Brand Name | SPECTRANETICS LEAD LOCKING DEVICE |
Type of Device | LLD |
Manufacturer (Section D) |
SPECTRANETICS CORPORATION |
9965 federal dr |
colorado springs CO 80921 |
|
Manufacturer (Section G) |
SPECTRANETICS CORPORATION |
|
|
|
|
Manufacturer Contact |
sondra
chandler
|
9965 federal dr |
colorado springs, CO 80921
|
719447-253
|
|
MDR Report Key | 4606629 |
MDR Text Key | 5765094 |
Report Number | 1721279-2015-00042 |
Device Sequence Number | 1 |
Product Code |
DRB
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K043401 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Literature,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/24/2015 |
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 | UNKNOWN |
Device Catalogue Number | UNKNOWN |
Device Lot Number | UNKNOWN |
Other Device ID Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/24/2015 |
Initial Date FDA Received | 03/16/2015 |
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 | FINELINE 4470 LEAD (IMPL. 66 MO); EASYTRACK2 4542 LEAD (IMPL. 66 MO); SOLUTE 4294 RA LEAD (IMPL. 202 MO); SPECTRANETICS LASER SHEATH; SOLUTE 4285 LEAD (IMPL. 202 MO); ENDTAK G 0185 LEAD (IMPL. 66 MO) |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 55 YR |
Patient Weight | 51 |