Events

Avis De Sécurité sur SynchroMed® II and SynchroMed EL Implantable Drug Pumps

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Medtronic Limited.

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
  • Numéro de l'événement
    SN2013(07)
  • Date
    2013-07-11
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/synchromed-ii-and-synchromed-el-implantable-drug-pumps&id=5a7bf825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    Four communications to help identify and manage issues that may impact the safe delivery of therapy using the synchromed® ii and synchromed el implantable drug pumps.
  • Action
    The IMB recommends that:  1. Relevant personnel in your organisation are made aware of these potential issues.  2. The device and patient management advice outlined in the Medtronic Communications is followed.  3. Unused sutureless connector catheters with a used by date prior to 25th August 2014 should be returned to Medtronic.  4. This IMB Safety Notice and the attached Field Safety Notices are passed on to any organisation or end user where the potentially affected devices have been transferred.

Device

SynchroMed® II and SynchroMed EL Implantable Drug Pumps

Manufacturer

Medtronic Limited
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HPRA