Events

Rappel de Device Recall LATITUDE Patient Management System Communicator

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 Boston Scientific CRM Corp.

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
    61107
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1135-2012
  • Date de mise en oeuvre de l'événement
    2012-01-19
  • Date de publication de l'événement
    2012-03-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107311
  • 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
    Implantable cardioverter defibrillator (non-crt) - Product Code LWS
  • Cause
    One (1) model 6476 latitude communicator is unable to interrogate the patient's pulse generator. boston scientific has determined that this is due to a patient receiving an incorrect communicator. therefore the communicator did not find and was unable to interrogate the assigned patients pg. additionally when the patient attempted to set-up this incorrect communicator, the system reflected.
  • Action
    On January 19, 2012 Boston Scientific telephoned the affected patient and their clinic. The patient was notified that the communicator they received will not be able to activate successfully and that their communicator and sensors would be replaced. The clinician was informed of the patient's communicator was sent incorrectly to the other patient who attempted to activate it, the monitored status of the website was incorrect and that a new communicator would be shipped to the patient that will work with their device.

Device

Device Recall LATITUDE Patient Management System Communicator
  • Modèle / numéro de série
    SN 224453
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution: UT only.
  • Description du dispositif
    Boston Scientific, LATITUDE¿ Patient Management System Communicator, Models 6476. || The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • Adresse du fabricant
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA