N
Patient 1
PATIENT WEIGHT UNAVAILABLE.
MAUDE MDR 9591297
- MDR report key
- 9591297
- Report number
- 1721279-2020-00013
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-12-19
- Date received
- 2020-01-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. BARBARA CREEL
- Address
- 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US
- Phone
- 719-719-7194
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SPECTRANETICS 14F GLIDELIGHT LASER SHEATH | GLIDELIGHT | THE SPECTRANETICS CORPORATION | MFA | 500-302 | 500-302 | FGB19J21A | N | ||||
| 101 | --- |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-15 | 0 | 1. H; 2. L; 3. R |
Event Narratives#
D
Patient 1
A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE ONE RIGHT ATRIAL (RA) LEAD DUE TO NON FUNCTION. AFTER THE RA LEAD WAS SUCCESSFULLY EXTRACTED, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING STERNOTOMY. A SUPERIOR VENA CAVA (SVC) INJURY WAS DISCOVERED. THE PHYSICIAN REPAIRED THE INJURY AND THE PATIENT SURVIVED THE PROCEDURE. THERE WAS NO REPORTED MALFUNCTION WITH ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.