Events

Rappel de Device Recall Medtronic Marquis VR

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
    31142
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0597-05
  • Date de mise en oeuvre de l'événement
    2005-02-09
  • Date de publication de l'événement
    2005-03-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-12-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37239
  • 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
    Medtronic marquis family of icd and crt-d devices having batteries manufactured prior to december 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.
  • Action
    Medtronic Sales Representatives contacted affected physicians starting 02/10/05 to deliver an Important Patient Management Information. The letter recommended patient managment options including quarterly follow-ups, programming Patient Alert to 'On-High', provide magnet to patients to check device status and inform patients that should they expereicnce warmth in the area surrounding the ICD to seek prompt care.

Device

Device Recall Medtronic Marquis VR
  • Modèle / numéro de série
    Model 7230 Marquis VR (serial numbers listed include all affected devices but may include some unaffected devices. Patients are recommended to check with their doctor for exact serial numbers affected.) 7230B S-Series: PLW600001S - PLW600646S.  7230Cx H-Series: PKD100001H - PKD116584H, PKD117397H, PKD117553H, PKD117735H, and PKD117741H.  R-Series: PKD200084R - PKD200536R, PKD600016R - PKD600113R.  S-Series: PKD600009S - PKD608391S.  7230E S-Series: PLY600001S - PLY600749S and PLY600839S.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    worldwide
  • Description du dispositif
    Medtronic Marquis VR, model 7230 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.
  • 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