Events

Safety Alert for Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan Pacemakers

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtronic.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2018-06-28
  • Event Date Posted
    2018-06-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180628a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: percepta crt-p mri surescan and percepta quad crt-p mri surescan pacemakers medical device manufacturer, medtronic, has issued a medical device safety alert concerning its percepta crt-p mri surescan and percepta quad crt-p mri surescan pacemakers [model: w1tr04 and w4tr04]. the manufacturer has identified the issue of potential for a device reset to occur in percepta crt-p mri surescan and percepta quad crt-p mri surescan due to a timing interaction between the effectivcrt diagnostic and the ventricular safety pacing feature (vsp). when an ap-vs interval measures 100-109ms during a short, nightly device check, a single reset is generated. the reset produces a non-programmable, wireless carealert, but does not alter device therapy. if the device experiences more than five resets due to the timing sequence between in-clinic device interrogations, a full reset (sometimes referred to as a power on reset) will occur. by design, a full reset automatically reverts device operation to rv-only pacing at vvi/65 until the next programmer session is conducted – at which time the full reset condition can be cleared, and the device can be reprogrammed to its prior settings. according to the manufacturer, through 14 jun 2018, it has confirmed 105 single reset events and 14 full reset events, with no patient deaths or complications. if the patient management guidance is followed, no additional resets due to the timing interaction will occur. a software update, application sw040 version 8.1, is available for installation onto all carelink model 2090 and encore programmers to eliminate the issue. once installed on a programmer, an in-clinic device interrogation will update the patient's device automatically to prevent the timing interaction from generating a reset. no changes to programmed device functionality will occur as a result of the device update. in consultation with the independent physician quality panel, the manufacturer recommends the following actions: contact the local representative and schedule installation of the updated percepta crt-p application software (sw040 version 8.1) onto medtronic 2090 and encore programmers; for a patient whose percepta crt-p device has experienced a reset alert or observation, consider scheduling an in-clinic device interrogation as soon as possible for the patient's device to receive the automatic update; for a patient whose percepta crt-p device has not experienced a reset alert or observation, at their next scheduled in-clinic device interrogation, the patient's device will receive the automatic update. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 june 2018.

Device

Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan Pacemakers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan Pacemakers
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH