Events

Safety Alert for Implantable Cardioversor Defibrillator TELIGEN 100 (Anvisa Record: 10341350535; affected models: F102; E102) ;. . Cardioversor Implantable Defibrillator TELIGEN 100 Dual Camera (Anvisa Record: 10341350534; affected models: F110; F111; E110; E111); and. . Implantable Resynchronizing Defibrillator COGNIS 100 (Anvisa Record: 10341350536; affected models: P106; P107; P108; N106; N107; N108; N118; N119).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific do Brasil Ltda.; Boston Scientific..

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
    1006
  • Date
    2010-02-23
  • 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 manufacturer of the product (Boston Scientific) has concluded, after analysis, that the link between the head and the housing of the aforementioned equipment can be weakened by significant forces associated with the sub-pectoral implant procedure or when such a device already implanted, is pressed against a rib - which occurs during contraction of the patient's pectoral muscle. A weakened head link may alter electrode impedance and produce noise, which may inhibit pacemaker stimulation or initiate inadequate therapy for tachycardia. In addition, additional mechanical wear applied on a weakened link may eventually lead to fracture of the connecting wires of the head, resulting in loss of therapy. The clinical implications are as follows: (1) Significant changes in electrode impedance measurement; (2) Noise, in real time or in accumulated electrograms; (3) Intermittent pacemaker inhibition; (4) Anti-tachycardia pacing, or inappropriate shock therapy; (5) Pacing pacing output block; (6) Blockade of anti-tachycardia and shock therapy stimulation.
  • Reason
    When the defibrillator is implanted sub-pectorally, there is a possibility of weakening the link between the head and the chest of the device.
  • Action
    Avoid sub-pectoral implantation of the defibrillators mentioned in this alert.

Device

Implantable Cardioversor Defibrillator TELIGEN 100 (Anvisa Record: 10341350535; affected models: ...

Manufacturer

Boston Scientific do Brasil Ltda.; Boston Scientific.
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    ANVSANVISA