Kappa 600/700/900 series and Sigma 100/200/300 series pacemakers 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.

Certain Kappa® and Sigma® series pacemakers may suffer sudden unexpected failure giving rise to bradycardia symptoms (fainting or light headedness). Serious injury or death may occur in pacemaker dependent patients.Medtronic has informed the MHRA that some Kappa® and Sigma® series pacemakers may fail at a higher than expected rate due to separation of wires within the pacemaker electronic circuitry. They issued a Field Safety Notice to address this problem in May 2009. Medtronic has confirmed that, in the UK, approximately 3,500 affected Sigma® and Kappa® pacemakers were distributed and has estimated that approximately 1,100 potentially affected pacemakers currently remain implanted. The 1,100 implants are estimated to represent approximately 2 % of all Kappa ® and Sigma® pacemakers implanted.The separation of the wires within these pacemakers may lead to premature battery depletion, loss of telemetry, loss of output or loss of rate response. This is a sudden pacemaker failure with no reliable means to predict when it may occur.Through post-market surveillance and manufacturing traceability studies, the manufacturer has identified certain pacemakers which may fail at a higher rate due to use of certain lots of a specific component. The manufacturer has yet to establish a specific root cause and is continuing to investigate.This Medical Device Alert also applies to a subset of the Sigma® devices which were already covered by the previous Medical Device Alert issued in December 2005 relating to the lifting of wire bonds due to the use of a cleaning solvent during the manufacturing process.Furthermore, a previous Kappa® advisory of March 2002 also involved the fracture of the wires connecting the electronic circuit to the power supply. However, Medtronic has confirmed that each of the root causes associated with these previous Sigma® and Kappa® advisories is different to that giving rise to the wire separation subject to this current Medical Device Alert.Medtronic has confirmed that the current number of failures reported worldwide represent 0.49 % and 0.88% of the affected Kappa® and Sigma® pacemaker populations respectively. However, the predicted failure rate due to this problem over the lifetime of these pacemakers is 1.1% for Kappa® and 4.8 % for Sigma. Most affected pacemakers have been implanted for five years or longer.