BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 3203591 · Received July 3, 2013

    Report

    Report Number
    3007566237-2013-01073
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    July 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HAD ¿GOT SOME AIR IN IT¿ AND THE HEALTH CARE PROFESSIONAL HAD DIFFICULTY ASPIRATING THE PUMP. THE PATIENT OUTCOME WAS UNKNOWN. THE DRUG BEING DELIVERED IN THE PUMP WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304211 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8627

    Patients

    Seq Age Sex Outcome Treatment
    1