a sample size of ONE is just that ... one. Patients should be concerned about more pressing issues .... such as take your heart medication as prescribed, exercise as directed by your physician, common sense stuff ...
But alleged Pacemaker malfunctions always lead the headlines ...
Weakened ICD Header Bond: Abnormality Not Limited to Subpectoral Implants
Joseph J. Germano, Alicia Darge, William H. Maisel
Introduction
In December 2009, Boston Scientific (Natick, MA) issued a Product Advisory reporting that mechanical stress associated with subpectoral ICD implantation may
weaken the bond between the header and the titanium case in Cognis cardiac resynchronization therapy defibrillators (CRT-Ds) and Teligen implantable cardioverter
defibrillators (ICDs). Boston Scientific specifically noted that the Product Advisory did not affect subcutaneous implants. This report contains the details of a patient with a Boston Scientific Cognis
CRT-D with a subcutaneous implant who experienced a weakened bond between the device header and case resulting in noise and inappropriate therapies.
http://www.heartrhythmjournal.com/inpress
(See attached file: Heart Rhythm_Subpectoral Implant_Boston Scientific_February 2009.pdf)
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