Implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

St Jude Medical issued a Field Safety Notice addressing this issue on 10th October 2016.Approximately 350,000 devices are estimated to remain implanted worldwide, manufactured between January 2010 and 23 May 2015, with just under 9,000 sold in the UK.
Devices manufactured after 23 May 2015 are not affected due to a design improvement.Lithium clusters can occur in any high voltage device battery with lithium based chemistries. Factors such as the specific battery design and charge density can determine whether cluster formation presents a risk to battery performance. These clusters can induce a short circuit that causes premature battery depletion, depending on their location. The shorts are unpredictable, can drain the battery in days to a few weeks, and tend to occur during high voltage charging. Under this fault condition the ICD will not meet its nominal 3 months safety margin between ERI (elective replacement indicator) and EOL (end of life) and instead this has been reported to be as short as 24 hours.To date only 0.2% of affected devices are reported to have experienced premature battery depletion due to this mechanism. However, the failure rate as implant duration increases beyond 6 years is as yet unknown. Worldwide there have been 10 reported incidents of syncope (fainting) and 2 deaths (1 of which was in the UK) from lack of defibrillation therapy that may have been linked to lithium cluster induced short circuits.Although most devices will reach ERI due to normal battery depletion, it is not possible for centres to quickly differentiate these from the few that are affected by this failure mechanism. There is no way to predict which devices will suffer a lithium cluster induced short circuit and so it is important to detect ERI as soon as it occurs and replace the device as quickly as possible. At present, the risk of patient harm from revision surgery is generally greater than that of device failure, so prophylactic explant is not recommended. The relative risks, however, should be assessed on an individual patient basis taking account of their unique clinical circumstances. If the decision is made to replace an affected device St. Jude Medical will provide a replacement device at no cost.