Events

Field Safety Notices about Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by LivaNova PLC.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-07-24
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    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. .

Device

Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibri...

Manufacturer

LivaNova PLC