International safety notice
Alert 2899 (Technosurveillance) Medtronic Dual Chamber MRI Conditional Pacemaker with Surescan Technology - Pacemaker with Surescan Cardiac Resynchronization Therapy Performance Note on failure mode.
Brazil / Anvisa · BRA · Jun 6, 2019
Key facts
| Title | Alert 2899 (Technosurveillance) Medtronic Dual Chamber MRI Conditional Pacemaker with Surescan Technology - Pacemaker with Surescan Cardiac Resynchronization Therapy Performance Note on failure mode. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Dual Chamber MRI Conditional Pacemaker with Surescan Technology (10339190812); Technical Name: Dual Chamber Implantable Cardiac Pacemaker, with Rate Response (10339190812); ANVISA registration number: 10339190812; Risk Class: IV Affected model: W1DR01, W2DR01, W3DR01, W1SR01, W2SR01, W3SR01 Affected serial numbers: All lots are affected. |
| 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 TECNOVIGILANCIACOVIDIENCOM FABIOLACAPPELLARIMEDTRONICCOM FABRICANTE DO PRODUTO MEDTRONIC PUERTO RICO OPERATION CO JUNCOS ROAD 31 KM 24 HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS 00777 PUERTO RICO |
| Models | W2SR01, W1SR01, W3SR01, W2DR01, 10339190812, W3DR01, W1DR01, 10339190708 |
| Date | Jun 6, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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