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 2019-11-15 for AMPERE? RF ABLATION GENERATOR H700489 manufactured by St. Jude Medical, Inc..
Report Number | 2184149-2019-00219 |
MDR Report Key | 9328173 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-11-15 |
Date of Report | 2019-11-25 |
Date of Event | 2019-03-05 |
Date Mfgr Received | 2019-11-18 |
Device Manufacturer Date | 2014-08-28 |
Date Added to Maude | 2019-11-15 |
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 | STEPHANIE O' SULLIVAN |
Manufacturer Street | 5050 NATHAN LANE NORTH |
Manufacturer City | PLYMOUTH MN 55442 |
Manufacturer Country | US |
Manufacturer Postal | 55442 |
Manufacturer Phone | 6517565400 |
Manufacturer G1 | ST. JUDE MEDICAL, INC. (AF-ST. PAUL) |
Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
Manufacturer City | ST. PAUL MN 55117 |
Manufacturer Country | US |
Manufacturer Postal Code | 55117 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AMPERE? RF ABLATION GENERATOR |
Generic Name | GENERATOR, LESION, RADIOFREQUENCY |
Product Code | GXD |
Date Received | 2019-11-15 |
Model Number | H700489 |
Lot Number | 5365479 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ST. JUDE MEDICAL, INC. |
Manufacturer Address | ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-11-15 |