Events

Rappel de Device Recall ESSENTIO MRI DR Pacemaker

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 Corporation.

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
    78787
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0370-2018
  • Date de mise en oeuvre de l'événement
    2017-12-07
  • 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=160534
  • 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 pulse generator, pacemaker (non-CRT) - Product Code LWP
  • Cause
    Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
  • Action
    On December 19, 2017 the firm sent a letter to all their medical consignees stating the following: December 2017 Dear Doctor, Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude (Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV). Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems. Root Cause Investigation The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A. Engineering analysis and

Device

Device Recall ESSENTIO MRI DR Pacemaker
  • Modèle / numéro de série
    Model L111
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    AK, AL, AR, AZ, CA , CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico Worldwide
  • Description du dispositif
    ESSENTIO MRI DR Pacemaker
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 4100 Hamline Ave N Bldg 3, Saint Paul MN 55112-5700
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA