Medtronic Defibrillator FAQ

Q: What is a defibrillator?

A: a defibrillator is a medical device that is surgically implanted in the patient who has a type of heart ailment that results to a life-threatening heart arrhythmia which is characterize by abnormal rhythm of the heart. Defibrillators bring an electrical shock to the heart and restore the normal heart rhythm.

Q: Is there any recent news or update about the Medtronic defibrillator?

A: Medtronic Inc, the manufacturers of defibrillator, gave a warning to patients and healthcare professionals on October 15,2007 about an electrical wire which is called as “lead” that connects the defibrillator to the heart could break. Medtronic issued an announcement that they are voluntarily deferring all distribution of the “Sprint Fidelis” leads. Medtronic defibrillators included the Fidelis lead since 2004.

Then, in February 2005, US Food and Drug Administration issued a statement that Medtronic Inc delivered a notification about a particular defibrillator models. Medtronic voluntarily informed doctors about a potential battery shorting mechanic that might happen in a subset of implantable cardioverter-defibrillator or ICD and the cardiac resynchronization therapy defibrillator or the CRT-D models.

Q: Which of the devices were affected by the February 2005 notification?

A: The devices that are potentially affected by the February 2005 notification are as follows:

  • Marquis ™ VR/DR ICD
  • InSync I/II/III Marquis ™ CRT-D
  • InSync III Protect™ CRT-D
  • Maximo™ VR/DR ICD

The batteries of the devices that were produced between the periods of April 2001 and December 2003 might have this shorting action. There were approximately 75% of the above-mentioned devices were already implanted in the United States. The patients with other models or with these models with the batteries produced after December 2003 were not affected.

Q: Is there any reported deaths as a consequence of a defibrillator malfunction?

A: Until the February 2005 notification, there were no reported injuries or deaths of the patients.

Q: What should I do if I have a Medtronic defibrillator implanted?

A: Medtronic strongly recommends that the patients who were implanted with the affected devices must continue to

  • Continue with their regular and routine follow-up procedure
  • Turn on the low battery voltage Patient Alert indicator
  • Seek medical attention immediately if they experience warmth in the place surrounding the ICD
  • Use a hand-held magnet to check on the status of the device regularly. A device tone will show if it s functioning properly. The doctors are encouraged to return all the removed or explanted devices

A device tone will show if it s functioning properly. The doctors are encouraged to return all the removed or explanted devices to the manufacturer, regardless of the reasons for their removal to review and analyze these devices and know if there was a malfunction.

Q: What should I do if I think I have been injured by a faulty defibrillator?

A: If you or any of your family members were implanted with Medtronic defibrillator and are experiencing any rare medical conditions, you should contact your doctor right away. Then, you may want to find an experienced lawyer to explain and discuss your options or safeguard your legal rights to the appropriate remedy for any injury as a result of Medtronic defibrillator.

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