Events

Rappel de POCKET ADAPTOR KIT FOR DEEP BRAIN STIMULATION

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDTRONIC OF CANADA 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
    60062
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-06-23
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Notification communicates recent results from returned product analysis of medtronic neuromodulation deep brain stimulation (dbs) system pocket adaptors with reports of high impedances and reinforces device labeling specific to the handling of pocket adaptors and system integrity checking during implant procedures. medtronic has identified sixteen (16) dbs pocket adaptors that were returned for high impedance measurements and where subsequent medtronic analysis identified conductor wire fractures in close proximity to the location where the adaptor wire exits the neurostimulator connector block. notification raises awareness of current product labeling that could reduce potential for pocket adaptor conductor wire fractures or increase detection of an issue during the implant procedure.

Device

POCKET ADAPTOR KIT FOR DEEP BRAIN STIMULATION
  • Modèle / numéro de série
    Model Catalog: 64001 (Lot serial: All lots); Model Catalog: 64002 (Lot serial: All lots)
  • Description du dispositif
    POCKET ADAPTOR KIT FOR DEEP BRAIN STIMULATION
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Adresse du fabricant
    BRAMPTON
  • 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
    HC