According to two studies published in JAMA, Implantable Cardioverter-Defibrillators (ICDs) have a significantly higher malfunction rate than pacemakers.
(JAMA = Journal of the American Medical Association)
The JAMA report stated that although Pacemakers and ICDs are used by millions of patients around the world, very little had been known about their reliability. Manufacturers of pacemakers and ICDs have to submit annual reports on how many implants there are and how many have gone wrong.
The Dr. William Maisel, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, and team looked at the manufacturers’ annual reports from 1990-2002. They were looking specifically at the reported number, rate, and reasons for malfunctions of Pacemakers and ICDs.
From 1990-2002 in the USA:
— 2,250,000 pacemakers were implanted
— 415,780 ICDs were implanted
— 8,834 Pacemakers were explanted due to confirmed malfunction
— 8,489 ICDs were explanted due to confirmed malfunction
Malfunction rate was:
— Pacemaker – 4.6 per 1,000 implants
— ICD – 20.7 per 1,000 implants
Deaths due to device malfunction was:
— Pacemaker – 30
— ICD – 31
Pacemaker malfunction rate improved continuously during the twelve-year period. Half the ICD malfunctions happened during the last three years.
Half of the total device failures were due to battery/capacitor abnormalities and electrical issues.
The researchers said that ICDs break down more because they are much more sophisticated devices.
The researchers stressed that ICDs play an important role in saving the lives of many people and remain an important therapy for patients at high risk of sudden cardiac death.
The FDA funded the study.
Written by: Christian Nordqvist
Editor: Medical News Today