Brand Name | RESOLUTE ONYX |
Type of Device | CORONARY DRUG-ELUTING STENT |
Manufacturer (Section D) |
MEDTRONIC, INC. |
710 medtronic pkwy. |
minneapolis MN 55432 |
|
MDR Report Key | 9309401 |
MDR Text Key | 165976743 |
Report Number | 9309401 |
Device Sequence Number | 1 |
Product Code |
NIQ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/30/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/12/2019 |
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | RONYX25038 |
Device Lot Number | 0009753864 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/30/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/12/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 25915 DA |
|
|