MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-30 for ASTRA XT DR MRI SURESCAN X2DR01 manufactured by Medtronic Europe Sarl.
Report Number | 9614453-2019-04001 |
MDR Report Key | 9392238 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-11-30 |
Date of Report | 2019-12-02 |
Date of Event | 2019-11-23 |
Date Mfgr Received | 2019-11-29 |
Device Manufacturer Date | 2019-10-02 |
Date Added to Maude | 2019-11-30 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | PAULA BIXBY |
Manufacturer Street | 8200 CORAL SEA ST NE |
Manufacturer City | MOUNDS VIEW MN 55112 |
Manufacturer Country | US |
Manufacturer Postal | 55112 |
Manufacturer Phone | 7635055378 |
Manufacturer G1 | MEDTRONIC EUROPE SARL |
Manufacturer Street | ROUTE DU MOLLIAU 31 CASE POSTALE |
Manufacturer City | TOLOCHENAZ VAUD 1131 |
Manufacturer Country | CH |
Manufacturer Postal Code | 1131 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ASTRA XT DR MRI SURESCAN |
Generic Name | PULSE GENERATOR, PERMANENT, IMPLANTABLE |
Product Code | NVZ |
Date Received | 2019-11-30 |
Model Number | X2DR01 |
Catalog Number | X2DR01 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDTRONIC EUROPE SARL |
Manufacturer Address | ROUTE DU MOLLIAU 31 CASE POSTALE TOLOCHENAZ VAUD 1131 CH 1131 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-11-30 |