BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3191439 · Received June 26, 2013

    Report

    Report Number
    3007566237-2013-02124
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A RETURN OF PAIN. IT WAS BELIEVED THE PATIENT ¿NEEDED A NEW BATTERY.¿ THE PUMP WAS REPLACED. THE PATIENT INDICATED THEY DID NOT WANT SURGERY ¿EVER AGAIN IN MY LIFE.¿ THE PATIENT STATED THEY ¿THOUGHT I WAS GOING TO DIE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291457 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention