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
    59421
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3183-2011
  • Date de mise en oeuvre de l'événement
    2011-05-25
  • Date de publication de l'événement
    2011-09-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-12-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102726
  • 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
    Boston scientific has identified two occurrences where the latitude system did not process a data payload, which is the information uploaded to the latitude system from a remote interrogation of the implanted device. these occurrences resulted in non-displayed payloads because the data is not posted to the website. if the payload is not displayed, the pertinent data will not be available on the.
  • Action
    Boston Scientific notified all affected customers by telephone on May 25, 2011. The customers were informed that there was an interrogation for one of their patients that was not able to be displayed on the website. Boston Scientific detected that a payload failure had occurred, but could not conclude what information was contained within the payload. Each patient has had previous and subsequent payloads that have processed and displayed on the LATITUDE website.

Device

Device Recall LATITUDE Patient Management System Communicator
  • Modèle / numéro de série
    SN 035074 SN 032915
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution-in the states of Florida and Texas.
  • Description du dispositif
    LATITUDE¿ Patient Management System Communicator, Model 6482. || The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible 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