Brand Name | SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM |
Type of Device | BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - GALWAY |
|
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC - GALWAY |
|
|
|
|
Manufacturer Contact |
sonali
arangil
|
one scimed place |
maple grove, MN 55311
|
7634941700
|
|
MDR Report Key | 7593872 |
MDR Text Key | 110847451 |
Report Number | 2134265-2018-05237 |
Device Sequence Number | 1 |
Product Code |
NIQ
|
UDI-Device Identifier | 08714729840435 |
UDI-Public | 08714729840435 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P150003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/22/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/09/2019 |
Device Model Number | H7493926038400 |
Device Catalogue Number | 39260-3840 |
Device Lot Number | 0021868799 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/22/2018 |
Initial Date FDA Received | 06/12/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/09/2018 |
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 |