MIRADRY SYSTEM
Received Jul 31, 2024 · Event occurred Dec 1, 2023
Report 3008082710-2024-70013 · MDR key 19878922
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Nerve Damage
- Nerve Damage
Narrative
Description of Event or Problem
42-YEAR-OLD MALE, TREATED WITH MIRADRY IN (B)(6) 2023 FOR THE FIRST TIME. VERY SEVERE, INCOMPLETE, GRADE III AXONOTMESIS OF THE LATERAL CORD OF THE BRACHIAL PLEXUS, WHICH EXPLAINS SENSORY DISTURBANCES OF THE MEDIAN NERVE AFFECTING THE THUMB AND INDEX FINGER, AS WELL AS, COMPLETE ABSENCE OF RESPONSE OF THE RIGHT LATERAL CUTANEOUS ANTEBRACHIAL NERVE IN THE FOREARM. DENERVATION IN THE BICEPS BRACHII MUSCLE CLINICALLY SHOWING AMYOTROPHY WITH SEVERE PARESIS DERIVED FROM INCOMPLETE GRADE III AXONOTMESIS OF THE LATERAL CORD OF THE RIGHT BRACHIAL PLEXUS. INJURY IN THE TERMINAL EXTENSION OF THE RIGHT MEDIAN NERVE JUSTIFYING PARTIAL GRADE III AXONOTMESIS OF THE EVOKED MOTOR RESPONSES IN THE THENAR EMINENCE OF THE RIGHT HAND. POOR EVOLUTIONARY PROGNOSIS IN THE SHORT AND MEDIUM TERM FOR THE MOTOR AND SENSORY TERRITORY OF THE MUSCULOCUTANEOUS NERVE AND THE SENSORY FASCICLES OF THE LATERAL CORD THAT WILL FORM THE DIGITAL SENSORY FIBERS OF THE RIGHT HAND, THUMB, AND INDEX FINGER.