Events

Rappel de Model 3200 programmer for Emblem, Emblem MRI and SQ-Rx Subcutaneous-Implantable Cardiac Defibrillators (S-ICDs)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Boston Scientific Pty Ltd.

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
    RC-2017-RN-00077-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-01-19
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00077-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    There is potential for radio frequency (rf) interference to alter wireless communication from the model 3200 programmer, which in rare instances may cause an s-icd to perform an unintended command, such as the unintended initiation of pg-based tachyarrhythmia induction of a patient, or a command that results in therapy being unavailable after the telemetry session has ended, both of which could result in patient death. this behaviour can only occur during an active, in-clinic interrogation/programming session with the model 3200 s-icd programmer. there is no risk of this behaviour occurring when the latitude patient management system communicates with an s-icd in an ambulatory setting. to date, a total of ten observations of unintended programming commands or data changes have been observed, with no instances of permanent injury or death.
  • Action
    Boston Scientific is developing software to mitigate this issue. Until updated software is available, recommendations that mitigate the risks associated with this issue, and which are detailed in the customer letter, are to be followed.

Device

Model 3200 programmer for Emblem, Emblem MRI and SQ-Rx Subcutaneous-Implantable Cardiac Defibrill...
  • Modèle / numéro de série
    Model 3200 programmer for Emblem, Emblem MRI and SQ-Rx Subcutaneous-Implantable Cardiac Defibrillators (S-ICDs) ARTG Number: 260383
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • 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
    DHTGA