Defibrillator Defined

A defibrillator is a medical device that is surgically implanted in patients who have a type of heart ailment that brings a life-threatening heart arrhythmia, a medical condition where there is abnormal rhythm of the heart. Defibrillator gives an electrical shock to the heart to restore normal rhythm of the heart.

Faulty Defibrillator Component 2007 Warning

Medtronic Inc issued a warning on October 15, 2007, informing the patients and healthcare professionals that there was an electrical wire, called as “lead” that connects the defibrillator to the heart that could break. Medtronic stated that it has voluntarily deferred all the distribution of the “Sprint Fidelis” leads. Medtronic defibrillators included Fidelis lead since 2004. Medtronic gave a press release that stated an approximated 268,000 patients who have been implanted with Sprint Fidelis leads might experience lead fractures such as “audible alerts, inappropriate shocks and/or loss of output.” The manufacturer identified five deaths where it was believed that a Sprint Fidelis lead fracture might have been possible factor. Medtronic does not recommend replacement of the leads because of the risks posed by the implant of a different lead might be greater compared to the risks introduced by the fracture of the Sprint Fidelis lead.

2005 Notification about Medtronic Defibrillator

The US Food and Drug Administration stated that Medtronic Inc issued a notification in February 2005 about some implantable defibrillator models. Medtronic voluntarily advised the doctors regarding a potential battery shorting mechanism that may happen in a subset of implantable cardioverter-defibrillator or ICD and cardiac resynchronization therapy defibrillator or the CRT-D models.

Medtronic declared that there were nine batteries have experienced fast battery depletion because of shorting action. If shorting happens, the battery depletion can occur within several hours to several days, after which there will be malfunction of the device.

Up to the time of the notification from Medtronic, there has been no reported injuries or deaths of patients.

The following are the devices that are affected by the notification in 2005:

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

The devices with batteries produced between the period of April 2001 and December 2003 might show this shorting action. Estimatedly, there were 75% of the above-mentioned devices were implanted in USA. The patients with other models or these models with batteries produced after December 2003 are not affected.

Recommendations

Medtronic strongly recommends that patients with implanted with the affected devices should:

• Continue with their regular, routine follow-up procedure
• Turn on the low battery voltage PatientAlert indicator
• Seek for medical attention immediately if they experience warmth in the area around the ICD
• Use the hand-held magnet to check the device status regularly; a device tone will show if it is functioning well.

The doctors are encouraged to return all removed or explanted devices to the manufacturer, no matter what the reasons are for the removal, to analyze these devices and know if there had been any malfunctioning of the device.

Obtaining Legal Assistance

It is the responsibility of the medical device manufacturer to manufacture products that are safe and effective and inform the medical community and the general public of the risks related with their products. If the manufacturer failed to do this, it can be held liable if the patients are injured as a consequence of insufficient warnings or the hazardous nature of the medical device, under the legal principle known as “product liability.”

If you or any of your family members have been implanted with Medtronic defibrillator and are suffering from health problems, you should seek medical attention immediately. Then, you can contact an experienced lawyer who can explain and discuss your options and safeguard your legal rights to remedy for any injury caused by Medtronic defibrillator.