LEVEEN SUPERSLIM NEEDLE ELECTRODE
Received May 27, 2009 · Event occurred Sep 19, 2005
Report 3005099803-2008-01836 · MDR key 1393031
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Burn, Thermal
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2005, THAT A LEVEEN SUPERSLIM NEEDLE ELECTRODE DEVICE WAS USED DURING A THERMO ABLATION OF OSTEOMA PROCEDURE PERFORMED ON THE SAME DAY, (PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE PATIENT WAS BURNED AT THE SITE OF THE NEEDLE INTRODUCTION. THE PROCEDURE WAS STOPPED PRIOR TO ROLL OFF. ANTISEPTIC CREAM WAS APPLIED TO THE PATIENT, THE CONDITION WAS REPORTED AS "GOOD".
Additional Manufacturer Narrative
ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN.