Events

Rappel de Device Recall Cardiac Resynchronization Therapy Defrillator

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
    51345
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1620-2009
  • Date de mise en oeuvre de l'événement
    2009-03-04
  • Date de publication de l'événement
    2009-07-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80056
  • 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
    Pulse-generator, dual chamber, implantable - Product Code LWP
  • Cause
    In april 2007, boston scientific crm communicated with physicians regarding the potential for reduced elective replacement indicator (eri) to battery end of life (eol) time in a subset of implantable defibrillators due to degradation of a low-voltage capacitor. since that time, the april 2007 advisory population has not experienced any clinically significant changes to either the rate of occurrenc.
  • Action
    Boston Scientific CRM notified Doctors via sales representatives of an "Urgent Medical Device Information" letter dated March 4, 2009. The letter described the problem and included Description of Issue, Rate of Occurrence, Patient Management Recommendations, Devices Affected, Warranty Program & Further Information. A Boston Scientific " Product Advisory" letter dated March 4, 2009, was also made available to physicians to distribute to patients. The letter informed the patient that their defibrillator was included in a group of devices that might experience a performance issue. For further questions, Contact Boston Scientific CRM at 1-800-227-3422.

Device

Device Recall Cardiac Resynchronization Therapy Defrillator
  • Modèle / numéro de série
    SERIAL NUMBERS FOR MODEL #H170 :  361904, 363420, 363895, 364293, 364294, 364349, 364350, 364470, 364480, 364485, 364486, 364494, 364510, 364539, 364617 and 364621; and  SERIAL NUMBERS MODEL #H175:  312616, 312962, 312965, 312973, 313064, 315207, 315209, 315212, 315213, 315219, 315227, 315238, 315248, 315251, 315265, 315398, 315431, 315446, 316045, 316064 and 316123; and  SERIAL NUMBERS MODEL #H177:  281692, 282937, 284803, 284874, 284896, 285009, 285019, 285091, 285110, 285111, 285120, 285134 285332 and 285357; and  SERIAL NUMBERS MODEL #H179:  111439, 112977, 113822, 113910, 114275, 114375, 114394, 114488, 114503, 114506, 114515, 114523, 114652, 114680, 114682 and 114714; and  SERIAL NUMBERS MODEL #H190:  312166, 311764, 311803, 311894, 312164 and 312177; and  SERIAL NUMBERS MODEL #H195:  352084, 353252, 353389, 351230, 353157 and 353388; and  SERIAL NUMBERS MODEL #H197:  310113, 310253, 310651, 310335, 310337, 310339, 310342, 310357, 310361, 310442, 310464, 310465, 310518, 310660, 310691, 310696, 310814, 310933 and 311096; and  SERIAL NUMBERS MODEL #H199:  321405, 321060, 321415, 321423, 321478, 321489, 321494, 321498 and 321689; and  SERIAL NUMBERS MODEL #M177:  200050 and 200051; and  SERIAL NUMBERS MODEL #M179:  200098, 200099 and 200033.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US including PR and states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and WY and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, JAPAN, LEBANON, NETHERLANDS, NEW ZEALAND, POLYNESIA, PORTUGAL, SPAIN, SWITZERLAND, TURKEY and UNITED KINGDOM.
  • Description du dispositif
    Guidant Contak¿ Renewal¿ 3 CRT-D Model H170; 3CRT-D, Model H175; 3HE CRT-D, Model H177; 3HE CRT-D, Model H179; 4CRT-D REF H190; 4CRT-D REF H195; 4HE CRT-D REF H197; 4HE CRT-D REF H199; 4AVT CRT D, REF M177; 4AVT HE CRT-D REF 179. Cardiac Resynchronization Therapy Defibrillator, Sterile EO, Guidant Corporation, 4100 Hamline Avenue North, St Paul, MN 55112-5798. || Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
  • 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