Events

Safety Alert for pacemakers REPLY (D, DR, VDR and SR models), ESPRIT (D, DR, S and SR models) and FACIL (DR model)

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Sorin CRM S.R.L.

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
    2013-11-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131120b.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
    Press release
  • Reason
    Safety alert on three sorin pacemakers the department of health (dh) today (november 20) drew public attention to a safety notice issued by a local medical device supplier, innotronik hong kong limited, on the overestimation of the residual longevity displayed by the programmer for three models of pacemakers manufactured by sorin crm s.R.L. the affected devices are reply (d, dr, vdr and sr models), esprit (d, dr, s and sr models) and facil (dr model). the manufacturer received several reports in which the devices' elective replacement indicator indicating the time for elective replacement had been reached while the time to elective replacement indicated by the programmer during previous follow-up was at a later date. "when the device approaches the time for elective replacement, such an overestimation of the residual longevity could lead to time for elective replacement or even end of life (eol) being reached between two follow-up consultations. yet, as the first implantation of the pacemakers concerned in hong kong was in 2010 and the overall longevity is not affected, the affected devices are still well ahead of the time for elective replacement and eol," a spokesman for the dh explained. sorin said that no permanent injuries or deaths have occurred in connection with the issue. a new programmer version will be released to correct the problem. according to innotronik, some 400 patients from both public and private hospitals were implanted with the affected devices in hong kong and the company has informed the hospital authority and the relevant physicians of the affected private hospitals. "the dh has not received reports of any local adverse incidents in connection with the use of the affected devices so far," the spokesman remarked. "patients with the affected devices who are feeling unwell or in doubt should promptly consult their health-care professionals," the spokesman advised. the dh has informed relevant stakeholders about the alert and shall continue to liaise with innotronik on the follow-up actions. ends.

Device

pacemakers REPLY (D, DR, VDR and SR models), ESPRIT (D, DR, S and SR models) and FACIL (DR model)
  • Model / Serial
  • Product Description
    Press release: Safety alert on three Sorin pacemakers
  • Manufacturer
    Sorin CRM S.R.L

Manufacturer

Sorin CRM S.R.L