Brand Name | SPECTRANETICS LEAD LOCKING DEVICE |
Type of Device | LLD EZ |
Manufacturer (Section D) |
SPECTRANETICS CORPORATION |
9965 federal dr |
colorado springs CO 80921 |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
sondra
chandler
|
9965 federal dr |
colorado springs, CO 80921
|
719447-253
|
|
MDR Report Key | 5430558 |
MDR Text Key | 38026823 |
Report Number | 1721279-2016-00018 |
Device Sequence Number | 1 |
Product Code |
DRB
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | P960042 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
01/23/2016 |
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 |
Physician
|
Device Model Number | 518-062 |
Device Catalogue Number | UNKNOWN |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/23/2016 |
Initial Date FDA Received | 02/11/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 05/11/2016 03/23/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/14/2015 |
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 |
Treatment | SPECTRANETICS 12F LASER SHEATH |
Patient Outcome(s) |
Death;
|
Patient Age | 76 YR |