Events

Safety Alert Or Field Safety Notices for Sprint Fidelis implantable cardioverter defibrillator (ICD) lead

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 Medtronic.

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 Number
    MDA/2011/051
  • Date
    2011-05-19
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-sprint-fidelis-implantable-cardioverter-defibrillator-icd-lead-risk-of-inappropriate-shocks
  • 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
    Risk of inappropriate shocks and loss of therapy.Increased risk that the high voltage conductor will fracture if the pace-sense conductor has previously fractured in the same lead.In March 2009 Medtronic issued a Field Safety Notice (FSN) (42Kb) advising clinicians that one option for dealing with this problem was to implant a new pace-sense lead while maintaining the use of the high voltage conductor.However, Medtronic estimates that the survival for the Sprint Fidelis high voltage conductor is 77.7% at 21 months if a pace-sense conductor fracture has previously occurred. Therefore, Medtronic no longer recommends this course of action and has issued another FSN (April 2011) (586Kb). All other patient management recommendations in the March 2009 FSN remain unchanged.
  • Reason
    (medtronic) use of sprint fidelis icd lead could create risk of inappropriate shocks and loss of therapy with model numbers 6930, 6931, 6948 and 6949. (mda/2011/051).
  • Action
    Identify patients where:the pace-sense conductor has fractured, a new pace-sense lead has been inserted and the high voltage conductor remains in use.For these patients, consider the need to implant a new high voltage conductor at elective device change, taking into account the age and clinical circumstances of the patient.If these patients are at high risk of sudden cardiac death in the event of high voltage conductor failure, then consider elective lead replacement before device change.Where a new conductor fracture occurs, implant a new high voltage lead. Where a lead is functioning normally, continue with existing patient management recommendations and use of Medtronic Lead Integrity Alert (LIA). This should be done taking into account the recent update in long term lead survival data presented in the FSN (April 2011) (586Kb).

Device

Sprint Fidelis implantable cardioverter defibrillator (ICD) lead
  • Model / Serial
  • Product Description
    Implantable cardioverter defibrillator (ICD) lead.Sprint Fidelis, model numbers: 6930, 6931, 6948 and 6949.Manufactured by Medtronic.
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Address
    Mrs Lezlie Bridge Medtronic Limited Building 9 Croxley Green Business Park Hatters Lane Watford Hertfordshire WD18 8WW Tel: 01923 212 213 Fax: 01923 225 273Email: lezlie.j.bridge@medtronic.com
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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
    MHRA