FDA Adverse Event
Death
Summary report: N
CARTO XP EP NAVIGATION SYSTEM
MDR report key: 839599
·
Received April 19, 2007
Report
- Report Number
- 2029046-2007-00052
- Event Type
- Death
- Date Received
- April 19, 2007
- Date of Event
- March 23, 2007
- Report Date
- April 19, 2007
- Manufacturer
- BIOSENSE WEBSTER, INC.
- Product Code
- DQK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE PHYSICIAN IS OF THE OPINION THAT THE CAUSE OF THE EVENT WAS OWING TO THE PATIENT'S PRE-EXISTING CONDITION AND NOT OWING TO THE MAPPING THAT WAS PERFORMED.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT THE PATIENT HAD SEVERE VENTRICULAR DYSFUNCTION PRIOR TO, THE PROCEDURE AND THAT HE BECAME SEVERELY HYPOTENSIVE AND HIS RHYTHM DEGENERATED TO VENTRICULAR FIBRILLATION DURING MAPPING. IT WAS REPORTED THAT ALL EFFORTS TO STABILIZE AND RESUSCITATE THE PATIENT FAILED AND THE PATIENT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARTO XP EP NAVIGATION SYSTEM | CARDIAC ELECTROPHYSIOLOGY MAPPING SYSTEM | DQK | BIOSENSE WEBSTER, INC. | CP-4055-00 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Death |