BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4133293 · Received October 1, 2014

    Report

    Report Number
    3007566237-2014-02802
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8703, LOT# J92103160, IMPLANTED: (B)(6) 1993, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LAST PUMP CHANGE IN 2008, THEY WERE DELAYED BY 6 MONTHS TO GET THE PUMP. WHEN IT WAS IMPLANTED THE MANUFACTURE REPRESENTATIVE PROGRAMMED THE PUMP AND THE NUMBING MEDICATION WORKED TOO FAST AND THE PATIENT BROKE 2 TOES WHEN THE PERSON SHOVED ON THE PATIENT'S SNEAKER. BY THE TIME THE PATIENT GOT HOME, THEIR CALF MUSCLE HURT AND THEY COULDN¿T MOVE. THE HEALTHCARE PROVIDER HAD TO TURN THE PUMP DOWN 3 TIMES AND FINALLY ALL THE MEDICATION WAS REMOVED AND THE PATIENT WAS REFILLED AGAIN. (NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610791 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Other