Ingenio (pacemakers)

2021: Recall of defective pacemakers that experience malfunctioning

In early August 2021, Boston Scientific recalled Ingenio pacemakers, including the Advantio DR EL, Ingenio DR EL and Vitalio DR EL models, and pacemakers for resynchronization therapy due to malfunctions. Due to the defect, the devices go into safe mode designed for backup without warning, the company said. In this case, the device cannot be reprogrammed and must be replaced.

The recall includes 48,000 devices that were sold between November 2011 and August 2020. Overall, 65 incidents were reported for marriage, including three injuries that required patients to have temporary external pacing. No deaths were reported.

Boston Scientific recalls defective Ingenio pacemakers that have malfunctions

Boston Scientific has sent out special recommendations to all affected customers that suggest they only plan to replace the pacemaker if it malfunctions. Boston Scientific does not recommend preventive replacement of supposedly defective devices. However, in individual patients, in the presence of aggravating factors, such as dependence on pacing, the possibility of early replacement of the device to prevent adverse events may be considered.

In the case of EL pacemakers, replacement is proposed if the remaining service life of the device is four years or less, in the case of pacemakers for resynchronization therapy - if the remaining service life of the device is three years or less. Also, doctors recommend monitoring the system remotely or personally at least once every 12 months.

In addition, the company asks physicians to report adverse events that occur when using these devices through the Boston Scientific Adverse Event Reporting Program or FDA MedWatch.^[1]

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