Brand Name | ORSIRO 3.0/30 |
Type of Device | CORONARY DRUG-ELUTING STENT |
Manufacturer (Section D) |
BIOTRONIK AG, BUELACH, SWITZERLAND |
ackerstrasse 6 |
buelach CH-81 80 |
CH CH-8180 |
|
Manufacturer Contact |
|
6024 jean road |
lake oswego, OR 97035
|
8772459800
|
|
MDR Report Key | 10115859 |
MDR Text Key | 193710542 |
Report Number | 1028232-2020-02275 |
Device Sequence Number | 1 |
Product Code |
NIQ
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | P170030 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/04/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/24/2021 |
Device Model Number | 364514 |
Device Catalogue Number | SEE MODEL NO. |
Device Lot Number | 03192580 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/04/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/03/2020
|
Initial Date FDA Received | 06/03/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/25/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|