Medtronic Inc.’s EnTrust defibrillator, used to shock a stopped heart back into a normal rhythm, has a battery defect that may leave patients vulnerable to dangerous electrical abnormalities, British regulators said.
Patients with the devices should be checked immediately by their cardiologists to ensure that the defibrillators are properly programmed to give an audible alert if the battery runs low, according to the Medicines and Healthcare products Regulatory Agency. The devices may stop providing electrical pacing and lose the ability to shock the heart because an internal short circuit may cause the batteries to rapidly deplete, the agency said today in a statement.
Patients should be checked every three months and enrolled in the CareLink program that can help monitor problems, the MHRA said. The agency said it doesn’t recommend removing the devices, which are prone to fail because of battery depletion more than 2.5 years after they are implanted. While Minneapolis-based Medtronic is investigating the issue, the defect appears to be limited to the EnTrust defibrillators, the agency said.
About 69,000 EnTrust devices have been sold worldwide since 2005, the agency said. Less than 1 percent of patients have experienced the rapid voltage decline that triggered the safety alert, the MHRA said. It’s unclear how many devices may be affected after they have been in the body for more than 30 months, the agency said.
There have been no patient deaths or serious injuries because of the battery issue, Medtronic said in a statement. While patients typically have three months of normal operation after a weak battery signals a need for replacement, the EnTrust devices may give out sooner, the company said.
Medtronic settled lawsuits claiming that it hid battery defects in its Marquis line of defibrillators for $114.1 million in 2008. The company didn’t admit any wrongdoing.