FDA Adverse Event
Other
Summary report: N
STARBURST XL, 9 ARRAY, 3-5CM, 15CM
MDR report key: 1051774
·
Received May 19, 2008
Report
- Report Number
- 1056436-2008-00021
- Event Type
- Other
- Date Received
- May 19, 2008
- Date of Event
- April 18, 2008
- Report Date
- May 19, 2008
- Manufacturer
- ANGIODYNAMICS, INC.
- Product Code
- GEI
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AFTER REGIONAL ANESTHESIA, RFA WENT ON TO 80, THE PT FELT ELECTRIC SHOCKS FLU. THE DOCTOR OF INTERVENTION DEPT. RE-SETUP THE POWER TO 80W AND TARGET TEMP TO 90. THE PT FELT ELECTRIC SHOCKS FLU TOO. SO, THE DOCTOR OF INTERVENTION DEPT. DECIDED TO STOP RFA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARBURST XL, 9 ARRAY, 3-5CM, 15CM | ELECTROSURGICAL DEVICE | GEI | ANGIODYNAMICS, INC. | NA | 944349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |