Events

Rappel de Device Recall Sigma 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 Medtronic Inc. Cardiac Rhythm Managment.

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
    34093
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0536-06
  • Date de mise en oeuvre de l'événement
    2005-11-29
  • Date de publication de l'événement
    2006-02-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-01-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43289
  • 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 Pacemaker Pulse-Generator - Product Code DXY
  • Cause
    An issue exists with a specific subset of sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. this failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. there have been no reported patient injuries or deaths due to this issue.
  • Action
    Press Release was issued 11/29/05. Hospital/physician letters sent via registered mail on 11/29/05 for delivery on 12/01/05. Unimplanted devices are being retrieved. The Physician letter describes the issue, root cause, the probability of reoccurrence and provides recommendations. A list of affected serial numbers that the physician is following or has implanted is attached to the letter. The letter also provides medtronic's website in which regular updates on the ongoing actual performance are listed in their Product Performance Report. Medtronic is providing a replacement device should the Physician and patient elect to replace the affected implanted device.

Device

Device Recall Sigma Pacemaker
  • Modèle / numéro de série
    Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com.  Model SVDD303: serial no. PJD183400H - PJD183447H, PJD186130H - PJD186199H, PJD188418H - PJD188519H, PJD430299H - PJD430332H, PJD441378H - PJD441396H, PJD442436H - PJD442448H, PJD445371H - PJD448139H, PJD675113S - PJD675193S, PJD675694S - PJD676809S, PJD677182S - PJD677945S, PJD678157S - PJD686906S, PJD730001S - PJD744349S.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
  • Description du dispositif
    Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacing Pacemaker. Atrial Bipolar sensing connector, ventricular Bipolar connector, model SVDD303.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Managment
  • Adresse du fabricant
    Medtronic Inc. Cardiac Rhythm Managment, 7000 Central Ave Ne, Fridley MN 55432
  • Source
    USFDA