Article at a Glance
- Medtronic has recalled some of its cardiac defibrillators and implantable devices, with 48 models identified as “high risk.” Their defect might result in “arcing” during charging, which would result in the devices later failing when used during cardiac arrest.
- One field failure has been reported with Medtronic devices since the recall. If you have a Medtronic device and it’s part of the recall, or another Medtronic device has failed and caused injuries to you or a loved one, contact our experienced medical device attorneys today.
Earlier this year, Medtronic issued a two-stage voluntary recall of various cardiac defibrillators, including some implantable devices. The initial recall involved 48 devices the company had identified as “high risk,” and the second an additional 752 devices classed as lower risk, but still subject to possible failure.
This post will review what a Medtronic defibrillator is, information about the recall, and what injured patients in Ohio can do.
What is a Medtronic defibrillator?
A defibrillator is used to shock the heart back into rhythm when it stops or when a life-threatening disruption in rhythm occurs. Most people are familiar with the large, hospital-based defibrillator paddles that are often seen on television, and have become an increasingly popular addition to first-aid supplies at schools and sporting events.
The Medtronic devices in question are smaller, implantable devices designed to react automatically and deliver a shock when necessary to jolt the heart back into rhythm. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) is a combination device that helps the lower chambers of the heart work in tandem, but also includes defibrillation capability. The Implantable Cardioverter Defibrillator (ICD) is a defibrillation-only device.
What’s wrong with Medtronic defibrillators?
In January 2018, Medtronic issued a recall on certain ICDs and CRT-Ds manufactured between July 13, 2013 and August 8, 2017. Medtronic said that due to a defect in the manufacturing process, the devices might fail to deliver the electric shock necessary to pace a patient’s heartbeat or revive a patient in cardiac arrest.
The defect resulted in possible “arcing” during high voltage charging. Arcing involves a high-power discharge that translates to heat, and can burn through or damage conductive wires. With this initial group of defibrillators, which Medtronic identified as high-risk, the company projected that 7.7% of the devices would fail within the first two high-voltage charges, and up to 23% would fail if the device delivered the maximum number of shocks available in the lifetime of the battery.
Device failure may result in serious injury or death.
In March 2018, Medtronic extended the recall to 752 devices that it classified as lower risk. For these devices, Medtronic projected failure rates of 0.18% within the first two high-voltage charges and 0.5% if the devices delivered the maximum number of charges possible within the battery life.
Harm Associated with Faulty Medtronic Defibrillators
As of March 2018, Medtronic reported only one field failure and no deaths associated with the higher-risk group of devices. No field failures had been reported with regard to the lower-risk category.
However, the fact that only one person has suffered a failure and there have been no fatalities to date does not mean that no damages have been sustained. Replacement of implanted devices requires an additional surgical procedure, subjecting the patient to additional risks of surgical complications, recovery time, and pain and suffering. If there are complications in the replacement procedure, damages may be much more significant.
In addition, the patient will accrue another round of medical bills, and be subjected to the stress of knowing that the device is unreliable in the period between notification and the replacement procedure. Medtronic warns that successful delivery of high-voltage shocks by the device should not be interpreted as a guarantee of ongoing functionality. In other words, the fact that one of the recalled devices has worked fine so far is no indication that the device will continue to operate safely and effectively.
Next Steps for Patients with Medtronic Defibrillators
If you have a Medtronic defibrillator and have experienced any problems whatsoever, contact your physician immediately. If you have not experienced any problems with the device, check the list of recalled devices and contact your cardiologist or cardiac surgeon right away if your device is on the list. If you’re not sure which device you have or whether you are at risk, consulting your doctor is the best first step.
If you have suffered ill effects from a defective defibrillator or have been required to undergo additional medical procedures and compound your medical expenses, you may be entitled to damages.
However, pursuing a defective medical device claim can be very difficult. Constructing a case requires not only a thorough knowledge of substantive and procedural law, but also an understanding of the medical and scientific issues in play, and access to expert witnesses.
The defective medical device litigation attorneys of Plevin & Gallucci have the knowledge, experience, and network required to build a strong case on behalf of victims of faulty medical devices. Our attorneys have decades of experience in representing injury victims, those who have suffered medical malpractice, and those affected by defective products such as medical devices. If you have been impacted by the Medtronic defibrillator recall, schedule your free consultation right now.