Events

Rappel de Merlinhome RF Remote Monitoring Transmitter Model EX1150

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par St Jude Medical Cardiac Rhythm Management Division.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    71995
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2784-2015
  • Date de mise en oeuvre de l'événement
    2015-08-18
  • Date de publication de l'événement
    2015-09-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139556
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Pulse generator, permanent, implantable - Product Code NVZ
  • Cause
    Some devices exhibit backup vvi operation due to a backup reset.
  • Action
    The notification material is in the form of a Physician Letter was delivered to physicians by FedEx overnight service. The mailing went out on August 17, 2015 for receipt on August 18, 2015. The firm's notification letter identifies clinical implications. Clinical Implications In the event that an Ellipse, Fortify Assura, Unify Assura, or Quadra Assura ICD enters the back-up safety mode, the nominal operational settings will be VVI pacing mode, 67 ppm, 5.0v/0.6ms with bipolar pacing output and defibrillation settings of aVF detection rate of 146 bpm and 36J high voltage therapy. In the event an Assurity or Allure pacemaker enters backup mode, it will have output settings of VVI pacing mode, 67 ppm, 5.0v/0.6ms with unipolar pacing. This anomaly can only occur when the patient is being actively monitored by a Merlin@home bedside transmitter. If a device enters backup mode, the ICD will deliver a patient vibratory alert and the pacemaker will deliver a patient audible alert. If backup operation is encountered, St. Jude Medical Technical Services (1-800-722-3774) can assist with non-invasively restoring the device to normal operation. The firm's notification also idenfities recommendations and mitigations. Recommendations and Mitigations Once available, a Merlin@home transmitter software update will be performed automatically over its telephone, broadband or cellular connection without requiring any action from you or your patients. No changes to the patients remote or in-clinic follow up schedules are required. In the event a patients device reverts to back-up mode, the firm recommends bringing the patient back in the clinic to clear the condition and return the device to full functionality. If you have any questions or concerns contact the local St. Jude Medical representative or St. Jude Medical's Technical Services Department.

Device

Merlinhome RF Remote Monitoring Transmitter Model EX1150
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) and foreign distribution to the following: Japan, France, Austria, Canada, Italy, Spain, Netherlands, South Africa, Great Britain, Australia, Sweden, Belgium, Finland, Germany, Portugal, Singapore, Norway, Poland, Ireland, Czech Republic. Denmark, Hong Kong, Saudi Arabia, Hungary, Switzerland.
  • Description du dispositif
    Merlin@home RF Remote Monitoring Transmitter Model EX1150. || Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
  • Manufacturer
    St Jude Medical Cardiac Rhythm Management Division

Manufacturer

St Jude Medical Cardiac Rhythm Management Division
  • Adresse du fabricant
    St Jude Medical Cardiac Rhythm Management Division, 15900 Valley View Ct, Sylmar CA 91342-3577
  • 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
    USFDA