International safety notice
Alert 2817 (Technosurveillance) - Medtronic - Generators for MRI Spinal Cord Stimulation, Medtronic Programmable Neurostimulator and Activa Programmable Neurostimulator - Information on updating the FA735 field action.
Brazil / Anvisa · BRA · Mar 14, 2019
Key facts
| Title | Alert 2817 (Technosurveillance) - Medtronic - Generators for MRI Spinal Cord Stimulation, Medtronic Programmable Neurostimulator and Activa Programmable Neurostimulator - Information on updating the FA735 field action. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Generators for RM Spinal Cord Stimulation (10339190453); Technical Name: Implantable Pulse Generator for Neurostimulation (10339190453); ANVISA registration number: 10339190453; Risk Class: IV. Affected model: N/A. Affected serial numbers: See attachment "List of serial numbers at risk". |
| 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 NEUROMODULATION 800 53RD AVE NE ESTADOS UNIDOS |
| Models | 10339190453, 10339190338, 10339190310 |
| Date | Mar 14, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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