International safety notice
Technical Name: IMPLANTABLE PULSE GENERATOR FOR NEUROStimulation
Brazil / Anvisa · BRA · May 10, 2016
Key facts
| Title | Technical Name: IMPLANTABLE PULSE GENERATOR FOR NEUROStimulation |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: MEDTRONIC PROGRAMMABLE NEUROSTIMULATOR (MODEL 37714) and RM Spinal Cord Stimulation Generators (MODEL 97714)// ANVISA registration number: 10339190310 and 10339190453 // Technical Name: IMPLANTABLE PULSE GENERATOR FOR NEUROSTIMULATION // Risk class: IV Maximum Risk // Affected models: MODELS 37714 (Registration 10339190310) and 97714 (Registration 10339190453)// Affected serial numbers: List in Annex |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO NOME MEDTRONIC COMERCIAL LTDA CNPJ 01772798000152 ENDEREÇO AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR 04675010 MUNICÍPIO SÃO PAULO UF SP TELEFONE DE CONTATO 11 21829200 FABRICANTE 1 MODELO 37714 NOME COMERCIAL DOS PRODUTO S NEUROESTIMULADOR PROGRAMÁVEL MEDTRONIC REGISTRO ANVISA 10339190310 FABRICANTES FÍSICOS MEDTRONIC PUERTO RICO OPERATIONS CO MEDREL PORTO RICO ENDEREÇO ROAD31 KM 24 HM 4 PR 007777 JUNCOS PORTO RICO MEDTRONIC NEUROMODULATION ESTADO UNIDOS ENDEREÇO 800 53RD AVENUE NE MINNEAPOLIS MN 55421 ESTADOS UNIDOS FABRICANTE LEGAL MEDTRONIC INC ENDEREÇO 710 MEDTRONIC PARKWAY MINNEAPOLIS MN 55432 ESTADO UNIDOS 2 MODELO 97714 NOME COMERCIAL DOS PRODUTO S GERADORES PARA ESTIMULAÇÃO DA MEDULA ESPINHAL RM REGISTRO ANVISA 10339190453 FABRICANTE MEDTRONIC INC ENDEREÇO 710 MEDTRONIC PARKWAY MINNEAPOLIS MN 55432 ESTADOS UNIDOS |
| Models | 97714, 10339190310, 37714, 10339190453 |
| Date | May 10, 2016 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 100–999 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