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 |
sondra
chandler
|
9965 federal dr |
colorado springs, CO 80921
|
719447-253
|
|
MDR Report Key | 6223145 |
MDR Text Key | 63879088 |
Report Number | 1721279-2017-00003 |
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 |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
12/09/2016 |
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 | 518-062 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/09/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/09/2016 |
Initial Date FDA Received | 01/04/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 02/03/2017
|
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, MFR UNKNOWN (IMPL.180 MOS); SPECTRANETICS CVX-300 LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 66 YR |
Patient Weight | 72 |