Events

Rappel de Viva ICD

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 and Heart Failure.

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
    74923
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2650-2016
  • Date de mise en oeuvre de l'événement
    2016-08-12
  • Date de publication de l'événement
    2016-08-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148794
  • 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
    78 viva crt -ds and evera icds that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. there have been seven (7) confirmed failures (9%) through july 16, 2016. reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
  • Action
    Consignees were sent or hand delivered on August 12, 2016 a Medtronic "Urgent Medical Device Correction" letter dated August 2016. The letter was addressed to Physician. The letter described the problem and the devices involved in the recall. The letter described a number of "Patient Management Recommendations". For questions contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.

Device

Viva ICD
  • Modèle / numéro de série
    Product Name: Viva XT CRT -D . Models: DTBA1D4, DTBA1D1. Serial Numbers:  BLF203128H, BLF204746H, BLE202888H, BLE202889H, BLE202890H, BLE202901H, BLE202941H, BLE202947H, BLE202954H, BLE202958H, BLE202961H, BLE202962H, BLE202964H, BLE202981H, BLE202987H, BLE202989H, BLE202990H, BLE202991H, BLE203019H, BLE203026H, BLE203027H, BLE203029H, BLE203032H, BLE203046H, BLE203052H, BLE203073H  Product Name: Viva S CRT-D. Models: DTBB1D4, DTBB1D1. Serial Numbers: BLO202272H, BLN202206H.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of US: AZ, CA, FL, GA, IL, KY, MD, MN, NJ, NY, NC, OH, OK, PA, PR, TX. and countries of: Australia, Finland, France, Germany, Iran, Italy, Japan, Korea, Netherlands, Puerto Rico, Saudi Arabia, Spain, and United Kingdom.
  • Description du dispositif
    Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: || Product Model || VIVAXTCRT-D DTBA1D1, DTBA1D4 || VIVASCRT-D DTBB1D1, DTBB1D4 || Product Usage: || The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT -D) is a multiprogrammable cardiac device that monitors and regulates the patients heart rate by providing single or dual chamber, rate responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies.
  • Manufacturer
    Medtronic Inc., Cardiac Rhythm and Heart Failure

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure
  • Adresse du fabricant
    Medtronic Inc., Cardiac Rhythm and Heart Failure, 8200 Coral Sea St NE, Mounds View MN 55112-4391
  • 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