Events

Rappel de Device Recall Optisure HV lead

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 St Jude Medical Cardiac Rhythm Management Division.

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
    72569
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0660-2016
  • Date de mise en oeuvre de l'événement
    2015-11-03
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141537
  • 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
    Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the svc shock coil.
  • Action
    An Important Medical Device Advisory letter was sent to doctors on 11/3/15 to inform them of the recall by St. Jude Medical. The letter informs the doctors that St. Jude Medical identified that during the manufacturing process of a limited number of Optisure leads, a trim technique to remove excess medical adhesive around the SVC shock coil may have introduced damage to the leads insulation. The letter provides the doctors with the recommendations for patients with a potentially impacted Optisure lead connected to a device with Dynamic TX technology and for patients implanted with a potentially impacted Optisure lead connected to a device without DynamicTx technology. Doctors with questions about the advisory are instructed to contact their local Sales Representative or St. Jude Medical Technical Services at (800) 722-3774.

Device

Device Recall Optisure HV lead
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    BRE010002 BRE010016 BRE010032 BRE010033 BRE010034 BRE010035 BRE010037 BRE010039 BRE010040 BRE010042 BRE010044 BRE010046 BRE010062 BRE010066 BRE010075 BRE010077 BRE010082 BRE010096 BRE010097 BRE010098 BRE010099 BRE010165 BRE010166 BRE010173 BRE010183 BRE010185 BRE010191 BRE010194 BRE010195 BRE010205 BRE010208 BRE010215 BRE010220 BRE010226 BRE010232 BRE010235 BRE010240 BRE010241 BRE010258 BRE010299 BRE013300 BRE013302 BRG010102 BRG010103 BRG010116 BRG010174 BRG010178 BRG010179 BRG010188 BRG010205 BRG010206 BRG010207 BRG010213 BRG010232 BRG010233 BRG010237 BRG010238 BRG010246 BRG010247 BRG010248 BRG010249 BRG010250 BRG010264 BRG010285 BRG010298 BRG010350 BRG010383 BRG010396 BRG010404 BRG010405 BRG010411 BRG010415 BRG010574 BRG010619 BRG010625 BRG010658 BRG010664 BRG010684 BRG010721 BRG010722 BRG010723 BRG010770 BRG010812 BRG010814 BRG010818 BRG010820 BRG010821 BRG010822 BRG010937 BRG010938 BRG010939 BRG010946 BRG010947 BRG010967 BRG010978 BRG010979 BRG010982 BRG010983 BRG010992 BRG010993 BRG010998 BRG010999 BRG011013 BRG011016 BRG011057 BRG011085 BRG011300 BRG011301 BRG011302 BRG011306 BRG011307 BRG011318 BRG011326 BRG011512 BRH010166 BRH010167 BRH010168 BRH010174 BRH010175 BRH010187 BRH010190 BRH010197 BRH010198 BRH010307 BRH010310 BRH010348 BRH010352 BRH010361 BRH010373 BRH010387 BRH010391 BRH010401 BRH010402 BRH010421 BRH010428 BRH010439 BRH010442 BRH010445 BRH010454 BRH010455 BRH010497 BRH010518 BRH010519 BRH010522 BRH010523 BRH010538 BRH010549 BRH010550 BRH010574 BRH010603 BRH010607 BRH010644 BRH010645 BRH010658 BRH010711 BRH010794 BRH010801 BRH010802 BRH010823 BRH010834 BRH010849 BRH010863 BRH010866 BRH010871 BRH010872 BRH010873 BRH010881 BRH010886 BRH010887 BRH010893 BRH010905 BRH010906 BRH010916 BRH010917 BRH010927 BRH010931 BRH010963 BRH010964 BRH010970 BRH010972 BRH010980 BRH010982 BRH011002 BRH011003 BRH011004 BRH011005 BRH011015 BRH011016 BRH011018 BRH011019 BRH011021 BRH011023 BRH011024 BRH011025 BRH011058 BRH011059 BRH011060 BRH011061 BRH011067 BRH011069 BRH011071 BRH011078 BRH011093 BRH011094 BRH011095 BRH011096 BRH011100 BRH011110 BRH011113 BRH011126 BRH011127 BRH011128 BRH011129 BRH011133 BRH011146 BRH011147 BRM010031 BRM010034 BRM010036 BRM010037 BRM010047 BRM010050 BRM010051 BRM010055 BRM010062 BRM010065 BRM010067 BRM010076 BRM010086 BRM010099 BRM010282 BRM010283 BRM010285 BRM010286 BRM010288 BRM010291 BRM010306 BRM010309 BRM010314 BRM010316 BRM010318 BRM010320 BRM010322 BRM010326 BRM010335 BRM010336 BRM010339 BRM010340 BRM010345 BRM010346 BRM010352 BRM010354 BRM010355 BRM010357 BRM010363 BRM010364 BRM010367 BRM010368 BRM010369 BRM010371 BRM010375 BRM010380 BRM010381 BRM010382 BRM010383 BRM010384 BRM010385 BRR010065 BRR010093 BRR010116 BRR010120 BRR010121 BRR010340 BRR010344 BRR010347 BRR010353 BRR010354 BRR010355 BRR010356 BRR010357 CXM100037 BRE010159 BRE010286 BRE010288 BRG010029 BRG010030 BRG010036 BRG010037 BRG010041 BRG010042 BRG010044 BRG010049 BRG010050 BRG010051 BRG010060 BRG010067 BRG010068 BRG010069 BRG010070 BRG010077 BRG010082 BRG010087 BRG010088 BRG010105 BRG010133 BRG010161 BRG010162 BRG010164 BRG010166 BRG010177 BRG010181 BRG010220 BRG010231 BRG010300 BRG010302 BRG010303 BRG010311 BRG010316 BRG010317 BRG010335 BRG010340 BRG010372 BRG010374 BRG010375 BRG010407 BRG010421 BRG010423 BRG010436 BRG010437 BRG010438 BRG010456 BRG010462 BRG010492 BRG010493 BRG010494 BRG010499 BRG010502 BRG010536 BRG010539 BRG010610 BRG010615 BRG010624 BRG010644 BRG010646 BRG010648 BRG010654 BRG010659 BRG010669 BRG010674 BRG010676 BRG010679 BRG010686 BRG010687 BRG010691 BRG010693 BRG010706 BRG010707 BRG010754 BRG011022 BRG011109 BRG011116 BRG011124 BRG011141 BRG011149 BRG011150 BRG011156 BRG011157 BRG011158 BRG011160 BRG011161 BRG011172 BRG011182 BRG011198 BRG011199 BRG011478 BRH010161 BRH010172 BRH010173 BRH010184 BRH010226 BRH010232 BRH010241 BRH010242 BRH010270 BRH010282 BRH010283 BRH010288 BRH010306 BRH010336 BRH010382 BRH010429 BRH010438 BRH010444 BRH010446 BRH010500 BRH010521 BRH010543 BRH010566 BRH010568 BRH010581 BRH010585 BRH010600 BRH010602 BRH010614 BRH010622 BRH010624 BRH010625 BRH010626 BRH010627 BRH010631 BRH010632 BRH010634 BRH010646 BRH010647 BRH010665 BRH010666 BRH010667 BRH010686 BRH010764 BRH010766 BRH010767 BRH010921 BRH011458 BRH011459 BRH011460 BRH011474 BRH011475 BRH011476 BRH011487 BRH011498 BRH011502 BRH011503 BRH011505 BRH011512 BRH011518 BRH011523 BRH011525 BRH011546 BRH011547 BRH011549 BRH011642 BRH011652 BRL010010 BRP010075 BRP010076 BRP010077 BRP010125
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution US (nationwide), Belgium, Switzerland, Germany, France, United Kingdom, India, Italy, Japan, Luxembourg, The Netherlands, Saudi Arabia, and Sweden.
  • Description du dispositif
    Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
  • Manufacturer
    St Jude Medical Cardiac Rhythm Management Division

Manufacturer

St Jude Medical Cardiac Rhythm Management Division
  • Adresse du fabricant
    St Jude Medical Cardiac Rhythm Management Division, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA