Events

Safety Alert for micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580

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

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
    2012-07-06
  • Event Date Posted
    2012-07-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120706.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: pace medical micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580 it has come to our attention that medical device manufacturer, pace medical, inc. has initiated a field safety corrective action concerning micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580. the manufacturer has had isolated reports of intermittent sensing issues with the affected product. under some circumstances, the affected device would fail to resume nominal sense operation once the programmed rate was lowered or became lower than the patients intrinsic rate. this was determined to be associated with depolarization of the regions surrounding the patient leads. with higher lead impedances the region surrounding the patient lead would take longer than expected to depolarize. this resulted in an extended offset period, which interfered with the device’s differential sense input amplifier. decreasing the device’s input impedance to 10k solved the depolarization effect allowing nominal sense operation with maximal rates and programmed outputs. a simple hardware change eliminates the potential for this occurrence. the manufacturer advised users that: they should return the affected product for complimentary upgrade. they may use the device while scheduling product return; however it is recommended that patients are monitored while the device is in use and that the device is not used with patients with “heart wires” until the modification has been made to the device. if you are in possession of the product, please contact your supplier for necessary actions. posted on 6 july 2012.

Device

micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Pace Medical MICRO-PACE™ dual-chamber temporary cardiac pacemaker, REF 4580
  • Manufacturer
    Pace Medical

Manufacturer

Pace Medical