MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-06 for SPECTRANETICS LEAD LOCKING DEVICE 518-067 manufactured by The Spectranetics Corporation.
[178344184]
Patient's date of birth unavailable.
Patient Sequence No: 1, Text Type: N, H10
[178344185]
A lead extraction procedure commenced to remove two leads: a right atrial (ra) lead and a right ventricular (rv) lead due to infection. Among other devices, two spectranetics lead locking devices (lld's) were inserted into the rv and ra leads to use for lead traction to aid in removal. The ra was successfully removed first, with no complications. However, during the attempt to remove the rv lead, the patient's blood pressure dropped and cardiac tamponade was noted. Rescue efforts began immediately, including pericardiocentesis which drained 200cc. After this intervention, the patient was stable and was transferred to icu. Both leads were successfully removed. There was no reported malfunction of any spectranetics device used in the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00025 |
| MDR Report Key | 9677798 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-10 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-02-06 |
| 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 | 2020-02-06 |
| Model Number | 518-067 |
| Catalog Number | 518-067 |
| Lot Number | FLP19J20A |
| 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 | 2020-02-06 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-02-06 |