POLESTAR FLEXICOIL

Description of Event or Problem

DURING A CRANIOTOMY PROCEDURE IN (B) (6), HOSPITAL USED MEDTRONIC NAVIGATION'S POLESTAR SYSTEM, THE FLEXICOIL WITH ITS ELECTRONIC BOX WAS PLACED ON PATIENT FOREHEAD. SURGERY WAS PERFORMED AS EXPECTED. AFTER SURGERY, IT WAS FOUND UNDER THE ELECTRONIC BOX, THE PATIENT EXPERIENCED A THIRD DEGREE BURN.

Additional Manufacturer Narrative

PATIENT'S WEIGHT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. LOT NUMBER AND DATE OF MANUFACTURE NOT AVAILABLE AS PART WAS DISPOSED BY HOSPITAL. ACTUAL DEVICE NOR LOT NUMBER WAS AVAILABLE. EVALUATION WAS CONDUCTED ON A RANDOM COLLECTION OF FLEXICOILS FROM DIFFERENT BATCHES. UNDER WORST CONDITION TESTING, THE HOTTEST TEMPERATURE RECORDED WAS 44.1 DEGREES CELSIUS.