FDA Adverse Event
Summary report: N
TEMPORARY CARDIAC PACING WIRE
MDR report key: 1161124
·
Received September 5, 2008
Report
- Report Number
- 1161124
- Date Received
- September 5, 2008
- Date of Event
- June 19, 2008
- Report Date
- August 29, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- LDF
- Report Source
- User Facility report
- Reporter Location
- MA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THIS INFANT PATIENT, WITH TRANSITIONAL AV CANAL, PRESENTED EARLIER THIS YEAR FOR SURGICAL REPAIR OF CONGENITAL HEART DEFECT. THE PATIENT UNDERWENT REPAIR OF TRANSITIONAL ATRIOVENTRICULAR CANAL WITH PRIMARY CLOSURE OF VENTRICULAR COMPONENT AND PERICARDIAL PATCH CLOSURE OF ATRIAL COMPONENT OF THE CANAL DEFECT AND COMPLETE CLEFT CLOSURE. ONE TEMPORARY VENTRICULAR PACING WIRE WAS PLACED INTRAOPERATIVELY. THE PATIENT DID NOT REQUIRE POSTROPERATIVE PACING AND THE WIRE WAS NOT USED. A CXR WAS DONE 4 DAYS LATER, PRIOR TO THE TEMPORARY PACER WIRE REMOVAL, WHICH REVEALED A "CURVILINEAR METALLIC STRUCTURE AT THE INFERIOR HEART BORDER." THE TEMPORARY PACING WIRE WAS DISCONTINUED WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEMPORARY CARDIAC PACING WIRE | LEAD PACEMAKER, TEMPORARY | LDF | ETHICON, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 MO | NO OTHER THERAPIES| NO OTHER THERAPIES |