Events

Rappel de Device Recall Lead Integrity Alert

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
    51135
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1172-2009
  • Date de mise en oeuvre de l'événement
    2008-11-03
  • Date de publication de l'événement
    2009-04-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78767
  • 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
    Automatic Implantable Cardioverter Defibrillator - Product Code LWS
  • Cause
    Medtronic has identified an issue related to installation or removal of the lead integrity alert software in entrust(r) and entrust(r) escudo" defibrillators. in those devices only, installation or removal of lia will inadvertently turn off two audible patient alerts.
  • Action
    Between November 24 and December 9, 2008 US CRDM are responsible to hand deliver the consignee letter, a Medtronic "Urgent Patient Management Information," dated November 2008, to impacted physicians to make them aware of the issue and continue to promote and install LIA (by using the new LIA tipcard). For any physician listed that a confirmation sheet was not received by end of day, December 9, 2008, the letter was mailed to the physician on Dec 10, 2008. The letter described the issue and the product involved. The letter also gave recommendations and informed consignees in regard to a future update to the LIA software for EnTrust devices.

Device

Device Recall Lead Integrity Alert
  • Modèle / numéro de série
    v1.0 software
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MI, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and countries of Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Lebanon, Macedonia, Martinique, Netherlands, Netherlands Antilles, Norway, Oman, Peru, Poland, Portugal, Puerto Rico, Qatar, Reunion, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom Vatican City State, Venezuela, and Virgin Islands.
  • Description du dispositif
    Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Managment
  • Adresse du fabricant
    Medtronic Inc. Cardiac Rhythm Managment, 8200 Coral Sea St. N.E., Mounds View MN 55112
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA