BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3203133 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01138
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    October 10, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALTHCARE PROFESSIONAL (HCP) OBSERVED CRYSTALLIZATION OF BUPIVACAINE, CONCENTRATIONS HIGHER THAN 35MG/ML, THAT OCCURRED OVER A PERIOD OF YEARS. THE HCP STATED ¿IT COULD BE A LOT OF GUNK IN THE PUMP¿. THE HCP LATER STATED THAT THE ONLY THING HE COULD RECALL WAS THAT THE CRYSTALLIZATION ONLY HAPPENED THAT ONE TIME. THE HCP STATED THAT HE HAS NEVER HAD ANY OTHER ISSUES WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301410 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1