FDA Adverse Event
Injury
Summary report: N
*
MDR report key: 47389
·
Received October 23, 1996
Report
- Report Number
- 47389
- Event Type
- Injury
- Date Received
- October 23, 1996
- Report Date
- October 21, 1996
- Manufacturer
- COOK PACEMAKER CORP.
- Product Code
- LJT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACCORDING TO THE PT, AFTER INFUSION DIFFICULTY ABOUT 12 MONTHS POST IMPLANT, CATHETER FRACTURE WITH EMBOLIZATION OF THE DISTAL SEGMENT TO THE PULMONARY ARTERY WAS DIAGNOSED AND THE SEGMENT SUCCESSFULLY RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | CPC VITAL-PORT | LJT | COOK PACEMAKER CORP. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Hospitalization| R | NOT AVAILABLE |