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What are Medtronic Defibrillators?
Copyright (c) 2008 Katie Kelley
A process in correcting a condition known as abnormal heart rhythm (arrhythmia) is when an implantable cardiovert defibrillator (ICD) is surgically implanted into the chest. The ICD monitors and corrects episodes of arrhythmia among patients.
ICDs can generate (1) a series of precisely timed low-intensity electrical pulses to reset the heart to normal rhythm when the heartbeat becomes faster than normal (ventricular tachycardia), and (2) electric shocks that may feel like a sudden kick in the chest to stop potentially fatal quivering of the heart (ventricular fibrillation).
In addition, the ICD may be programmed to work as a pacemaker and send small electrical signals to pace the heart whenever it detects an abnormally low heartbeat (bradycardia).
These electronic medical devices are placed in the body to prevent cardiac arrest from severe ventricular tachycardia. The defibrillator works by connecting a small electrode between the heart and a computer in the device. This device monitors the heartbeat and if it detects an arrhythmia, it activates a built-in pacemaker to stabilize the heart rate. If this fails, the defibrillator sends a jolt to the heart. ICDs are among the fastest-growing group of medical devices; in the year 2005 alone, more than 200,000 patients are expected to have one implanted.
An ICD can cost up to $25,000 for the device itself and uncomplicated hospital and doctor costs can run another $15,000 to $25,000. Unfortunately, the results can be fatal if a device is damaged or defected. It is believed that the Medtronic defibrillators allegedly knew of the defects prior to being sold and implanted into thousands of patients. Medtronic has recalled approximately 65,000 defective devices. Defects in Medtronic devices include internal short circuits, memory errors, and problems with magnetic switching. Ventricular tachycardia or fibrillation occurs when rapid, and fatal, threatening arrhythmias occur in the heart's lower chambers; ICDs shock the heart into normal rhythm when this occurs. Some of the defibrillators failed to charge properly, resulting in late or non-delivery of cardiac shock therapy.
FDA Recalls Defective Medtronic ICDs
In April 2004, Medtronic announced a recall of two implantable cardioverter-defibrillators which had been linked to four deaths and a serious injury. A high majority of the Micro Jewel II Model 7223Cx and the GEM DR Model 7271 ICDs, which were affected by the recall, were implanted from 1997 to 1998. It is believed that 1,800 units may have been in use during that time period.
On February 11, 2005, the Food and Drug Administration (FDA) announced that Medtronic was recalling certain ICDs due to a battery shorting defect which results in rapid battery depletion leading to loss of device function. Devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action. Medtronic then announced in February 2005 that their ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) may have battery shorts.
Defibrillators which are affected include: Marquis VR/DR Iand Maximo VR/DR ICDs and the InSync I/II/III Marquis and InSync III Protect CRT-D lines, manufactured between April 2001 and December 2003. CRT-Ds are implantable devices used to treat heart failure and other life-threatening heart rhythm disturbances by delivering electrical impulses to the heart.
On June 21, 2005, the FDA criticized Medtronic's procedures for following up on complaints about an external defibrillator, including a failure to properly investigate a patient's death. This letter focused on damaged cable connectors in the devices, which are designed to deliver a powerful shock to patients experiencing sudden cardiac arrest. However, cables that are damaged or have defects will send the wrong amount of power. The problems highlighted in the letter "may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems."
FDA Warning
The FDA has advised patients to take the following steps:
* Contact your doctor to determine if you have an affected ICD.
* Contact your doctor if you feel an electrical shock from your device.
* Contact your doctor or go to the nearest emergency room if you hear an audible "beeping" from your ICD. Medtronic and Litigation
On December 7, 2005, all federal court cases were consolidated and transferred to the Hon. James M. Rosenbaum in the District of Minnesota for further pre-trial proceedings.
About the Author
For other pharmaceutical issues, such as the Avandia heart risks or the Chantix side effects, visit the LegalView homepage at http://www.LegalView.com/ . If you wish to learn more on the Medtronic risks visit http://medtronic.legalview.com/ .
Terenine to Sponsor “Technology in Healthcare Month,” an Annual Chattanooga Technology Council Celebration
Terenine Technology Solutions, an expert in managed services, applications development and data center design and operation, is pleased to announce it is a sponsor for the Chattanooga Technology Council’s “Technology in Healthcare Month.” The annual celebration will feature three events in July that will bring together Chattanooga area information technology leaders involved in the healthcare ...
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iCD 2011 Outreach update - week 3
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ICD 10 Proves to be a Major Step Forward in Healthcare Software
ICD 10 or the International Statistical Classification of Diseases and Related Health Problems is a way to code diseases, signs, symptoms, findings, causes of injury and diseases, as classified by the World Health Organization (WHO).
The greatly expanded ICD 10 will replace the ICD 9, which contains only 17000 codes and is considered outdated because of its limited ability to accommodate new procedures and diagnoses. However, the reason why ICD 10 is in news is the new Affordable Care Act that will make it pertinent for technology companies to integrate the ICD 10 coding into the Exchange portal.
The United States will begin official use of ICD-10 on October 1, 2013, using Clinical Modification ICD-10-CM for diagnosis coding and Procedure Coding System ICD-10-PCS for inpatient hospital procedure coding. All HIPAA "covered entities" must make the change; a pre-requisite to ICD-10 is the adoption of EDI Version 5010 by January 1, 2012. The implementation of ICD-10 has already been delayed. In January 2009, the date was pushed back by two years, to Oct. 1, 2013 rather than a prior proposal of Oct. 1, 2011.
ICD 10 will impact every system, process and transaction that contains or uses a diagnosis code. The changes will have a bearing on a lot of processes including Actuarial Underwriting, Benefits Design, Budgeting and Planning Cycle, Case/Disease Management, Claims, Communications, Customer Service, Enrollment, Finance, Internal Audit/Fraud, IT Systems/Department, Legal/Government Relations/Compliance, LOBs, Provider Contracting, Provider Relations, Reporting, Testing, Training and Vendor Oversight.
ICD10 will help healthcare organizations to keep pace with the several changes that the reforms are bringing in. there are significant alterations in administrative transactions, some of which include requirements for national payer ID, electronics claims attachment and updates to HIPPA transaction every two years.
Centre for Medicare and Medicaid Services will soon conduct a survey to find out about the healthcare industry awareness about ICD 10 and preparedness for transition Version 5010 and ICD 10. The survey will be conducted as soon as CMS receives the approval from the Office of Management and Budget.
On January 16, 2009, the HHS (the Department of Health and Human Services) declared the final regulations in adopting Version 5010 and ICD 10; the two standards of HIPAA transactions. Entities have to first implement Version 5010 before they can implement ICD 10. By January 2011, entities also have to begin meeting interim milestones such as gap analysis, design, development and internal testing.
The aggregated data obtained through the survey will help CMS to improve it outreach program and help educate the healthcare providers, payors, clearinghouses and vendors so that they are able to meet these interim challenges. The education campaign designed by CMS is to support the transition to and adoption of Version 5010 and ICD 10 and will target healthcare professionals who have to take steps to implement the new codes and transaction standards.
About the Author
Shaun Mike is well known authority on health insurance in the US. He is currently looking to expand his expertise to health insurance and other healthcare software available.
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