Parker Waichman LLP

Caution With New Leadless Defibrillator Devices

Cardiologist is again urging caution on the use of a new implanted cardiac defibrillator device. A leading and outspoken cardiologist is again urging caution on the use of a new implanted cardiac defibrillator device. According to a Reuters report this week, Dr. Robert Hauser writes in the most recent edition of Journal of the American College […]

leadless defibrillator devices

Cardiologist is again urging caution on the use of a new implanted cardiac defibrillator device. A leading and outspoken cardiologist is again urging caution on the use of a new implanted cardiac defibrillator device.

According to a Reuters report this week, Dr. Robert Hauser writes in the most recent edition of Journal of the American College of Cardiology that Boston Scientific’s new cardiac defibrillator device that does not use lead wire technologies to deliver shocks to a recipient’s heart, a device known as a subcutaneous implantable cardioverter-defibrillator (S-ICD).

Boston Scientific acquired the rights to these devices when it purchased Cameron Health in 2012. The Food and Drug Administration only recently approved the device in the final quarter of 2012 and did so among swirling controversies over the class of implanted cardiac defibrillator devices.

Implanted defibrillators typically rely on small wires connecting from the device to a recipient’s heart

Implanted defibrillators typically rely on small wires connecting from the device to a recipient’s heart. The defibrillators are designed to either deliver shocks to keep a heart beating or timed pulses to regulate a heart rhythm.

Problems with these lead wires has resulted in hundreds of serious injuries and deaths to recipients of the devices. In at least one instance, with another company’s specific type of lead wire, the lead was prone to breaking free of its protective housing on the conductive end of the lead wires.

These defects led to defibrillators not delivering shocks when they were supposed to or delivering unnecessary shocks as well as internal injuries like lacerations to the heart and other sensitive organs near the defibrillator.

issued public statements through medical journals regarding his skepticism of other implantable cardiac defibrillator devices

Hauser, who is employed as a cardiologist at Minneapolis Heart Institute and works independently as a medical devices researcher, has previously issued public statements through medical journals regarding his skepticism of other implantable cardiac defibrillator devices, including the recalled St. Jude Riata, Riata ST, and other devices. Reuters reports that Hauser has again signaled an alarm regarding these new leadless defibrillators.

For people who believe they may be at risk of suffering from the failures of their defective cardiac defibrillator or for those who must now weigh their options with a new device, many may believe that a new and “wireless” device may be best. He writes in his journal entry: “The S-ICD has not yet been shown to be effective in a diverse patient population.

Unless critical questions with regard to safety and efficacy in primary and secondary prevention are addressed, the S-ICD should be confined to certain subgroups.”

Need Legal Help Regarding leadless defibrillator devices?

The personal injury attorneys at Parker Waichman offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
My personal experience with my legal team at Parker Waichman LLP was exceptional in every right and highly recommendable by me for anyone needing expert legal counsel.
Steven Clark
a year ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value PW already a reputable Law Firm still exceeded my expectations. PW did an outstanding job.
Charles Jones
3 years ago
5 Star Reviews 150
I have been working with Parker and Wachman for 7 months. The experience has been not only professional but comfortable. Joanne Stevens, the nurse assigned to my case, has been diligent in assisting me with medical issues. She has been responsive to my issues. I am appreciative of this experience.
Treasures from Jones Health and Wellness
5 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard, Suite 108
Bonita Springs, FL 34134
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050