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 2020-02-19 for SPECTRANETICS LEAD LOCKING DEVICE 518-062 manufactured by The Spectranetics Corporation.
[180211601]
A lead extraction procedure commenced to remove one right atrium (ra) lead and one right ventricle (rv) lead due to chronic pain and occlusion. The rv lead was targeted for extraction first. A 16f spectranetics glidelight laser sheath and spectranetics ez lld were used to extract the rv lead. During the extraction the rv lead became stuck, so the physician elected to stop removing the rv lead and begin removing the ra lead. The 16f glidelight and ez lld were used to extract the ra lead. Traction was put on the ra lead which removed the lead successfully, however in the process of putting traction on the lead, a hole was created in the ra and an effusion was noted. A sternotomy was performed to repair the ra tear. The ra tear was repaired successfully, and the patient was stabilized. The rv lead was not extracted. There was no alleged malfunction of any spectranetics devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00039 |
| MDR Report Key | 9729861 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-19 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-30 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-19 |
| 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. SARAH BREVIG |
| 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 | 2020-02-19 |
| Model Number | 518-062 |
| Catalog Number | 518-062 |
| Lot Number | FLP19K23A |
| 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 | 2020-02-19 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-02-19 |