BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3112832 · Received May 14, 2013

    Report

    Report Number
    3007566237-2013-01617
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAD BEEN A POCKET FILL WITH A PATIENT WHO LET THE PUMP RUN DRY. THE PUMP HAD ALARMED BUT THE PATIENT CLAIMED IT WAS NOT HEARD BECAUSE OF A HEARING PROBLEM. WHEN THE PUMP WAS REFILLED THERE WAS A POCKET FILL. THE 'INEXPERIENCED' PERSON REFILLING THE PUMP DID NOT REALIZE THEY WERE NOT IN THE PUMP. NO FURTHER DETAILS COULD BE PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212252 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other