Events

Recall of REPLY and ESPRIT Pacemakers interrogated using Orchestra and Orchestra Plus Programmers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Sorin Group Australia.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-01229-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01229-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    There could be overestimation of the residual longevity displayed by the programmer during a follow-up exam of patients implanted with a reply or esprit pacemakers. because of this incorrect information, the follow-up dates might not have been adjusted when nearing the elective replacement indicator (eri). when the device approaches the eri, this overestimation of the residual longevity could result in eri or end of life (eol) being reached between two follow-up visits. please note that when the devices are programmed at high energy outputs (e.G. high pulse amplitude and width) associated to a high percentage of paced events, longevity can be reduced. no permanent injury or death has occurred as a result of the reported events. in all reported events, pacing functions were maintained at follow-up time.
  • Action
    Sorin CRM is asking clinicians to implement the following patient management recommendations: - Consider checking the battery impedance of the last follow-up exam. In case the battery impedance is greater than or equal to 3.5k?, a follow-up visit must be scheduled within a maximum of 6 months from the last follow-up visit. -When pacemaker operation is checked by the simple application of a magnet, a magnet rate less than 95 min-1 should trigger a follow-up exam in the pacemaker centre. -As a general rule, a maximum of 6 month follow-up interval when the battery impedance becomes greater than or equal to 3.5 k?. This recommendation should also be followed subsequent to the installation of the new programmer software version. A new programmer software version (SmartView 2.40 version or higher) will be released to correct the time to ERI and its presentation through the color-coded gauge. Sorin representative will inform the users as soon as the software upgrade is available. For more details, please see http://tga.gov.au/safety/alerts-device-orchestra-devices-and-espirit-pacemakers-131129.htm .

Device

REPLY and ESPRIT Pacemakers interrogated using Orchestra and Orchestra Plus Programmers
  • Model / Serial
    REPLY and ESPRIT Pacemakers interrogated using Orchestra and Orchestra Plus ProgrammersREPLY DR dual chamber pacemakerCatalogue Number: ICV1099ARTG Number:152879REPLY SR single chamber pacemakerCatalogue Number: ICV1119ARTG Number: 158733ESPRIT DR dual chamber pacemakerCatalogue Number: ICV1114ARTG Number:163898ESPRIT SR single chamber pacemakerCatalogue Number: ICV1125ARTG Number:163899
  • Manufacturer
    Sorin Group Australia

Manufacturer

Sorin Group Australia