FDA Adverse Event
Injury
Summary report: N
BIOSENE WEBSTER NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFL
MDR report key: 3111973
·
Received July 24, 2006
Report
- Report Number
- 2029046-2006-00053
- Event Type
- Injury
- Date Received
- July 24, 2006
- Date of Event
- June 28, 2006
- Report Date
- July 24, 2006
- Manufacturer
- BIOSENSE WEBSTER, INC.
- Product Code
- OAD
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO THE FACILITY, THE ADVERSE EVENT WAS PROCEDURE RELATED. (B)(4).
Description of Event or Problem · 1
PATIENT COMPLICATION DURING PROCEDURE WHEN VENTRICULAR TACHYCARDIA WAS INDUCED BY STIMULATOR. REQUIRED MULTIPLE DEFIBRILLATIONS AND CPR. PATIENT UNRESPONSIVE AND INTUBATED. ECHO SHOWED NO TAMPONADE. THE FACILITY REPORTED THAT THE PROGNOSIS FOR THE PATIENT IS SATISFACTORY WITH A SICK HEART. PATIENT WAS LATER DISCHARGED FROM THE HOSPITAL WITH NO RESIDUAL EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSENE WEBSTER NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFL | ELECTROPHYSIOLOGY CATHETER | OAD | BIOSENSE WEBSTER, INC. | D-1197-17-S | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Life Threatening |