International safety notice
Alert 2706 (Technosurveillance) - St. Jude Medical Brasil LTDA - St. Jude Medical Infinity DBS 8-Channel Electrode and Extension System - Possibility of the product containing a pole that does not comply with the specifications.
Brazil / Anvisa · BRA · Oct 24, 2018
Key facts
| Title | Alert 2706 (Technosurveillance) - St. Jude Medical Brasil LTDA - St. Jude Medical Infinity DBS 8-Channel Electrode and Extension System - Possibility of the product containing a pole that does not comply with the specifications. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: St. Jude Medical Infinity DBS 8-Channel Electrode and Extension System Technical Name: Cable/Electrode For Deep Brain Electrical Stimulation System ANVISA registration number: 10332340412 Risk Class: IV Affected model: 6170; Affected serial numbers: See attachment List of lots at risk |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ST JUDE MEDICAL BRASIL LTDA CNPJ 00986846000142 RUA ITAPEVA 538 5º AO 8º ANDARES SÃO PAULO SÃO PAULO TEL 11 5080 5454 EMAIL ROBERTAPETROCINOABBOTTCOM FABRICANTE DO PRODUTO ST JUDE MEDICAL 6901 PRESTON ROAD PLANO TX 75024 USA ESTADOS UNIDOS |
| Models | 10332340412 |
| Date | Oct 24, 2018 |
| 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