FDA Adverse Event
Death
Summary report: N
LEVEEN NEEDLE ELECTRODE
MDR report key: 230056
·
Received June 30, 1999
Report
- Report Number
- 2953184-1999-00003
- Event Type
- Death
- Date Received
- June 30, 1999
- Date of Event
- June 14, 1999
- Report Date
- June 29, 1999
- Manufacturer
- RADIOTHERAPEUTICS CORP.
- Product Code
- JOS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DEVICE WAS USED IN A PROCEDURE ON JUNE 8, 1999. NO BLEEDING WAS NOTED AT THE TIME AND THE PATIENT WAS SENT TO RECOVERY. ON JUNE 13 (FIVE DAYS AFTER THE PROCEDURE) THE PATIENT WAS FOUND TO BE ASHEN IN COLOR, WITH LOW OXYGEN SATRUATION. THE PATIENT HAD A CARDIOPULMONARY ARREST IN THE SICU, BUT WAS RESUSCITATED. A CT SCAN FOUND A SUB DIAPHRAGMATIC MASS WITH RIGHT ATRIAL COMPRESSION. EMERGENCY SURGERY WAS PERFORMED, BUT HER RIGHT HEART FAILURE WAS IRREVERSIBLE. THE PATIENT DIED ON JUNE 14, 1999.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEVEEN NEEDLE ELECTRODE | NEEDLE ELECTRODE | JOS | RADIOTHERAPEUTICS CORP. | LE3515 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Death | OPEN SURGICAL PROCEDURE, GENERAL ANESTHESIA USED. |