Events

Avis De Sécurité sur FortifyTM , Fortify AssuraTM , Quadra AssuraTM, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™

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 St. Jude Medical.

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
    2016-10-10
  • 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
    Of the 398,740 devices sold worldwide, 841 were returned for analysis due to premature discharge battery, the formation of lithium "clusters" in the battery. at forty-six (46), clusters were seen which bridged the cathode and anode and caused a short circuit. lithium clustering is a well-known phenomenon in this type of battery.

Device

FortifyTM , Fortify AssuraTM , Quadra AssuraTM, Quadra Assura MP™, Unify™, Unify Assura™ and Unif...
  • Modèle / numéro de série
    CD1233-40 Fortify™ VR CD2233-40Q Fortify™ DR CD3251-40 Unify Quadra™ CD3361-40C Unify Assura™ CD1233-40Q CD2235-40 Fortify™ ST DR CD3251-40Q CD3361-40Q CD1235-40 Fortify™ ST VR CD2235-40Q CD3255-40 Unify Quadra MP™ CD3361- 40QC CD1235-40Q CD2259-40 Fortify Assura™ DR CD3255-40Q CD3367-40 Quadra Assura™ CD1259-40 Fortify Assura™ VR CD2259-40Q CD3261-40 Unify Assura™ CD3367-40C CD1259-40Q CD2299-40 HeartMinder™ ST DR CD3261-40Q CD3367-40Q CD1299-40 HeartMinder™ ST VR CD2299-40Q CD3267-40 Quadra Assura™ CD3367- 40QC CD1299-40Q CD2359-40 Fortify Assura™ DR CD3267-40Q CD3371-40 Quadra Assura MP™ CD1359-40 Fortify Assura™ VR CD2359-40C CD3271-40 Quadra Assura MP™ CD3371-40C CD1359-40C CD2359-40Q CD3271-40Q CD3371-40Q CD1359-40Q CD2359- 40QC CD3281-40 Excelis Quadra™ CD3371- 40QC CD1359-40QC CD2391-40C HeartMinder™ + DR CD3281-40Q CD3385-40C Quadra + Excelis™ CD1391-40C HeartMinder™ + VR CD2391- 40QC CD3297-40 Excelis™ CRT-D CD3385- 40QC CD1391-40QC CD3235-40 Unify™ CD3297-40Q CD3389-40C Excelis™ + CD2233-40 Fortify™ DR CD3235-40Q CD3361-40 Unify Assura™ CD3389- 40QC
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    AMPMDRS