Events

Rappel de Medtronic RestoreSensor 37714 Neurostimulators

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Medtronic Inc.

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
    16080
  • Date de mise en oeuvre de l'événement
    2014-01-30
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • Cause
    1) unexpected loss of stimulation may occur under the following conditions: - switching from a group with two programs to a group with three or four programs where a non-negative contact is shared within the programmed groups. - creating program groups (activa sc only) when a second program is created for the first time. 2) under a specific set of conditions (activa sc - models 37602 / 37603 are not affected), typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended: - device reaches a power on reset (por) state. a por may be detected during interrogation with the patient or physician programmer. the patient will experience loss of therapy if a por occurs. - 'therapy off' command is sent (by patient programmer, insr, or 'therapy-stop' button on the 8840 clinician programmer) to device while the device is making an automatic periodic battery measurement.
  • Action
    Software to be upgraded

Device

Medtronic RestoreSensor 37714 Neurostimulators
  • Modèle / numéro de série
    Model: Models 37714, Affected:
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • 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
    NZMMDSA