Events

Safety Alert for QuickSite® and QuickFlex® Left Ventricular CRT Leads [Models 1056T, 1058T, 1156T and 1158T]

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
    2012-04-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120413.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
    Field safety notice: st. jude medical quicksite® and quickflex® left ventricular crt leads [models 1056t, 1058t, 1156t and 1158t] medical device manufacturer, st. jude medical, initiated a field safety corrective action concerning the quicksite® and quickflex® left ventricular crt leads [models 1056t, 1058t, 1156t and 1158t]. according to the manufacturer, the affected devices are designed for use in combination with a compatible pulse generator to provide long-term stimulation and sensing of the left ventricle via the great cardiac vein or one of its tributaries. the manufacturer had found 39 confirmed cases of externalized conductor. it was estimated that 3-4% of quicksite® and quickflex® leads may exhibit the anomaly. there were no reports of death or serious injury associated with externalized conductor. according to the manufacturer, if externalization of the cable conductor were to occur, the etfe coating on the cables is designed to provide adequate dielectric strength for the lead to continue to function normally without the silicone covering. the system also provides for multiple alternative pacing configurations that can be programmed, if needed. although no electrical dysfunction attributable to these external conductors has been observed to date, in the case that all of these redundancies were to fail, the inability of the lv crt lead to pace could affect biventricular pacing and result in exacerbation of heart failure. the manufacturer recommended physicians to continue to monitor their patient’s implanted system at regularly scheduled intervals with attention paid to diagnostic information related to lv pacing performance, in particular lv lead impedance and capture thresholds. in addition, programming of alerts that monitor lead impedance changes outside of the nominal range and enabling the patient notifier should be considered. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

QuickSite® and QuickFlex® Left Ventricular CRT Leads [Models 1056T, 1058T, 1156T and 1158T]
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: St. Jude Medical QuickSite® and QuickFlex® Left Ventricular CRT Leads [Models 1056T, 1058T, 1156T and 1158T]
  • 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