Events

Safety Alert for Devices for Bradyarrhythmia Therapy, Antiachyarrhythmia

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Biotronik Se & Co Kg || Greatbatch 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
  • Event ID
    R1708-351
  • Event Number
    2015DM-0003023-R1
  • Date
    2017-10-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=68
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data

Device

Devices for Bradyarrhythmia Therapy, Antiachyarrhythmia
  • Model / Serial
    394982, 383588, 393026, 375523, 392289, 392291, 370701, 370702,
  • Product Description
    Implantable endocardial electrodes include accessories: SETROX S 45, SETROX S 53, SETROX S 60, SAFIO S 45, SAFIO S 53, SAFIO S60. Implantable endocardial electrodes includes accessories: SIELLO S45, SIELLO S 53, SIELLO S 60, SIELLO T 53, SIELLO T 60, SIELLOJT 45, SIELLO JT 53, SOLIA S 45, SOLIA S 53, SOLIA S 60, SOLIA T53, SOLIA T 60. implantable cardioid-defibrillator electrodes include accessories: PROTEGO S 65, PROTEGO S 75, PROTEGO SD65 / 16 , PROTEGO SD 65/18, PROTEGO SD 75/18, PROTEGOPROMRI S 65, PROTEGO PROMRI S 75, PROTEGO PROMRI SD65 / 16, PROTEGO PROMRI SD 65/18, PROTEGO PROMRI SD75 / 18.electrodes implantable for cardio-defibrillators includesaccessories: LINOX SMART S 65, LINOX SMART S 75 LINOX, SMARTSD 60/16, LINOX SMART SD 65/18, LINOX SMART SD 75/18, LINOXSMART S DX 65/15, LINOX SMART S DX 65/17, LINOX SMARTPROMRI S 65, LINOX SMART PROMRI S 75, LINOX SMART PROMRISD 65/16, LINOX SMART PROMRI SD 65/18, LINOX SMART PROMRISD 75/18, LINOX SMART PROMRI S DX 65/15, LINOX SMARTPRO MRI S DX 65/17. Indications for use: electrodes compatible with MRI technology, safe in their use MRI under certain conditions, therefore conditional MRI is indicated.
  • Manufacturer
    Biotronik Se & Co Kg || Greatbatch Medical

Manufacturer

Biotronik Se & Co Kg || Greatbatch Medical
  • Source
    NIDFSINVIMA