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 2020-01-10 for SPECTRANETICS LEAD LOCKING DEVICE UNAVAILABLE manufactured by The Spectranetics Corporation.
[174703051]
Device model, lot number, udi and expiration date unavailable. 510k number is unavailable because device model number unavailable. Device manufacture date unavailable.
Patient Sequence No: 1, Text Type: N, H10
[174703052]
A lead extraction procedure commenced to remove one right ventricular (rv) lead due to non function. The case went smoothly until the end of the procedure when the rv lead was successfully extracted. Ten seconds after the lead was removed the patient's blood pressure dropped and rescue efforts commenced immediately, including sternotomy. An rv perforation was discovered. The repair to the rv was successful; the patient survived the procedure. From the report, the lead appeared to have gone through the rv apex; however, a dated ct scan was not available prior to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00010 |
| MDR Report Key | 9575828 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-16 |
| Date of Event | 2019-12-16 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-10 |
| 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 | 2020-01-10 |
| Model Number | UNAVAILABLE |
| Lot Number | UNAVAILABLE |
| 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 | 2020-01-10 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-01-10 |