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 2020-01-07 for SPECTRANETICS LEAD LOCKING DEVICE 518-062 manufactured by The Spectranetics Corporation.
[174125359]
A lead extraction procedure commenced to remove two leads: a right atrial (ra) lead and a right ventricular (rv) lead due to bacteremia. It was reported that the leads were very old, being implanted in 2002. The ra lead was removed successfully with use of a spectranetics 14f glidelight device and a lead locking device (lld). The rv lead was removed with a spectranetics 13f tightrail device and an lld. Approximately 20 seconds after the rv lead released, an injury was noticed in the right ventricle. Rescue efforts were swift and the tear was quickly identified and repaired via sternotomy, without the patient going on bypass. The patient survived the procedure. There was no reported malfunction of any spectranetics devices used during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00003 |
| MDR Report Key | 9559518 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-07 |
| Date of Report | 2019-12-11 |
| Date of Event | 2019-12-11 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-12-11 |
| Date Added to Maude | 2020-01-07 |
| 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 | MRS. BARBARA CREEL |
| 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 | 2020-01-07 |
| Model Number | 518-062 |
| Catalog Number | 518-062 |
| Lot Number | FLP18J24A |
| 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 | 2020-01-07 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-01-07 |