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St. Jude Medical issues advisory on early battery depletion of ICDs, CRT-D devices
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St. Jude Medical issued a medical device advisory regarding premature battery depletion associated with lithium deposits in some of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillator devices.
According to a press release issued by the company, the problem has occurred in 0.21% of ICDs and CRT-D devices manufactured before May 23, 2015.
The company stated that after consultation with its medical advisory board, it has issued the following recommendations:
- Doctors should inform their patients about the advisory, but do not need to replace the device unless they determine it is necessary.
- Patients can check if their device is affected by visiting www.sjm.com/batteryadvisory.
- The devices activate a vibratory alert if the battery nears depletion. Patients should contact their doctor if they experience this.
- If patients are not yet enrolled in the Merlin.net remote monitoring service, they should do so; the service will be provided at no cost to patients with affected devices.
- If a decision is made to replace an affected device, St. Jude Medical will provide a free replacement.
Because the company’s pacemakers are powered by low-voltage batteries, they are not affected, according to the release.
“Our highest priority is the safety of patients depending on our life-sustaining technology and we are working with regulators and physicians to communicate about this advisory and the resources we are providing to assist with patient management,” the company stated in the release.