LEVEEN SUPERSLIM NEEDLE ELECTRODE
Received May 27, 2009 · Event occurred Jul 21, 2005
Report 3005099803-2008-01835 · MDR key 1393030
Device
Generic name
Jos
Manufacturer
Boston Scientific Corporation-spencerModel number
M001262290Lot number
6703633
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Fever
Narrative
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 DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. NOT RETURNED.
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 CLINICAL TRIAL PERFORMED IN 2005, (PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED RAPIDLY INCREASING FEVER THE DAY AFTER THE PROCEDURE. THIS CONDITION LASTED 21 DAYS. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS CLOSELY FOLLOWED, WITHOUT TREATMENT, AND AT THE END OF THE THREE WEEKS WAS REPORTED AS "WELL".