Ellipse™ VR/DR implantable cardioverter defibrillators (ICDs) 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.

Potential for delayed or insufficient energy defibrillation therapy due to a capacitor fault.St Jude Medical issued a FSN dated 19 August 2014 (340Kb), describing a potential failure mode which can delay or reduce the therapy that can be delivered by the ICD. The problem has been traced to an ICD capacitor defect, accompanied in some returned devices with evidence of arcing between the capacitor anode and cathode. Analysis so far indicates that it is not possible to predict which ICDs will suffer this failure or when it may occur, so despite a low failure rate of 0.42%, all patients and clinicians will need to be vigilant.All affected ICDs will exhibit extended charge times, evident not only during device testing / maintenance but also when preparing to deliver therapy. To date all potential failures reported to St Jude Medical have been identified through timeout warnings triggered by automated capacitor maintenance or during in-clinic testing, rather than being associated with serious adverse events.The manufacturer has confirmed that all affected ICDs should now have been retrieved from hospital supplies and they are currently replacing them with newly designed product not expected to be susceptible to this failure mode. Replacement product can be identified according to the serial numbers detailed at the end of the FSN, and by the green label fixed to the ICD packaging.Affected devices have in most cases ‘recovered’ and perform normally after an extended charge timeout. From bench testing of returned devices, the manufacturer has confirmed that the likelihood of the ICD continuing to perform normally after an extended charge timeout is far greater among those ICDs with capacitors manufactured since a process improvement at the start of August 2012 (93% recovery), compared to those manufactured before (50% recovery).St Jude Medical will be able to provide advice for ICDs exhibiting extended charge times on whether the device incorporates the earlier or later more reliable capacitors. Subsequent automated or manual capacitor testing should also help demonstrate whether there is a persistent problem following an initial timeout event. In-clinic testing and reducing the capacitor maintenance interval to every 4 months (from the standard 6-monthly interval) will enable earlier detection of a possible problem, but it is important to be aware that their combined effect will reduce the remaining device longevity by almost 20%. Clinicians should take this into account in their management of individual patients.Any device that has experienced repeated, extended charge timeout warnings should be considered for replacement. Prophylactic explant is not generally recommended, but may need to be considered in exceptional circumstances such as for very high-risk patients, or those unable to cope with the psychological effects of this issue.