Events

Rappel de Device Recall Guidant VITALITY AVT

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
    35525
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1291-06
  • Date de mise en oeuvre de l'événement
    2006-05-15
  • Date de publication de l'événement
    2006-07-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-03-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46339
  • 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 - Product Code LWP
  • Cause
    Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. if function of this low voltage capacitor is compromised, the battery may deplete prematurely.
  • Action
    An Urgent Medical Device Safety Information & Corrective Action letter, dated May 12, 2006, was sent to physicians. The letter gave a description of the issue, clinical implications, rate of occurrence, devices affected and recommendation. Physicians are asked to follow-up with affected patients as soon as possible because ERI to EOL time may be shortened. Physicians are asked to contact Guidant for instructions on performing a baseline 'save to disk' and provide this information to Guidant. Guidant will be able to analyze the device memory data and estimate remaining longevity and provide individualized follow-up and replacement guidelines. Subsequent follow-up visits should continue to monitor for evidence of premature battery depletion.

Device

Device Recall Guidant VITALITY AVT
  • Modèle / numéro de série
    model A155, serial numbers: 113567, 113568, 113569, 113570, 113572, 113574, 113585, 113586, 113587, 113591,  113612, 113613, 113616, 113617, 113618, 113619, 113620,  113621, 113623, 113624, 113626, 113627, 113628, 113629,  113631, 113633, 113635, 113637, 113639, 113640, 113641,  113654, 113659, 113660, 113672, 113674, 113675, 113676,  113678, 113679, 113680, 113681, 113682, 113684, 113686,  113687, 113690, 113693, 113694, 113695, 113696, 113778,  113779, 113781, 113783, 113784, 113789, 113791, 113792,  113814, 113908, 113910, 113912, 113913, 113914, 114083
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide including Puerto Rico. Worldwide, including Argentina, Belgium, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Portugal, Spain, Syrian Arab Republic, United Arab Emirates
  • Description du dispositif
    VITALITY AVT, model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
  • 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