BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3201642 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01007
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    February 23, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP STARTED TO ¿WORK ITS WAY¿ THROUGH THE SKIN. THE PUMP WAS EXPLANTED. THE PATIENT WAS HOSPITALIZED FOR A COUPLE OF DAYS UNTIL A NEW PUMP WAS IMPLANTED. IN THE MEANTIME THE PATIENT WAS GIVEN INTRAVENOUS (IV) PERIACTIN AND VALIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303407 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R