FDA Adverse Event
Injury
Summary report: N
NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
MDR report key: 2963701
·
Received February 15, 2013
Report
- Report Number
- 2029046-2013-00015
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- September 2, 2012
- Report Date
- January 25, 2013
- Manufacturer
- BIOSENSE WEBSTER, INC (IRWINDALE)
- Product Code
- DRF
- PMA / PMN Number
- P990025
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SINCE NO SPECIFIC DEVICE MFG#/ MODEL# AS WELL AS LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT POST PAROXYSMAL (B)(4) CLINICAL STUDY PROCEDURE THE PATIENT HAD TO BE HOSPITALIZED (4 DAYS) FOR SPITTING OUT BLOOD. NO PATIENT ETIOLOGY WAS RECOGNIZED APART FROM POSSIBILITY OF EMPHYSEMA. CHEST SCAN AND BRONCHIAL BIOPSY WERE PERFORMED. THIS ADVERSE EVENT WAS STATED TO BE UNANTICIPATED. THE CAUSALITY WAS CLASSIFIED AS POSSIBLY PROCEDURE; DEVICE AND DRUG RELATED. THE OUTCOME PROGNOSIS WAS EXCELLENT. THE ADVERSE EVENT HAD BEEN RESOLVED WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69332 | NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER | CATHETER, ELECTRODE RECORDING | DRF | BIOSENSE WEBSTER, INC (IRWINDALE) | NAVISTAR TC | UNKNOWN_NAVISTAR TC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |