MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-29 for DUAL CHAMBER TEMPORARY PACEMAKER 5392 manufactured by Medtronic, Inc..
Report Number | 2182208-2019-02150 |
MDR Report Key | 9391936 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2019-11-29 |
Date of Report | 2019-11-29 |
Date of Event | 2019-10-30 |
Date Mfgr Received | 2019-11-22 |
Device Manufacturer Date | 2015-07-06 |
Date Added to Maude | 2019-11-29 |
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, INC. |
Manufacturer Street | 8200 CORAL SEA STREET NE |
Manufacturer City | MOUNDS VIEW MN 55112 |
Manufacturer Country | US |
Manufacturer Postal Code | 55112 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | DUAL CHAMBER TEMPORARY PACEMAKER |
Generic Name | PULSE-GENERATOR, PACEMAKER, EXTERNAL |
Product Code | DTE |
Date Received | 2019-11-29 |
Returned To Mfg | 2019-11-01 |
Model Number | 5392 |
Catalog Number | 5392 |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDTRONIC, INC. |
Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-29 |