MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-27 for VIVA? QUAD XT CRT-D DTBA1Q1 manufactured by Medtronic Puerto Rico Operations Co..
Report Number | 3004209178-2019-22762 |
MDR Report Key | 9384581 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2019-11-27 |
Date of Report | 2019-11-27 |
Date of Event | 2019-10-31 |
Date Mfgr Received | 2019-10-31 |
Device Manufacturer Date | 2016-12-30 |
Date Added to Maude | 2019-11-27 |
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 PUERTO RICO OPERATIONS CO. |
Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
Manufacturer City | JUNCOS PR 00777 |
Manufacturer Country | US |
Manufacturer Postal Code | 00777 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VIVA? QUAD XT CRT-D |
Generic Name | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO |
Product Code | NIK |
Date Received | 2019-11-27 |
Model Number | DTBA1Q1 |
Catalog Number | DTBA1Q1 |
Device Expiration Date | 2018-06-28 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-11-27 |