Brand Name | EUPHORA |
Type of Device | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
Manufacturer (Section D) |
MEDTRONIC, INC. |
3576 unocal place |
santa rosa CA 95403 |
|
MDR Report Key | 6689163 |
MDR Text Key | 79145858 |
Report Number | 6689163 |
Device Sequence Number | 1 |
Product Code |
LOX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
06/21/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/06/2017 |
Is this a Product Problem Report? |
Yes
|
Device Operator |
Unknown
|
Device Catalogue Number | EUP2515X |
Device Lot Number | 212621115 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 06/21/2017 |
Event Location |
Hospital
|
Date Report to Manufacturer | 06/21/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Treatment | NOT KNOWN.; UNKNOWN. |
Patient Age | 73 YR |
|
|