Events

Alerte De Sécurité sur 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).

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Boston Scientific do Brasil Ltda.; Boston Scientific..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1006
  • Date
    2010-02-23
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “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