Important: Check your St Jude Medical cardiac devices

 

Issues with cardiac devicesThe Medicines and Healthcare products regulatory agency has issued a drug alert to medical professionals after an issue was found with implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) manufactured by St Jude Medical. The models affected are listed below.

The issue relates to rapid battery depletion in devices manufactured between January 2010 and 23 May 2015. It is estimated that 350,000 devices have been implanted worldwide, of which around 9,000 were in the UK.

Cardiologists and cardiac physiologists have been advised to identify any patients who have had the device implanted, check the battery status and ensure that patients can feel their vibratory alert. The vibratory alert is a signal that the batter needs replacing and anyone who feels one should call their cardiac centre immediately.

What should you do?

Gary Walker, a product liability specialist at Foot Anstey has successfully recovered compensation for patients who have experienced problems with their ICDs and says: “the battery depletion in these devices presents a safety risk to patients who have had them implanted. If you suspect that you or a family member may have a St Jude Medical ICD or CRT-D implanted, or if you have concerns that your device is not working correctly, then you should contact your cardiologist as soon as possible.”

More information about the devices and what you should do can be found on the St Judes Medical website.

The models affected by the battery defect are as follows:

Device Family UK model numbers UK launch
Fortify CD1233-40, CD1233-40Q, CD1235-40, CD1235-40Q, Q1 2010
Fortify CD2233-40, CD2233-40Q, CD2235-40, CD2235-40Q Q1 2010
Unify CD3235-40, CD3235-40Q, CD3251-40, CD3251-40Q Q1 2010
Assura CD3267-40, CD3267-40Q, CD3261-40, CD3261-40Q Q1 2012
Assura CD3361-40, CD3361-40C, CD3361-40Q, CD3361-40QC Q1 2012
Assura CD3367-40, CD3367-40C, CD3367-40Q, CD3367-40QC Q1 2012
Assura CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC Q1 2012
Assura CD2259-40, CD2259-40Q, CD1259-40, CD1259-40Q Q1 2012
Assura CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC Q1 2012
Assura CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC Q1 2012