FDA Adverse Event
Malfunction
Summary report: N
LEVEEN COACCESS ELECTRODE SYSTEM
MDR report key: 1133494
·
Received August 22, 2008
Report
- Report Number
- 3005099803-2008-03640
- Event Type
- Malfunction
- Date Received
- August 22, 2008
- Date of Event
- May 28, 2008
- Report Date
- July 24, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- JOS
- PMA / PMN Number
- K012315
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A LEVEEN COACCESS ELECTRODE SYSTEM DEVICE WAS TO BE USED FOR A LUNG RADIO FREQUENCY (RF) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, BEFORE STARTING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE COAXIAL INTRODUCER OF THE DEVICE WAS MISSING. NO FURTHER INFORMATION REGARDING PT COMPLICATIONS OR PT CONDITION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEVEEN COACCESS ELECTRODE SYSTEM | JOS | BOSTON SCIENTIFIC CORPORATION | M001262230 | 11290422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |