Events

Safety Alert Or Field Safety Notices for Guidant VENTAK PRIZM® 2 DR

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 manufacturer #17429.

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/2005/037
  • Event Number
    CON1004068
  • Date
    2005-06-27
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON1004068
  • 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
    Potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage shock. following reports of malfunction from clinicians outside the uk, guidant reviewed the design and manufacturing processes for the ventak prizm® 2 dr icd. the company identified the potential for loss of therapy in all units manufactured on or before 16 april 2002, when corrective measures were implemented. on delivery of defibrillation therapy, the high voltage pulse may discharge (or arc) between the high voltage defibrillation output wire and a header component. the resulting discharge current may damage the icd electronics and cause any of the following: loss of: arrhythmia detection / therapy delivery bradycardia pacing output telemetry/ programming/ interrogation a red warning screen indicating malfunction a yellow warning screen indicating 'out of range' shocking impedance.
  • Action
    See action points on page 3. Ensure that follow-up intervals are no greater than three months; consider immediate review of all patients whose last follow-up was more than three months ago. Replace all devices in which high voltage therapy has been compromised. Remind patients to contact their follow-up centre immediately, if they hear audible bleeping from their device, experience shock therapy and/or arrhythmias/resumption of symptoms which remain uncorrected by the device. Report all instances of device failure to MHRA and Guidant Report explants to the National Pacing and ICD database (see contacts). ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS) Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines. Further information about SABS can be found at: www.info.doh.gov.uk/sar/cmopatie.nsf

Device

Guidant VENTAK PRIZM® 2 DR
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Guidant VENTAK PRIZM® 2 DR implantable cardioverter defibrillator (ICD) model No 1861 - see Appendix for full list of affected serial numbers.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429