Events

Safety Alert Or Field Safety Notices for SQ-RX® pulse generator, model 1010

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 Cameron Health.

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/2011/067
  • Date
    2011-06-13
  • 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-sq-rx-pulse-generator-model-1010-subcutaneous-implantable-cardioverter-defibrillator-s-icd-battery-might-die-early
  • 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 S-ICD being unable to deliver shock for therapy after elective replacement indicator (ERI) audible warning.The ERI may occur earlier than expected and the end of life (EOL) indicator may occur before the nominal 3 months.The manufacturer has identified two populations of devices in the UK that are at higher risk of premature battery depletion.Population 1: 33% risk of premature battery failure over five years – three devices in the UK.Population 2: 3.3% risk of premature battery failure over five years – 81 devices in the UK.The MHRA has received one confirmed report of premature battery failure associated with this issue, occurring after 9 months.Bench tests performed by the manufacturer showed that the affected devices may deplete over a period of between one month and 2 years.Cameron Health issued a Field Safety Notice on 1 June 2011 (130Kb) to highlight this risk to physicians.Please note that the FSN contains worldwide number of affected devices.
  • Reason
    (cameron health) risk of premature depletion of battery before the 3 nominal months. (mda/2011/067).
  • Action
    Identify all patients with affected S-ICD (see appendix) and schedule immediate follow-up to: familiarise patients with audible alert on the S-ICD (using magnet) remind patients of the importance of contacting their follow-up clinic as soon as possible in the event of symptoms or the onset of any audible patient alarm. For patients identified in population 1, consider an immediate box change only for high risk patients, such that they are likely to require multiple shocks within the space of a few days. For all patients in population 2, arrange follow-up at three-month intervals, to review if the battery voltage is dropping at a faster rate than predicted.

Device

SQ-RX® pulse generator, model 1010
  • Model / Serial
  • Product Description
    Subcutaneous implantable cardioverter defibrillator (S-ICD): SQ-RX® pulse generator, model 1010.Manufactured by Cameron Health.
  • Manufacturer
    Cameron Health

Manufacturer

Cameron Health
  • Manufacturer Address
    Stephen O’Connor Cameron Health 4 The Green Bromham Bedfordshire MK43 8JR Tel: 07984 590 639 Fax: 01223 280 382Email: soconnor@cameronhealth.com
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    MHRA