Brand Name | SPECTRANETICS LEAD LOCKING DEVICE |
Type of Device | LLD |
Manufacturer (Section D) |
SPECTRANETICS |
9965 federal dr. |
colorado springs CO 80921 |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
barbara
creel
|
9965 federal drive |
colorado springs, CO 80921
|
719447-246
|
|
MDR Report Key | 6159365 |
MDR Text Key | 62099753 |
Report Number | 1721279-2016-00189 |
Device Sequence Number | 1 |
Product Code |
DRB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K142116 |
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 |
11/17/2016 |
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 Expiration Date | 06/30/2016 |
Device Model Number | 518-062 |
Device Catalogue Number | 518-062 |
Device Lot Number | FLP16F30A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/17/2016 |
Initial Date FDA Received | 12/09/2016 |
Supplement Dates Manufacturer Received | Not provided 07/24/2017
|
Supplement Dates FDA Received | 03/23/2017 08/09/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/30/2016 |
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 CVX-300 LASER SYSTEM |
Patient Outcome(s) |
Other;
|
Patient Age | 70 YR |