Alerta De Seguridad para OPTIMIZER® III Implantable Pulse Generator

Safety alert

2011-11-25

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20111125.html

Field safety notice: impulse dynamics optimizer® iii implantable pulse generator medical device manufacturer, impulse dynamics, has issued a field safety notice concerning optimizer® iii implantable pulse generator (ipg). impulse dynamics recently received four reports from germany concerning the optimizer iii ipg. one of the device components, the reed switch, became stuck during ipg recharge. when it became stuck the devices went into "magnet mode" which is a setting which automatically turns off cardiac contractility modulation therapy. this state can typically be changed to reinitiate therapy by reprogramming the optimizer® iii device with the omni programmer. however, a stuck reed switch affects the telemetry reception by the ipg, preventing reprogramming until the reed switch is released. the event does not present a significant risk to continued use of the device. according to innotronik hong kong limited, the affected device has been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.