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 | 4672203 |
MDR Text Key | 18544804 |
Report Number | 1721279-2015-00057 |
Device Sequence Number | 1 |
Product Code |
DRB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K043401 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative,company representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/27/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/09/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 01/12/2017 |
Device Model Number | 518-062 |
Device Catalogue Number | 518-062 |
Device Lot Number | FLP15A12A |
Other Device ID Number | SEE H10 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/25/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/12/2015 |
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 | MDT 4024 RV CARDIAC LEAD (IMPL. 246MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE EZ; MDT 4524 RA CARDIAC LEAD (IMPL. 246MO) |
Patient Outcome(s) |
Hospitalization;
Other;
Required Intervention;
|
Patient Age | 67 YR |
Patient Weight | 93 |