Events

Rappel de Device Recall INTELIS II pacemaker

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 Guidant Corporation.

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
    32681
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1038-05
  • Date de mise en oeuvre de l'événement
    2005-07-18
  • Date de publication de l'événement
    2005-07-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-01-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40562
  • 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 Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
  • Cause
    A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
  • Action
    INITIAL RECALL Urgent medical Device Safety Information & Corrective Action letter dated 07/18/05 was issued to physicians listing clinical Implications and patient management recommendations. EXPANDED RECALL Press was issued January 23, 2006. Urgent Medical Device Safety Information & Corrective Action letter, dated 01/21/06, was issued to physicians listing a summary of previous communication to physicians, advisory population update, and information relative to a second population of devices manufactured between October 19, 1998 and December 5, 2000. This letter gives the observed rate of occurrence, clinical implications, projected rate of occurrence and recommendations.

Device

Device Recall INTELIS II pacemaker
  • Modèle / numéro de série
    Affected devices may be contained in the following serial number ranges.  Model 1349: Serial numbers 100003 thru 100076. Model 1384: Serial numbers 300000 thru 300073. Model 1385: INITIAL RECALL serial numbers 400005 thru 400019. EXPANDED RECALL serial numbers 400003, 400004. Model 1483: Serial numbers 600005 thru 600082. Model 1484: Serial numbers 700005 thru 700064. Model 1485: INITIAL RECALL serial numbers 800005 thru 800053. EXPANDED RECALL serial numbers 800000, 800001, 800002, 800003, 800004. Model 1499: Serial numbers 200001 thru 200073.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cyprus, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guyana, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Polynesia, Portugal, Reunion, Russia, Saudi Arabia, Singapore,Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan ROC, Turkey, United Kingdom, Uruguay and Venezuela. EXPANDED RECALL additional countries include: China, Croatia, Korea. Lithuania, Madagascar, Maldives, Malta, Monaco, Nepal and Thailand.
  • Description du dispositif
    INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . INTELIS II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering both adaptive-rate therapy and conventional pacing therapy. These pacemakers provide various levels of therapeutic and diagnostic functionality. INTELIS II adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity.
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • Adresse du fabricant
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA