British researchers issued a medical alert Friday for Medtronic's EnTrust defibrillators and warned that the implantable device might fail to properly shock a patient's heart due to an abnormally-shortened battery life.
Saying it was "urgent," researchers from the Medicines and Healhcare Products Regulatory Agency (MHRA) warned patients with various EnTrust models to see their doctors within a month if the device had been implanted over 28 months ago.
Those with younger models of the device were encouraged to see their doctors in three months so physicians could make sure an audible "low-battery" alert was programmed "on."
All applicable patients will be enrolled in a CareLink followup program with Medtronic, but none are expected to have the device removed, agency officials said.
Fridley-based Medtronic has sold roughly 69,000 EnTrust defibrillators worldwide in the last seven years. Medtronic said in a statement fewer than 1 percent of patients with the device had problems with a depleted battery. "No patient deaths or serious injuries have been reported as a result of this issue," Medtronic's statement added.
In 2008, Medtronic did not admit wrongdoing, but settled lawsuits claiming that it hid battery defects in its Marquis line of defibrillators for $114 million.
Dee DePass • 612-673-7725