Events

Avis De Sécurité sur Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par LivaNova PLC.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2017-07-24
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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