Events

Alerte De Sécurité sur ICDs and CRT-Ds programmed with Merlin Programmer Software Version 17.2.2 rev. 0

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par St.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-01-28
  • Date de publication de l'événement
    2014-01-28
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140128.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: st. jude medical icds and crt-ds programmed with merlin programmer software version 17.2.2 rev. 0 the australia therapeutic goods administration (tga) posted a medical device safety alert concerning implantable cardioverter-defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds) programmed with merlin programmer software version 17.2.2 rev. 0, manufactured by st. jude medical. according to the manufacturer’s information, the affected models include current vr, current accel vr rf, current dr, current accel dr rf, promote, promote accel rf, promote quadra, analyst accel vr rf, analyst accel dr rf, fortify st vr, fortify st dr, fortify assura vr, fortify assura dr, ellipse vr, ellipse dr, unify, unify quadra, unify assura crt-d, quadra assura crt-d, and quadra assura mp crt-d. when using the 17.2.2 software and any parameter that is programmed as part of a single vf detection zone configuration, the sinus redetection value will be inappropriately set to zero milliseconds. as a result, any intrinsic activity following the first shock will be considered a “sinus rate” and the device will diagnose “return to sinus”. therefore, if the arrhythmia was not terminated by the initial high voltage therapy, the ongoing arrhythmia would be considered a new episode causing the next high voltage therapy to also be delivered at the first programmed energy level. the manufacturer advises users of the followings: review st jude medical icd/crt-d patient records for patients with affected devices implanted or seen in clinic starting in september 2013 and programmed to a single vf detection zone with the 17.2.2 software. for patients identified during this review, users should schedule an immediate follow-up visit. for patient devices programmed as described above with 17.2.2 software, st. jude medical will arrange installation of a new software version 17.2.3 to correct this issue. if a patient is seen before the 17.2.3 software is installed, then program the device to a two or three zone configuration, even if one of the zones is strictly a monitor zone. this will resolve the issue when using a programmer with 17.2.2 software. according to the local supplier, products with affected software version 17.2.2 were not distributed in hong kong. for details, please refer to tga websitehttp://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00034-1 if you are in possession of the product, please contact your supplier for necessary actions. posted on 28 january 2014.

Device

ICDs and CRT-Ds programmed with Merlin Programmer Software Version 17.2.2 rev. 0
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: St. Jude Medical ICDs and CRT-Ds programmed with Merlin Programmer
  • Manufacturer
    St

Manufacturer

St
  • 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
    DH