Faulty Heart Device?
A lawyer can help patients injured by a fault heart device by determining whether they have grounds for filing a medical malpractice or products liability lawsuit. In most cases, surgeries involving pacemakers and other heart devices are successful and help keep patients alive. However, there are times when the implanted devices are defective or medical professionals are negligent:
- Products liability: Medical device manufacturers are responsible for providing implants that are safe and durable and which will perform as expected. Patients who are harmed by faulty devices have a right to cover damages if they can prove that the defect caused an injury resulting in financial costs.
- Medical malpractice: Health care providers are responsible for delivering a standard of care equivalent to that provided by professionals with similar education and in comparable circumstances.
If a heart device was implanted improperly, that may be considered a departure from the standard of care.
If the patient has adverse symptoms after surgery and the physician did not recognize and treat those symptoms that may violate the standard of care.
If a patient suffered injury due to a faulty device, the surgeon may also be deemed negligent because doctors have an obligation to avoid implanting defective devices in their patients.
Proving negligence on the part of the heart device manufacturers or medical professionals requires legal experience and investigative skill. We have successfully obtained numerous complex products liability and medical malpractice settlements on behalf of our clients, including the following:
Patients who are injured by faulty heart devices may be able to file both a products liability lawsuit against the device manufacturer and a medical malpractice suit against the surgeon.
Philadelphia Medical Malpractice Lawyers at Galfand Berger LLP Offer Legal Advice to Patients Who Have Been Harmed by Heart Devices
If you have been harmed by a heart device, contact our Philadelphia medical malpractice lawyers at Galfand Berger LLP. If you have a valid claim, we will launch a thorough investigation. Contact us online or call us at 800-222-USWA (8792) to schedule a free consultation and to find out how we can help you. We serve clients throughout Pennsylvania and New Jersey, including Allentown and Harrisburg, from our offices in Philadelphia, Bethlehem, Lancaster, and Reading, Pennsylvania.