Events

Rappel de Medtronic Model 37751 Recharger, in Charging Systems used with implantable neurostimulators (INS) Charging System Models 37754 & 97754, used with spinal cord stimulation (SCS) devices:- Restore- RestoreUltra- RestoreAdvanced- RestoreSensor- RestoreUltra SureScan MRI- RestoreAdvanved SureScan MRI- RestoreSensor SureScan MRIRecharger in Charging System kit Model 37651, used with deep brain stimulation (DBS) device: - Medtronic Activa RC

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-2016-RN-01402-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-11-03
  • 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-2016-RN-01402-1
  • 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 has identified an increase in customer complaints about rechargers in an unresponsive error state, where the recharger is non-functional with a blank screen & beeping every 5 seconds. rechargers manufactured since november 2014 (serial # starting “nka4” or “nku4”) are more susceptible, with reports for 2% of these rechargers & 0.2% for those manufactured before november 2014. when the error occurs, the recharger is unable to recharge the neurostimulator until the recharger is reset. if the neurostimulator battery is allowed to become fully depleted, this can lead to loss of therapy and return of baseline pain levels and associated disease-specific symptoms. if the battery is allowed to remain fully depleted, it may over-discharge, affecting the battery capacity and the recharge frequency. for a subset of patients receiving dbs therapy, in rare instances, a loss of dbs therapy may result in a life threatening injury or death however no reports of this kind have been received.
  • Action
    Medtronic is working on a permanent solution and in the interim is providing the following workarounds: 1. To prevent the unresponsive error state, the Recharger should be plugged into the AC power supply (by aligning white triangles) prior to starting a recharging session of the neurostimulator and remain connected to the AC power supply until the recharging session has finished. Note: The AC power supply does not need to be plugged into a power outlet if the Recharger is charged. 2. To restore Recharger functionality if the unresponsive error state occurs, patients can contact Medtronic Neuromodulation Patient Services at 1800 652 972, or Customer Service on 1800 668 670, where they will receive instructions to reset their unresponsive Recharger. Treating physicians will also be provided with illustrated reset instructions with the customer letter. Patients should contact their physician immediately if they experience a return of symptoms. Note: This issue can recur after reset if the recharging instructions in point 1 are not completely followed.

Device

Medtronic Model 37751 Recharger, in Charging Systems used with implantable neurostimulators (INS)...
  • Modèle / numéro de série
    Medtronic Model 37751 Recharger, in Charging Systems used with implantable neurostimulators (INS)Charging System Models 37754 & 97754, used with spinal cord stimulation (SCS) devices:- Restore- RestoreUltra- RestoreAdvanced- RestoreSensor- RestoreUltra SureScan MRI- RestoreAdvanved SureScan MRI- RestoreSensor SureScan MRIRecharger in Charging System kit Model 37651, used with deep brain stimulation (DBS) device: - Medtronic Activa RCARTG Number: 121279
  • Classification du dispositif
    Neurological 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