Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its INLIVEN Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) [Model W275].

According to the manufacturer, fifty-five (55) Model W275 INLIVENTM Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) distributed by Boston Scientific in France and the Czech Republic are affected. Label diagrams on the outer box and inner tray packaging of affected devices incorrectly describe the location of the lead ports on the device header. The correct lead port locations are etched on the case of the pacemaker and are visible at implant. The physician technical manual is also correct.

If a pacing lead were to be inserted into the incorrect header port, inappropriate pacing could lead to loss of AV or RV/LV synchrony, possibly with worsening heart failure until corrected. Inappropriate pacing can be detected through standard device testing by evaluating either the intracardiac or surface electrocardiograms (ECG).

The manufacturer advises affected users to take the following actions:-

• Ensure that pacing leads are inserted into the correct lead ports.
• Verify that all pacing leads are connected to the correct ports, either by reviewing device operation on intracardiac or ECG strips in medical records from a previous visit or by patient follow-up.

According to the local supplier, the affected batch of products is not distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 23 September 2015