The agency warns that defective devices might deliver an insufficient shock, or fail to provide any shock at all, to patients in need
Medtronic is recalling approximately 350,000 implantable cardiac defibrillators from the market due to persistent issues concerning the deployment of high-voltage energy, says a statement from the US Food and Drug Administration. The FDA has classified the recall as Class I, its most severe category.
“A low-energy shock, or even the absence of shock, might not rectify a fatal arrhythmia, potentially leading to cardiac arrest, other serious harm, or death,” the FDA stated in its recall notice. The notice also stated, “Patients possessing these devices might face further risk of injury should they require extra surgical operations for the removal and replacement of the device.”
The recall concerns certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) that were circulated between October 2017 and June 2023. The faulty devices, equipped with a glass feedthrough component, might deliver insufficient or no energy when necessary due to the improper triggering of the short circuit protection feature, the agency elaborates.
There have been 28 reported incidents and 22 injuries thus far, but fortunately, no fatalities. Medtronic had previously pulled back more than 87,000 devices the previous year owing to a similar energy delivery issue.
The devices encompassed in the current recall include the Cobalt and Cobalt XT, Crome ICDs and CRT-Ds; Claria MRI, Amplia MRI, Compia MRI, Viva, and Brava CRT-Ds; and the Visia AF and Visia AF MRI, Evera, Evera MRI, Primo MRI, and Mirro MRI ICDs.
The company advising physicians against replacing already implanted devices, as per the notice. They have issued directives for device programming to lower the risk associated with the problem and advise remote patient monitoring following regular protocols. Both healthcare professionals and consumers are urged to report any adverse effects or issues with the devices to the FDA’s MedWatch Safety Information and Adverse Event Reporting System.
Understanding the Need to Pursue Legal Action for Compensation and Redress in Defibrillator-Related Damages
For those adversely affected by a faulty Medtronic defibrillator, the decision to file a lawsuit can play a crucial role in securing justice, compensation, and redress. Here’s why pursuing legal action can be essential:
- Compensation for Medical Expenses: Health complications arising from defective medical devices often necessitate costly medical treatments. A lawsuit can aid in recouping these costs.
- Compensation for Pain and Suffering: Experiencing physical distress and emotional trauma is common for victims of malfunctioning medical devices. Legal proceedings can provide compensation for these injuries.
- Compensation for Wrongful Death: If a defective device contributes to the death of a patient, their family may be entitled to compensation for loss of companionship, income, funeral expenses, and other damages related to their loved one’s death.
- Release Damages: Victims might be eligible for release damages, which provide compensation for future harms that could arise from the medical issue caused by the defective device.
- Punitive Damages: Should the company’s actions be deemed exceedingly harmful or negligent, the court may award punitive damages to discourage similar misconduct in the future.
- Raising Awareness: Launching a lawsuit can spotlight a grave issue, potentially preventing similar harm to others in the future.
- Holding Corporations Accountable: Victims can hold the culpable company to account through a lawsuit, thereby pressing them to enhance their safety protocols.
If you’re contemplating a lawsuit, it’s vital to engage a knowledgeable product liability or personal injury lawyer who can guide you through your rights and the legal procedure.
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