MIRADRY SYSTEM

Description of Event or Problem

PATIENT REPORTED PAIN AND NUMBNESS IN CENTRAL LEFT AXILLA TO INNER SIDE OF ELBOW SINCE MIRADRY TREATMENT THAT EXTENDED TO FINGERTIPS 3 MONTHS POST TREATMENT, DESCRIBED AS PRESSURE ON FINGERS.

Additional Manufacturer Narrative

THERE WAS NO DEVICE ISSUE REPORTED. BASED ON THE INFORMATION PROVIDED, THIS INCIDENT HAS BEEN DETERMINED TO BE A RARE RISK OF THE PROCEDURE WITH NO EVIDENCE OF DEVICE MALFUNCTION. PATIENT WAS REPORTED TO HAVE LOW BMI. PATIENTS WITH VERY LITTLE TO NO SUBCUTANEOUS FAT IN THE AXILLA ARE AT HIGHER RISK FOR NERVE-RELATED INJURIES, BECAUSE THERE IS A GREATER LIKELIHOOD THAT ONE OR MORE BRANCHES OF THE BRACHIAL PLEXUS MAY BE IN CLOSE PROXIMITY TO THE TARGET AREA. THIS INFORMATION IS INCLUDED IN PRODUCT LABELING AND USER TRAINING. REPORTED FREQUENCY OF NERVE INJURIES ARE WITHIN EXPECTED RATES AS SPECIFIED IN THE RISK MANAGEMENT FILE AND DOCUMENTED IN POST MARKET SURVEILLANCE DATA.