BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CCM OPTIMIZER SMART 1PG MODEL X10

    MDR report key: 20269399 · Received September 19, 2024

    Report

    Report Number
    MW5159812
    Event Type
    Injury
    Date Received
    September 19, 2024
    Date of Event
    March 1, 2023
    Report Date
    September 17, 2024
    Manufacturer
    IMPULSE DYNAMICS USA INC
    Product Code
    QFV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CCM DEVICE WAS PLACED IN ME AND WITHIN 3 MONTHS THE LEADS SHORTED CAUSING SEVERE PAIN AND SHOCKS. THEY TURNED OFF 1 LEAD AND WITHIN WEEKS THE DEVICE ITSELF STARTED SHORTING, CAUSING DILATION OF VEINS AND UNCONTROLLED MUSCLE SPASMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450284 CCM OPTIMIZER SMART 1PG MODEL X10 IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA INC CCMX10 BD00026531

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other| R AMIODARONE.| ANORO ELLIPTA.| ASPIRIN. | ATORVASTATIN.| CARVEDILOL.| ENTRESTO.| FUROSEMIDE. | ISOSORBIDE.| MULTIVITAMIN.| PACEMAKER DEFIBRILLATOR. | PANTOPRAZOLE.| PLAVIX.| POTASSIUM.| RANEXA.| SPIRONOLACTONE.| SUPER B COMPLEX.| VITAMIN C.| VITAMIN D3.