FDA Adverse Event
Injury
Summary report: N
BIOSENSE WEBSTER THERMOCOOL CATHETER
MDR report key: 824601
·
Received March 7, 2007
Report
- Report Number
- 2029046-2007-00030
- Event Type
- Injury
- Date Received
- March 7, 2007
- Date of Event
- February 1, 2007
- Report Date
- March 7, 2007
- Manufacturer
- BIOSENSE WEBSTER, INC.
- Product Code
- DRF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD MYOCARDIAL INFARCTION WHICH WAS LINKED TO AN OCCLUSION OF THE CIRCUMFLEX ARTERY. MEDICAL INTERVENTION WAS PERFORMED TO PREVENT MODERATE TRANSIENT IMPAIRMENT, BUT ACTUAL TREATMENT WAS NOT SPECIFIED. IT WAS REPORTED THAT THE EVENT WAS PROCEDURE RELATED. PROGNOSIS FOR THE PATIENT WAS REPORTED TO BE SATISFACTORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSENSE WEBSTER THERMOCOOL CATHETER | ELECTROPHYSIOLOGY CATHETER | DRF | BIOSENSE WEBSTER, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Life Threatening |