Events

Rappel de Device Recall Angeion Sentinel ICD

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 ela Medical Llc.

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
    31539
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0801-05
  • Date de mise en oeuvre de l'événement
    2005-01-25
  • Date de publication de l'événement
    2005-05-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-07-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38111
  • 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
    A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750v charge times and disable the device's ability to report an end of life (eol) indicator due to excessive charge times unless the patient is receiving periodic 750v therapy shocks.
  • Action
    Angeion notified physicians responsible for managing each remaining implanted ICD, also provided them with programming means to change the automatic cap charging schedule, and to monitor and document the reprogramming process.

Device

Device Recall Angeion Sentinel ICD
  • Modèle / numéro de série
    AK630187, AK630131, AK630076, AK630290, AK630173, AK630115, AK730368, AK630130, AK630167, AK630099, AK630106, AK730377, AK730393, AK730443, AK730363, AK630157, AK730442, AK630026, AK630135, AK630102, AK630226, AK630142., AK730431, AK630185, AK630137, AK630230, AK630147, AK630015, AK630030, AK630197, AK630098, AK730448, AK630090, AK630265, AK630160, AK730455, AK730381, AK630146 OUS codes:AK630029, AK630043, AK630045, AK630046, AK630048, AK630055, AK630066, AK630067, AK630069, AK630072, AK630073, AK630075, AK630078, AK630080, AK630083, AK630101, AK630104, AK630108, AK630111, AK630112, AK630121, AK630129, AK630154, AK630155, AK630172, AK630174, AK630175, AK630178, AK630186, AK630199, AK630207, AK630216, AK630221, AK630223, AK630231, AK630247, AK630280, AK630281, AK630283, AK630284, AK630296, AK630297, AK630298, AK630299, AK730435, AK730439, AK730441.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina.
  • Description du dispositif
    Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.
  • Manufacturer
    ela Medical Llc

Manufacturer

ela Medical Llc
  • Adresse du fabricant
    ela Medical Llc, 2950 Xenium Ln N Ste 120, Plymouth MN 55441-2623
  • Source
    USFDA