Brand Name | SPECTRANETICS LEAD LOCKING DEVICE |
Type of Device | STYLET, CATHETER |
Manufacturer (Section D) |
THE SPECTRANETICS CORPORATION |
9965 federal drive |
colorado springs CO 80921 |
|
Manufacturer (Section G) |
THE SPECTRANETICS CORPORATION |
9965 federal drive |
|
colorado springs CO 80921 |
|
Manufacturer Contact |
barbara
creel
|
9965 federal drive |
colorado springs, CO 80921
|
|
MDR Report Key | 13343876 |
MDR Text Key | 289192795 |
Report Number | 1721279-2022-00011 |
Device Sequence Number | 1 |
Product Code |
DRB
|
UDI-Device Identifier | 00813132023076 |
UDI-Public | (01)00813132023076(17)230727(10)FLP21G27A |
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 |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/04/2022 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/27/2023 |
Device Model Number | 518-062 |
Device Catalogue Number | 518-062 |
Device Lot Number | FLP21G27A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/04/2022 |
Initial Date FDA Received | 01/25/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/27/2021 |
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 | MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 7121 RV ICD LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SUTURE USED FOR TRACTION MANUFACTURER UNK |
Patient Outcome(s) |
Other;
|
Patient Age | 55 YR |
Patient Sex | Male |
Patient Weight | 92 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | Black Or African American |