Implantable cardioverter defibrillators (ICD) 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.

Risk of loss of ICD/pacing therapy after elective replacement indicator (ERI) is reached, due to rapid battery depletion occurring approximately two and an half years after implantation.Approximately 69,000 EnTrust devices have been sold worldwide since 2005, with just over 1,000 sold in the UK. To date only 0.15% of single chamber EnTrust ICDs and 0.04% of dual chamber EnTrust ICDs worldwide are reported to have experienced rapid voltage decline. Although the issue does not appear to affect devices implanted for less than 30 months, the failure rate as implant duration increases is as yet unknown.Medtronic issued a Field Safety Notice (38Kb) addressing this issue on 6 March 2012.Fig 1: Medtronic’s analysis of ICD failures
The graph shows examples of a number of ICDs which have experienced rapid voltage drop from 3.0V to 2.61V over a time period ranging from approximately one week to six months.  
Note:  This graph may not be characteristic of every possible voltage curve drop due to this issue.  The sole purpose of this graph is to illustrate rapid voltage decline to 2.61V (ERI), not the duration of time between ERI and EOL.End of life (EOL) is triggered 90 days after ERI or after two excessive charge time events (>16 seconds) or if the battery voltage is 2.55V.In EnTrust devices that experienced rapid voltage decline, time between measurements of approximately 3.0V and 2.61V (ERI) ranged from four to 198 days (mean 71, median 56).In EnTrust devices that experienced rapid voltage decline, time between ERI and EOL ranged from six to 96 days (mean 41, median 26), based upon data available from the 9 ICDs that experienced charge circuit timeout events during automatic capacitor formation prior to device explant.In the event of a battery short circuit the ICD may not be able to provide the required therapy for the three month period generally expected post ERI. Although incidents of charge circuit timeout have occurred, there have been no reports to date of death or serious injury associated with this failure.The rapid voltage drop has been linked to an internal short circuit within the ICD battery.  Although the exact root cause is still being investigated by the manufacturer, the issue appears to be specific to EnTrust devices.  Failure rate data for other Medtronic ICD models incorporating the same battery model currently indicate that they are not affected.  Furthermore, these batteries are not used by other manufacturers.