Events

Recall of VALITUDE CRT-P

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Boston Scientific Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01509-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-12-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01509-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Boston scientific has received reports of intermittent oversensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). mv sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. this mv behavior may occur with any manufacturer’s pacing lead system, but boston scientific has determined it to be more likely for affected boston scientific pacemakers using medtronic or abbott/st. jude (abbott) leads implanted in either the right atrium (ra) or right ventricle (rv).
  • Action
    A software upgrade is being developed for distribution in early 2018. Until this is available to automatically resolve MV sensor signal oversensing, Boston Scientific recommends managing the risk for patients implanted with affected systems as follows: ·Subject to the the guidance supplied to customers, turn the MV sensor to “OFF” ·If transient, abrupt changes or any out-of-range RA/RV pacing impedance measurements are observed, contact Boston Scientific Technical Services to explore all non-invasive programming options prior to surgical intervention ·For patients with the MV sensor enabled, periodically re-assess for pacemaker dependence Doctors are encouraged to ·Enroll and follow patients using the LATITUDE NXT Remote Patient Management System ·Provide the supplied patient letter to all patients who are implanted with an affected device, and to patients who consent to having the device implanted before the software fix is available

Device

VALITUDE CRT-P
  • Model / Serial
    VALITUDE CRT-P Model U128ARTG 279333VISIONIST CRT-P Models U225, U226, U228ARTG 279330, 279331, 279332ACCOLADE PacemakersModels L310, L311, L331ARTG 280319, 280315, 280316PROPONENTpacemakers Models L210, L211, L231ARTG 280320, 280317, 280318
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • 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
    DHTGA