Medtronic EnTrust Defibrillator Battery Problems Results in Warning
Defective batteries could be causing problems with Medtronic EnTrust defibrillators, where the device may fail to deliver life-saving shocks to the heart, U.K. health regulators warn.
In a Medical Device Alert (pdf) issued last month, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of battery failures plaguing the Medtronic EnTrust implantable cardioverter defibrillators (ICDs). According to the warning, the batteries may rapidly fail after about two and half years.
The MHRA is calling for doctors to follow-up with all patients who have a Medtronic EnTrust ICD that is older than 28 months, to make certain the batteries are in working order. Medical providers are also being urged to check all patients with the ICDs to make sure that the “Low Battery Voltage ERI” and “Excessive Charge Time EOL” alerts are turned on and to advise patients to immediately contact a healthcare professional if the alert sounds.
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The EnTrust ICDs affected by the warning include model numbers D153ATG, D153DRG, D153VRC, D154ATG, D154DRG and D154VRC. About 69,000 of the ICDs have been sold worldwide over the last seven years. Medtronic says there have been no deaths or serious injuries reported in connection to the battery failures.
The warning is the latest in a string of problems involving ICDs. The internal defibrillators are designed to be implanted near a patient’s heart, monitor his or her heart rhythms and give life-saving electrical shocks if necessary.
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