LEVEEN SUPERSLIM NEEDLE ELECTRODE
Received May 27, 2009 · Event occurred Nov 16, 2005
Report 3005099803-2008-01837 · MDR key 1393032
Device
Generic name
Jos
Manufacturer
Boston Scientific Corporation-spencerModel number
M001262240Lot number
7587319
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 SURFACE OF S6 - LIVER PROCEDURE PERFORMED ONE DAY PRIOR, (PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, AFTER THE FIFTH ABLATION, THE PHYSICIAN FELT HEAT AT THE HAND AND NOTICED THE PATIENT EXPERIENCED A REDNESS OF THE SKIN WHERE THE METAL PROBE WAS ATTACHED. THE BURN WAS APPROXIMATELY 2-3CM IN SIZE. NO TREATMENT WAS REQUIRED FOR THE BURN. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNIT (MANUFACTURER UNKNOWN). THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "GOOD".
Additional Manufacturer Narrative
THE DEVICE WAS RECEIVED WITH RESIDUE ON THE PLUNGER. NO DAMAGE OR DEFECTS WERE NOTED. THE DEVICE FUNCTIONED AS INTENDED, THE TINES DEPLOYED PROPERLY. NO PROBLEMS WERE DETECTED WITH THE RETURNED DEVICE. A REVIEW OF THE DHR SHOWED NO ANOMALIES. THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN.