International safety notice
Alert 2601 (Technovigilance) - Medtronic Comercial Ltda - Entrust Implantable Cardioverter Defibrillator Possibility of loss of high voltage therapy and antitachycardia stimulation.
Brazil / Anvisa · BRA · Jul 9, 2018
Key facts
| Title | Alert 2601 (Technovigilance) - Medtronic Comercial Ltda - Entrust Implantable Cardioverter Defibrillator Possibility of loss of high voltage therapy and antitachycardia stimulation. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Entrust Implantable Cardioverter Defibrillator Technical Name: Implantable Cardioverter and Defibrillator ANVISA registration number: 10339190257 Risk Class: III Affected model: D153ATG / D153DRG / D153VRC / D154ATG / D154DRG / D154VRC Affected serial numbers: See List of Affected Lots. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MEDTRONIC COMERCIAL LTDA CNPJ 01772798000152 AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR CEP 04675010 SÃO PAULO SP TEL 11 21829200 EMAIL TECNOVIGILANCIACOVIDIENCOMNATALIAJMAIAMEDTRONICCOM FABRICANTE DO PRODUTO MEDTRONIC EUROPE SÀRL ROUTE DU MOLLIAU 31 PO BOX CH1131 TOLOCHENAZ SUÍÇA |
| Models | 10339190257, D154DRG, D154VRC, D153DRG, D154ATG, D153ATG, D153VRC |
| Date | Jul 9, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1