Events

Safety Alert for TACHYARRITMIA RIATA ELECTRODE (1580/1581); RADIANT TRANSCENDANT TACHYARRHYTHMIA ELECTRODE (1570/1571); CABLE ELECTRODE OF TRANSIENTAL TRAQUIARRITMIA RIATA (7000, 7001 and 7002); CABO ELETRODO DE TACHIARRITMIA TRANSVENOSO RIATA (1940/1941); CABLE ELETRODO DE TACHIARRITMIA TRANSVENOSO RIATA 1942 (1942); CABLE ELECTRODE OF TACHYARRHYTHMIA TRANSVENOSO RIATA ST (7040/7041); and CABLE ELETRODE OF TRANSVENIOUS TACHYARRHYTHMIA RIATA ST 7042 (ST 7042). Registers in Anvisa: 10332340094 (discontinued on 02/25/2008), 10332340106 (12/29/2008), 10332340172, 10332340188, 10332340189, 10332340191 and 10332340201.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by St. Jude Medical Brasil Ltda..

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
  • Event ID
    1047
  • Date
    2011-02-05
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    According to the holder of the product registration in Brazil (St. Jude Medical Brazil Ltda.), The silicone coating, which represents the most commonly used defibrillation electrode insulation material in the industry in the last 20 years, has been found to be vulnerable to abrasion. Due to this fact, the company began to discontinue the commercialization of Riata and Riata ST electrodes. For more information on the problem and the evaluations made by the manufacturer of the product, consult http://portal.anvisa.gov.br/wps/wcm/connect/56bdfd0045b3b5bba661f744bdb3a983/Carta_Medicos_St+Jude.pdf?MOD=AJPERES. Anvisa's Technovigilance Unit is monitoring this case.
  • Reason
    Electrode cables may present loss of insulation over time at a higher rate than normal.
  • Action
    The company is discontinuing the commercialization of all models of silicone electrodes Riata and Riata ST. With regard to health professionals who are accompanying patients implanted with Riata and Riata ST silicone electrodes, it is recommended: (1) To continue to monitor the system implanted in their patient at regularly scheduled intervals, paying particular attention to diagnostic information related to the defibrillation electrodes. The frequency of personal and remote monitoring is a follow-up period of 3-6 months for CDI / CRT-D devices; (2) Review electrode measurements, including pace and impedance of high-voltage electrodes, according to their standard follow-up procedures, in particular by looking for significant changes from the last follow-up visits of the patient; (3) If electrode failure is suspected, consider using provocative tests - such as arm and shoulder movements and deep breathing during observation of surface ECG and intracardiac electrocardiograms with the programmer, which tests may reveal a problem (if any). Also consider additional evaluation of the system (eg x-ray or fluoroscopy); (4) Consider remote monitoring and advise their patients on the importance of contacting them if they experience any adverse events; (5) Prophylactic electrode explant is not recommended.

Device

TACHYARRITMIA RIATA ELECTRODE (1580/1581); RADIANT TRANSCENDANT TACHYARRHYTHMIA ELECTRODE (1570/1...

Manufacturer

St. Jude Medical Brasil Ltda.
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA