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 | 6038192 |
MDR Text Key | 57779779 |
Report Number | 1721279-2016-00148 |
Device Sequence Number | 1 |
Product Code |
DRB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K990713 |
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 |
09/26/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/18/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 03/15/2018 |
Device Model Number | 518-019 |
Device Catalogue Number | 518-019 |
Device Lot Number | FLC16C15B |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/24/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | CARDIAC LEAD BSC 0134-64 (IMPL. 204 MOS.); CARDIAC LEAD BSC 4439 (IMPL. 204 MOS.); CARDIAC LEAD MDT 3830 (IMPL. 120 MOS.); CARDIAC LEAD MDT 4194 (IMPL. 96 MOS.); SPECTRANETICS CVX-300 LASER SYSTEM; SPECTRANETICS LASER SHEALTH II |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Other;
Required Intervention;
|
Patient Age | 56 YR |