Important Safety Alerts

Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Accolade family pacemakers, the devices are identified as follow:

• Product: A) Single Chamber Pacemakers; B) Dual Chamber Pacemakers; C) Cardiac Resynchronization Therapy Pacemakers (CRT-Ps)
• Model: A) L200 PROPONENT Pacemakers, S701 ALTRUA 2 Pacemakers; B) L121 ESSENTIO Pacemakers, S702 ALTRUA 2 Pacemakers, S722 ALTRUA 2 Pacemakers; C) U128 VALITUDE CRT-P

During a review of warehouse inventory, a discrepancy was identified between the box/tray label and the nominal device values shown on the programmer screen(s) for an Accolade family pacemaker. Further investigation identified the following errors on box and tray labels for certain Accolade family pacemakers and CRT-Ps:

• For Single Chamber, Dual Chamber and CRT-P Models, the box and tray labels for nominal Ventricular Amplitude reads (3.5mV). The correct value is (3.5V);
• For Single Chamber Models, the box and tray labels include a value for Paced AV Delay and Sensed AV Delay. They should not be included on the labels, as they do not apply for single chamber devices;
• For Single Chanber Models, the box and tray labels for the Ventricular Refractory RV (Max/Min) read 250ms/230ms. The correct value is 250ms/250ms.

The manufacturer has determined that this is a box and tray labeling discrepancy and has no impact on device or programmer performance. The nominal parameters printed on the table are not options available for programming by the user when the device is programmed in VVI mode (at nominal settings). There is no foreseeable risk to patient safety. The affected inventory may be safely implanted and used with the accompanying documentation.

According to the local supplier, the affected box and tray labels are only on product distributed in China. Accolade pacemakers and CRT-Ps distributed to other countries do not include the affected nominal settings table on the box/tray. There is no affected customer in Hong Kong.

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

Posted on 24 August 2018