Events

Safety Alert Or Field Safety Notices for Riata and Riata ST – all silicone coated models

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by St Jude Medical.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2012/061
  • Event Number
    CON184434
  • Date
    2012-09-10
  • Event Date Posted
    2012-09-10
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON184434?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Risk of inappropriate shock or therapy failure due to wear of lead insulation after implantation. these patient follow-up recommendations replace those given previously in mda/2010/095 and mda/2011/112. in december 2011, the mhra issued a medical device alert (mda/2011/112) recommending enhanced patient follow-up for all patients implanted with riata and riata st lead models. at that time the frequency of follow-up was stratified according to lead model. current evidence suggests that the difference in prevalence of externalised cables between 8fr and 7fr lead models is decreasing. st jude medical has recently issued a field safety notice (dated 13 july 2012) detailing phase i of a riata lead evaluation study to investigate the prevalence of externalised cables using fluoroscopy. the clinical significance of externalised cables will not, however, be evident until phase ii of the study is completed; this is unlikely to be before the end of 2013. for this reason this medical device alert is focusing on detection of early signs of functional lead failure, as these lead models continue to fail at a higher rate.
  • Action
    Continue to follow up all patients implanted with Riata or Riata ST ICD lead models to identify any changes in lead performance, according to your own standard procedures (see further advice below). Undertake this: at three-month intervals (in clinic or via remote monitoring) to - monitor for HV lead noise using an unused EGM channel turn on RV AutoCapture™ (or equivalent) pacing to monitor pacing thresholds  and at six-month intervals (in clinic) to - ensure high voltage lead integrity (HVLI)  testing is performed. At box change, if a decision is made to continue to use the lead, ensure that the replacement device has remote/advanced monitoring capabilities. Consider the need for further examination e.g. by ECG or fluoroscopy*, if a lead failure is suspected. If a lead failure is confirmed, the risks and benefits of lead replacement options should be evaluated on a case-by-case basis in discussion with the patient. Note: Prophylactic lead explantation is not recommended, other than in exceptional clinical circumstances. * In all cases, the benefit of fluoroscopic screening should be weighed against the risks from radiation exposure on an individual patient basis, in line with the requirements of The Ionising Radiation (Medical Exposure) Regulations 2000. Further advice Where appropriate for patients, follow-up should continue to include: > provocative testing (e.g. shoulder/arm movements and deep respiration), which may help reveal an   intermittent problem > increasing the detection time of the VT zone to reduce the risk of oversensing and inappropriate shocks > ensuring the SVT discriminators are on, where applicable > ensuring that the lead impedance alarms are programmed on. Remind patients of the importance of contacting their follow-up clinic as soon as possible in the event of therapy delivery and/or the onset of any patient alert. Report all lead adverse incidents to the MHRA and to St Jude Medical.

Device

Riata and Riata ST – all silicone coated models
  • Model / Serial
  • Product Description
    Implantable cardioverter defibrillator (ICD) leads. Riata and Riata ST – all silicone coated models.
  • 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
    MHRA