Events

Rappel de Device Recall SJM Confirm, Implantable Cardiac Monitor (ICM)

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 CRMD.

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
    58686
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2733-2011
  • Date de mise en oeuvre de l'événement
    2011-03-31
  • Date de publication de l'événement
    2011-07-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99926
  • 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 Cardiac Monitor (without arrythmia detection) - Product Code MXC
  • Cause
    The recall was initiated because st. jude medical made new software available for the sjm confirm dm2100 implantable cardiac monitor (icm) that incorporates enhancements to the devices sensing algorithm. these enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. the user is presented with the option to upgrade new software into the sjm confirm icm.
  • Action
    St. Jude Cardiac Rhythm Management Division sent an "Important Product Correction" letter on March 25, 2011 to all affected customers. The letter explains the reason for the recall and provided recommendations including a software upgrade by SJM Field Clinical Engineer or Technical Services. Customers were recommended to fill out and return a "Physician Acknowledgement Form". For additional information please contact your local St.Jude Medical Sales Representative, Field Clinical Engineer or the Technical Services Department at 800-722-3774

Device

Device Recall SJM Confirm, Implantable Cardiac Monitor (ICM)
  • Modèle / numéro de série
    Confirm DM2100, DM2102 (IDE). Software Version 10.1.1.2
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: (USA) Nationwide including the States of CA, WA, FL, WV, NY, MD and LA, and the country of Germany
  • Description du dispositif
    SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). || This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia
  • Manufacturer
    St Jude Medical CRMD

Manufacturer

St Jude Medical CRMD
  • Adresse du fabricant
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA