Events

Rappel de Percepta CRT-P MRI SureScan (W1TR04) and Percepta Quad CRT-P MRI SureScan (W4TR04)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia 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-2018-RN-00831-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-07-05
  • 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-2018-RN-00831-1
  • 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
    Medtronic have identified that when an ap-vs interval measures 100-109ms during a short, nightly device check, a single reset is generated. this reset produces a non-programmable, wireless carealert, but does not alter device therapy. if the device experiences more than five resets due to this timing sequence between in-clinic device interrogations, a full reset (sometimes referred to as a power on reset) will occur. by design, a full reset automatically reverts device operation to rv-only pacing at vvi/65 until the next programmer session is conducted – at which time the full reset condition can be cleared, and the device can be reprogrammed to its prior settings.
  • Action
    Medtronic are advising that a software update, Application SW040 Version 8.1, is available for installation onto all CareLink Model 2090 and Encore programmers to eliminate this issue. Once installed, an in-clinic device interrogation will update the patient's device automatically to prevent this timing interaction from generating a reset. Surgeons are advised: - To contact their local Medtronic Representative to schedule installation of the updated Percepta CRT-P Application Software onto Medtronic 2090 and Encore Programmers. - For a patient who has been implanted with a Percepta CRT-P device, consider scheduling an in-clinic device interrogation as soon as possible following installation of the updated application software, for the patient’s device to receive the automatic update.

Device

Percepta CRT-P MRI SureScan (W1TR04) and Percepta Quad CRT-P MRI SureScan (W4TR04)
  • Modèle / numéro de série
    Percepta CRT-P MRI SureScan (W1TR04) and Percepta Quad CRT-P MRI SureScan (W4TR04)ARTG Numbers: 291818 (Medtronic Australasia Pty Ltd - Percepta CRT-P MRI SureScan W1TR04 - Biventricular pacemaker)291819 (Medtronic Australasia Pty Ltd - Percepta Quad CRT-P MRI SureScan W4TR04 - Biventricular pacemaker)
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA