Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) 에 대한 현장 안전성 서한

Field Safety Notice

2017-07-24

Slovenia

AMPMDRS

1. an electronic component used in a specific hardware version of platinium devices has been found to be sensitive to electrostatic discharge (esd) potentially generated during the implant surgery. the discharge can trigger overconsumption of current, leading to reduced device longevity (5% longevity loss per month). the overconsumption is detectable upon interrogation of the device during follow-up visit and it can be stopped by resetting the device. although the overconsumption is stopped after this reset, the residual longevity displayed by the programmer may temporarily be underestimated. 2. although platinium devices are not currently approved as mri conditional and are therefore contraindicated for mri, livanova is aware that some patients implantedwith a platinium device have undergone an mri scan based upon medical judgment weighing the benefits and risks of the procedure. when exposure to an mri’s magnetic field occurs, overconsumption can occur and the battery voltage will decrease to 2.80v. at this level, the device remaining longevity is 25% of the initial longevity. neither of the issues described above affect the therapeutic functions of the device. all sensing, pacing and shock delivery capabilities will remain functional. .