MIRADRY SYSTEM

Description of Event or Problem

PATIENT REPORTED PERSISTENT NUMBNESS ALONG THE UNDERSIDE OF THE LEFT ARM FROM THE AXILLA DOWN TO THE HAND, ALONG WITH ONGOING NEUROPATHIC SENSATIONS AND REDUCED MOTOR FUNCTION IN FINGERS. THE INDEX AND MIDDLE FINGERS AND THUMB REMAIN WEAK AND DIFFICULT TO CLOSE, SIGNIFICANTLY AFFECTING ABILITY TO GRIP OBJECTS AND TYPE. ONGOING ELECTRIC SHOCKS IN FINGERS AFFECT DAY AND ABILITY TO SLEEP. PATIENT REPORTED EXPERIENCING A SUDDEN AND VERY INTENSE ELECTRICAL SHOCK SENSATION RADIATING DOWN THE LEFT ARM AND INTO THE HAND DURING THE PROCEDURE. PATIENT ASKED THE PROVIDER TO STOP BRIEFLY BEFORE THE TREATMENT CONTINUED. PATIENT IS FOLLOWING UP WITH TREATING PROVIDER AND SEEKING NEUROLOGICAL EVALUATION. TREATING CLINIC REPORTED PATIENT HAD A LITTLE INCREASE IN MOTION ONE MONTH POST TREATMENT.

Additional Manufacturer Narrative

A REVIEW OF THE EVENT HISTORY LOG DID NOT REVEAL ANY ERROR CODES OR OTHER INFORMATION TO SUGGEST A DEVICE ISSUE CONTRIBUTING TO THE INJURY. A REVIEW OF THE PRODUCTION RECORDS SHOWS THE DEVICE PASSED ALL FINAL INSPECTIONS AND TESTS. NO POSSIBLE DEVICE CAUSE WAS IDENTIFIED. NERVE INJURY IS A RARE KNOWN RISK OF THE PROCEDURE.