BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYMEDICA ORTHOPEDICS E-VIVE

    MDR report key: 10920525 · Received November 30, 2020

    Report

    Report Number
    3011466827-2020-00004
    Event Type
    Injury
    Date Received
    November 30, 2020
    Date of Event
    October 29, 2020
    Report Date
    November 5, 2020
    Manufacturer
    CYMEDICA ORTHOPEDICS, INC.
    Product Code
    IPF
    UDI-DI
    00854691008834
    PMA / PMN Number
    K163067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OBSERVED TRAUMA IS INDICATIVE OF AN ACUTE LOCALIZED INCREASE IN CURRENT DENSITY AS A RESULT OF LOSS OF PAD CONDUCTIVITY ACROSS ITS SURFACE AREA. MANY POTENTIAL SOURCES EXIST OF ACCIDENTAL HIGH CURRENT DENSITIES. WRINKLES OR BREAKS IN ELECTRODE CONDUCTORS, NON-UNIFORM GEL LAYER OR DAMAGE, DRYING OUT, ELECTRODES PARTIALLY PEELING OFF THE SKIN (LOSS OF ADHESION), INCORRECT ELECTRODE PLACEMENT AND ELECTRODE DESIGN CAN CREATE PREFERENTIAL CURRENT THROUGH A REDUCED SURFACE AREA INTO THE PATIENT RESULTING UNSAFE CURRENT DENSITIES AND SUBSEQUENT TISSUE DAMAGE. THIS CAN OCCUR EVEN AT SAFE THERAPEUTIC IMPULSES DUE TO THE REDUCTION OF THE CONDUCTIVE SURFACE AREA RESULTING IN UNSAFE CURRENT DENSITIES. IN THE ABSENCE OF THE PHYSICAL COMPLAINT DEVICE TO INVESTIGATE, PHOTO AND TESTIMONY EVIDENCE WAS INVESTIGATED AS FOLLOWS: THE COMPLAINT DEVICE ELECTRODE PHOTOS WERE EXAMINED AS FOLLOWS: WRINKLES: NO SIGN OF DAMAGE. BREAKS: NO SIGN OF DAMAGE. GEL: SUBSTANTIAL PERIMETER DAMAGE INDICATIVE OF EXCESSIVE USE AND POOR MAINTENANCE DRYNESS: PHOTOS ARE COMMENSURATE WITH DRY ELECTRODES. ADHESION: PHOTOS ARE COMMENSURATE WITH COMPROMISED ADHESION DUE TO DRYNESS. INCORRECT ELECTRODE PLACEMENT: UNKNOWN, PHOTOS OF INJURIES SUGGEST CORRECT PLACEMENT ON LEG. THE COMPLAINT DEVICE WAS EXAMINED FOR: GARMENT INSPECTED, NO ABNORMALITIES. FAULT CONDITIONS, NO OVERVOLTAGE FAULTS REPORTED. ROOT CAUSES: PATIENT NEGLIGENCE OF REPLACING DRY ELECTRODES. AS THE ELECTRODES ARE USED, MOISTURE IS LOST DUE TO THERMAL HEATING. CONSEQUENTLY, INCREASING RESISTANCE, WHICH THEN REQUIRES ELEVATED INTENSITY LEVELS TO ACHIEVE STRONG CONTRACTIONS. THIS LEADS TO A GREATER ELECTRICAL POTENTIAL AND THUS A PROPENSITY OF HIGHER CURRENT DENSITIES. PATIENT NEGLIGENCE OF USING ELECTRODE GEL TO FACILITATE CURRENT DENSITY DISTRIBUTION AT HIGHER THERAPY LEVELS.

    Description of Event or Problem · 1

    ON (B)(6) 2020 PATIENT CONTACTED CYMEDICA CUSTOMER SERVICE REGARDING BURNS HE RECEIVED FROM THE ELECTRODES. THE "BURN" MARKS ARE HEALED NOW; PLEASE TAKE NOTE THAT HE USED THE SAME SET OF PADS SINCE LATE AUGUST. THE PATIENT DID NOT USE GEL. CUSTOMER SERVICE SHIPPED HIM NEW ELECTRODES AND RE-EDUCATED HIM ON USE/CARE ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387799 CYMEDICA ORTHOPEDICS E-VIVE CYMEDICA ORTHOPEDICS® E-VIVE¿ IPF CYMEDICA ORTHOPEDICS, INC. CY-1000-310 0214885-0147 00854691008834

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other