FDA Adverse Event
Injury
Summary report: N
*
MDR report key: 443987
·
Received February 20, 2003
Report
- Report Number
- 2242056-2003-00002
- Event Type
- Injury
- Date Received
- February 20, 2003
- Date of Event
- December 26, 2002
- Report Date
- February 19, 2003
- Manufacturer
- ALTO DEVELOPMENT CORP./DBA A&E MEDICAL CORP.
- Product Code
- LDF
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
CORONARY BYPASS PT EXPERIENCED TEAR IN ATRIUM AT TEMPORARY CARDIAC PACING WIRE ATTACHMENT SITE. THE PACING WIRE WAS REATTACHED TO THE INFERIOR VENA CAVA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | LDF | ALTO DEVELOPMENT CORP./DBA A&E MEDICAL CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |