International safety notice
Alert 2810 (Technovigilance) - Medtronic Comercial Ltda - Multipolar Pulmonary Vein Ablation Catheter - PVAC Gold - Update of instructions for use related to reducing the risk of damage to the phrenic nerve.
Brazil / Anvisa · BRA · Mar 11, 2019
Key facts
| Title | Alert 2810 (Technovigilance) - Medtronic Comercial Ltda - Multipolar Pulmonary Vein Ablation Catheter - PVAC Gold - Update of instructions for use related to reducing the risk of damage to the phrenic nerve. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Multipolar Pulmonary Vein Ablation Catheter - PVAC Gold Technical Name: Multipolar Pulmonary Vein Ablation Catheter ANVISA registration number: 10339190437 Risk Class: III Affected model: PVAC Gold (990078) Affected serial numbers: All product 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 TECNOVIGILANCIACOVIDIENCOM FABIOLACAPPELLARIMEDTRONICCOM FABRICANTE DO PRODUTO MEDTRONIC INC 710 MEDTRONIC PARKWAY MINNEAPOLIS MN 55432 ESTADOS UNIDOS |
| Models | 10339190437, 990078 |
| Date | Mar 11, 2019 |
| 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