Events

Safety Alert for CABLES-ELETRODOS SPRINT FIDELIS - MEDTRONIC. MODELS: 6930, 6931, 6948 and 6949.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medtronic Inc.; Medtronic Comercial 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
    886
  • Date
    2007-10-16
  • 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
    The Medtronic Ltda. Has already received a communication from Medtronic Ltda informing the product collection action in Brazil. #### Update (29/02/2008): Medtronic Ltda has already sent to Medtronic Inc (Minneapolis - USA) all Sprint Fidelis cables collected in Brazil. In total, 471 cables were collected and shipped. #### Update (05/08/2011): Medtronic is informing its customers by means of an alert message that, in the event of a fracture in a Fidelis stimulation conductor , the company recommends implanting a new high-voltage electrode cable, with or without withdrawal of the fractured Fidelis Electrode Cable. Implantation of a stimulation lead is no longer an option recommended by the company, while maintaining the use of Fidelis High Voltage Conductors after a fracture in a Fidelis stimulation conductor.
  • Reason
    The company medtronic is suspending the distribution of the electrode cables of the sprint fidelis line, used in implanted defibrillators. according to the company, there is a possibility of cable-electrode fracture after its implantation.
  • Action
    Immediately stop using the Sprint-Fidelis Model 6930, 6931, 6948, and 6949 electrode cables for further implantation of defibrillators. The company Medtronic Inc also reported that those patients who have implanted electrode cables (of the models above) should seek their doctors for guidance. Medtronic recommends the following actions as an integral part of routine patient monitoring: Reduce the risk of detection and inappropriate therapies (motivated by oversensing) by scheduling VF detection by adjusting the initial Number of Intervals to be Detected (NID) for nominal (18/24) or higher, as physician assessment and re-detection NID for nominal parameters (12/16). Turn ON Patient Alert ™ for RV Pacing, RV Defibrillation, and VCS defibrillation impedances. To optimize the efficacy of electrode impedance alert, the recommendation is as follows: 1) Review the electrode V pacing behavior curve to calculate the patient's usual chronic impedance value (the usual Fidelis electrode values ​​should be between 350-1000 ohms). 2) Maximum electrode impedance alert threshold for 1000 ohm RV stimulation in case the patient's normal chronic impedance is less than or equal to 700 ohms or 3) Maximum electrode impedance alert threshold for RV 1500 stimulation ohms, in case the patient's normal chronic impedance is greater than or equal to 700 ohms. 4) Maximum limit of the electrode impedance alert for RV and 100 ohm VCS defibrillation. It is estimated that the aforementioned patient treatment recommendations increase the likelihood that the lead wire fracture will be detected by the Patient Alert and reduce the possibility of administering inappropriate therapies. According to the review of the available data, a more frequent follow-up does not seem to bring an additional benefit.

Device

CABLES-ELETRODOS SPRINT FIDELIS - MEDTRONIC. MODELS: 6930, 6931, 6948 and 6949.

Manufacturer

Medtronic Inc.; Medtronic Comercial Ltda
  • Source
    ANVSANVISA