Pacemakers are medical devices that serve a lifesaving purpose. They help to control abnormal heart rates, which can improve overall cardiovascular health in individuals with certain heart problems. Pacemakers can also reduce symptoms related to heart disease.
However, a pacemaker with a defect may become even deadlier than the underlying heart condition. If a pacemaker is defective, it may lead to complications and potentially life-threatening infections. You’ll need multiple operations to replace it, and that’s assuming you survive the initial problem.
About Pacemakers
There are a variety of different pacemakers on the market, manufactured by many different companies. However, most pacemakers have the same two important components. The first is the generator, which is responsible for causing electric impulses that regulate the heart rate. The second is wiring that delivers those pulses to the important areas.
There are also new pacemaker models on the market that feature a wire-free design. These objects are smaller than their predecessors and are considered an improvement because they reduce a person’s infection risk allowing for faster recovery after surgery.
Pacemaker infections occur most frequently when people have their devices replaced. It’s rarer for an infection to occur with the initial surgery, but it can happen.
The problem is that sometimes there will be manufacturing defects in the pacemakers. If there’s an error during construction, it doesn’t matter which design you have. You’re still in danger of serious complications.
Faulty Pacemaker Risks
Medicare has spent billions of dollars replacing defective heart-related medical devices. Among these are pacemakers. The Health and Human Services Department reports that injury and death can occur in faulty pacemakers for the following reasons:
- The generator or wiring was programmed improperly or failed before it was supposed to.
- The wires were dislodged and led to infections.
- The battery needed to be upgraded in a short period of time. Normal pacemakers need upgrades at around seven to 10 years.
- There were flaws in the manufacturing or design of the pacemaker, including detached parts, perforations, and faulty batteries.
Because the FDA regulates pacemaker manufacturing, it may recall pacemakers that are found to be defective.
Recalls
There have been quite a few pacemaker recalls over the past few years. Three Medtronic pacemaker models were recalled in 2015 because of battery problems.
Perhaps more ominously, Abbott had to recall hundreds of thousands of pacemakers that could connect to WiFi. Since WiFi-enabled devices can be hacked, these devices put people’s lives were at risk. Shortly after that, Abbott also had to recall hundreds of thousands of implantable defibrillators, for exactly the same reason.
If there are issues related to your pacemaker, you’re likely to be notified by your doctor. The manufacturer of the pacemaker may also contact you, provided they have your contact information. The first person you should speak to about a faulty pacemaker concern is your doctor.
People with pacemakers often don’t know about the damage until they develop an infection or learn about a recall. Then they have to go through additional removal and replacement surgeries, which increase their infection risk.
Recalls are sorted into three types:
- Class III recalls indicating that there was a legal issue surrounding the pacemaker. However, there is very little or no risk to the patient.
- Class II recalls relating that there is a risk of complications or death to patients because of a defect in the device.
- Class I recalls are rare. They are only issued when the threat to life is the most severe.
Legal Action
If you think you have a defective pacemaker, you can schedule a free consultation with a personal injury lawyer. Medical costs associated with pacemaker problems can be quite steep. Make sure to have an experienced lawyer by your side to help you get the compensation that you deserve.
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