Alerta De Seguridad para 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).

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.

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.