Teligen and Cognis defibrillators 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.

For devices implanted subpectorally there are risks of:loss of shock therapy
inappropriate shock therapy
loss of pacing therapy
loss of anti-tachycardia pacingThe manufacturer has established that the bond between the header and case of these specific models can be weakened either from significant forces associated with a subpectoral implant procedure or when a device in a subpectoral position is repeatedly pushed against a rib during contraction of the pectoralis muscle.The following factors may have an impact on the risk of failure if affected devices are implanted subpectorally:exact location of the patient’s ribs relative to the device
body size and/or muscle mass of the patient (risk increases for larger or muscular patients)
activity level and/or occupation of the patient (risk increases for more active patients)
increased implantation duration.The manufacturer issued a Field Safety Notice in December 2009 informing clinicians about this issue.
The manufacturer has confirmed that approximately 2,500 affected Teligen and Cognis devices have been distributed on the UK market since these models were released in June 2008. They have estimated that approximately 5% of affected devices are implanted subpectorally worldwide. Devices implanted subcutaneously are not included in this advisory.To date the manufacturer has confirmed two (non-UK) reports of device malfunction associated with this issue out of approximately 77,000 devices sold worldwide. Both devices required early replacement (at four and five months post-implant) as they had delivered inappropriate shocks. The manufacturer has not identified a mean time-to-failure for this problem.