MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-27 for SPECTRANETICS LEAD LOCKING DEVICE 518-062 manufactured by The Spectranetics Corporation.
[184073165]
Patient date of birth unavailable. Patient weight unavailable.
Patient Sequence No: 1, Text Type: N, H10
[184073166]
A lead extraction procedure commenced to remove a non-functioning lead in the right atrium (ra). The physician was using a spectranetics glidelight laser sheath and a spectranetics lead locking device to extract the ra lead. After the lead was pulled back, an effusion was noted. The physician tried to drain the pericardium with no success and then made a subxiphoid cut. He observed excessive amounts of blood and decided to proceed with a sternotomy. After the chest was opened, the physician saw a small hole in the atrium that had already clotted and the physician repaired the tear with suture. The patient made a full recovery and there was no reported malfunction of any spectranetics products used during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00043 |
| MDR Report Key | 9766024 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-02-11 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE WORFORD |
| Manufacturer Street | 9965 FEDERAL DRIVE |
| Manufacturer City | COLORADO SPRINGS CO 80921 |
| Manufacturer Country | US |
| Manufacturer Postal | 80921 |
| Manufacturer Phone | 719447-246 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRANETICS LEAD LOCKING DEVICE |
| Generic Name | LLD |
| Product Code | DRB |
| Date Received | 2020-02-27 |
| Model Number | 518-062 |
| Catalog Number | 518-062 |
| Lot Number | FLP18E21A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE SPECTRANETICS CORPORATION |
| Manufacturer Address | 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921 |
| Product Code | --- |
| Date Received | 2020-02-27 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-02-27 |