Events

Safety Alert for Ellipse VR/DR Implantable Cardioverter Defibrillators

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by St. Jude Medical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-08-20
  • Event Date Posted
    2014-08-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140820a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: st. jude medical ellipse vr/dr implantable cardioverter defibrillators the australia therapeutic goods administration (tga) posted a medical device safety alert concerning ellipse vr/dr implantable cardioverter defibrillators (icds) manufactured by st. jude medical. the affected models are cd1277 (-36 and -36q), cd1377 (-36, -36q, -36c and -36qc), cd2277 (-36 and -36q) and cd2377 (-36, -36q, -36c and -36qc). icds with serial numbers beginning with “1” that are below 1132470, beginning with the number “7” that are below 7126267 and all serial numbers beginning with an “8” are affected. the manufacturer has received complaints that extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices. as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value. this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock. according to the manufacturer, there have been no reported cases of an ellipse device failing to deliver high voltage therapy to a patient when needed. the manufacturer is providing appropriate patient management recommendations to surgeons for managing patients who are implanted with the affected devices. furthermore, the manufacturer advises customers that the affected stock will be retrieved and replaced by new ellipse icds with the redesigned high voltage capacitor eliminating the source of capacitor damage at the front alignment hole. for details, please refer to tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00905-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 august 2014.

Device

Ellipse VR/DR Implantable Cardioverter Defibrillators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH