Miami Defective Defibrillator Lawyer

Ways a defibrillator can fail

An ICD relies on its battery, its leads, and its detection software working together to recognize a dangerous rhythm and respond within seconds, and a failure in any one part can undermine the whole system.

• Failure to detect a life threatening arrhythmia
• Delivery of a low energy or absent shock when one was needed
• Inappropriate shocks delivered when no therapy was required
• Lead fracture, insulation damage, or dislodgement
• Battery depletion or an electrical malfunction
• Cardiac perforation caused by a lead or other component
• Infection involving the device pocket or lead system

Defibrillator recalls worth reviewing

Several defibrillator manufacturers have faced significant FDA recall action in recent years, and some of these recalls are tied directly to a device's core ability to deliver a shock.

• Medtronic's ICDs and CRT-Ds using a glassed feedthrough, a Class I recall after a short circuit protection feature could inappropriately activate and cause a low or absent shock during high voltage therapy
• Medtronic's Mirro and Primo ICD models, a Class I recall covering several specific model numbers
• Medtronic's Aurora EV-ICD extravascular defibrillator system, a Class II recall
• Boston Scientific's EMBLEM S-ICD and its Model 3501 subcutaneous electrode, subject to both Class I and Class II recall actions over several years
• Abbott's Gallant VR, DR, and HF ICD models, recalled under multiple FDA actions beginning in 2022

Symptoms and events that may point to a defibrillator problem

Some of these events happen suddenly during a cardiac episode, while others surface later during a routine device check.

• A shock that felt unnecessary or came without warning
• Fainting or a dangerous rhythm the device failed to correct
• A device alert or unusual reading during remote monitoring
• Pain, swelling, or drainage near the implant site
• Sudden device replacement recommended by your cardiologist
• Loss of consciousness during an episode the device should have treated

Compensation available in a defibrillator case

A defibrillator failure can lead to a cardiac emergency on top of the cost of correcting the device itself, and compensation may reflect both.

• Costs of emergency cardiac care and hospitalization
• Device replacement, lead revision, or extraction surgery
• Future cardiac monitoring and treatment
• Lost wages and reduced earning capacity
• Pain, suffering, and emotional distress

Because a defibrillator failure can be fatal, a wrongful death claim covering funeral expenses and prior medical costs may also be available to surviving family members.