What is the likely cause of a pacemaker malfunction in a 63-year-old male with hypertension, hyperlipidemia, and a history of atrial fibrillation, who underwent ablation and received an Assurity (Medtronic) pacemaker, which was manufactured with incorrectly mixed glue and epoxy, resulting in fluid leakage and a decreased heart rate to 30 beats per minute, indicating bradycardia?

From the Guidelines

As a plaintiff attorney deposing the plaintiff's expert in a case involving a defective pacemaker, it is crucial to thoroughly investigate the manufacturing defect, its impact on the patient's health, and the potential negligence of the manufacturer. Here are 30 questions for the deposition:

• Can you explain your qualifications and experience with cardiac pacemakers, particularly with the Assurity model 1?
• What is the normal function of an Assurity pacemaker, and how does it differ from other pacemaker models?
• How does the manufacturing defect in the glue and epoxy mixture affect pacemaker function, and what specific damage occurs when fluid leaks into a pacemaker?
• Is a heart rate of 30 beats per minute dangerous for this patient, considering his pre-existing conditions such as hypertension, hyperlipidemia, and history of atrial fibrillation?
• What symptoms would a patient experience when a pacemaker drops to 30 beats per minute, and how would these symptoms impact his quality of life?
• What immediate medical risks did this malfunction pose to the patient, and what long-term health consequences might result from this malfunction?
• Could this malfunction have been fatal under certain circumstances, and what factors would contribute to such an outcome?
• What quality control measures should have prevented this manufacturing defect, and what industry standards exist for pacemaker manufacturing and testing?
• Were Abbott's manufacturing processes in compliance with FDA regulations, and what evidence supports or refutes this claim?
• How frequently do manufacturing defects occur in cardiac pacemakers, and what testing should have detected this defect before implantation?
• How long was the defective pacemaker functioning in the patient, and what medical interventions were required after the malfunction was discovered?
• Did the patient require surgery to replace the pacemaker, and what complications are associated with pacemaker replacement surgery?
• What physical limitations did the patient experience due to the malfunction, and what emotional distress typically results from pacemaker failure?
• How did the patient's pre-existing conditions affect the severity of the malfunction, and what is the standard of care for pacemaker manufacturing quality assurance?
• Could this defect have been detected during routine pacemaker checks, and what monitoring should Abbott have implemented at their manufacturing facility?
• How widespread was this manufacturing defect across other devices, and what remedial measures has Abbott taken since discovering this defect?
• What is the life expectancy of a properly functioning Assurity pacemaker, and how has this incident affected the patient's prognosis and future medical needs?
• What ongoing medical monitoring will be required for this patient, and what is the total economic cost of this malfunction, including medical expenses and lost wages?
• Can you describe the potential risks of electromagnetic interference with pacemakers, as outlined in the ESC guidelines 1?
• How do hospital environments pose risks of electromagnetic interference with pacemakers, and what precautions should be taken during procedures such as electrocautery and lithotripsy?
• What considerations apply to catheter ablation and MRI procedures for pacemaker-dependent patients, and how do these procedures impact pacemaker function?
• What is the role of the plaintiff's expert in evaluating the manufacturing defect and its impact on the patient's health, and how will you determine the extent of the damages?
• Can you provide examples of similar cases involving defective pacemakers, and how were they resolved?
• What are the implications of this case for the medical device industry, and how might it impact future manufacturing and testing protocols?
• How will you assess the patient's current and future medical needs, and what recommendations will you make for his ongoing care?
• What is the potential for future complications or adverse events related to the defective pacemaker, and how will these be mitigated?
• Can you discuss the potential for a class-action lawsuit, given the potential scope of the manufacturing defect?
• How will you work with the plaintiff's attorney to build a strong case, and what evidence will you present to support the plaintiff's claims?
• What are the key takeaways from this case, and how will they inform your future work as an expert witness in similar cases?

From the Research

Deposition Questions for Plaintiff Expert

The following questions are designed to gather information about the plaintiff's condition, treatment, and the pacemaker's malfunction:

• What is the plaintiff's medical history, including the diagnosis of hypertension, hyperlipidemia, and atrial fibrillation?
• Can you describe the plaintiff's symptoms and treatment prior to the pacemaker implantation?
• What type of pacemaker was implanted, and what were the expected benefits and risks of the device?
• How did the plaintiff's condition change after the pacemaker implantation, and what symptoms did they experience?
• Can you explain the significance of the pacemaker's malfunction, including the drop in heart rate to 30 beats per minute?
• What are the potential consequences of the pacemaker's malfunction, including any long-term effects on the plaintiff's health?
• How does the plaintiff's condition relate to the studies on atrial fibrillation and pacemaker therapy 2, 3, 4, 5?
• Can you discuss the importance of anticoagulation therapy in patients with atrial fibrillation, as described in the study by 3?
• How does the plaintiff's case illustrate the need for combined antithrombotic therapy in patients with atrial fibrillation and coronary artery disease, as discussed in the study by 4?
• Can you explain the expected pacing need for patients with dual-chamber pacemakers, as described in the study by 5?
• How does the plaintiff's experience with the pacemaker's malfunction relate to the ethical principles guiding patient prioritization during disaster triage, as discussed in the study by 6?

Pacemaker Malfunction and Medical History

The following questions are designed to gather more information about the pacemaker's malfunction and the plaintiff's medical history:

• Can you describe the factory's error in mixing the glue and epoxy for the pacemaker, and how this error led to the device's malfunction?
• What were the immediate consequences of the pacemaker's malfunction, and how was the plaintiff treated?
• How has the plaintiff's condition changed since the pacemaker's malfunction, and what ongoing treatment have they received?
• Can you discuss the potential long-term effects of the pacemaker's malfunction on the plaintiff's health, including any increased risk of stroke or other cardiovascular events?
• How does the plaintiff's medical history, including their diagnosis of hypertension and hyperlipidemia, relate to their experience with the pacemaker's malfunction?

Expert Opinion and Conclusion

The following questions are designed to gather the expert's opinion on the plaintiff's case and the pacemaker's malfunction:

• Can you provide an expert opinion on the cause of the pacemaker's malfunction and its relation to the factory's error?
• How does the plaintiff's experience with the pacemaker's malfunction illustrate the importance of proper device manufacture and testing?
• Can you discuss the potential implications of the pacemaker's malfunction for public health, including any increased risk of adverse events in patients with similar devices?
• How does the plaintiff's case relate to the broader context of medical device regulation and patient safety, as discussed in the studies by 2, 3, 4, 5, 6?