BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3980439 · Received August 5, 2014

    Report

    Report Number
    3007566237-2014-02184
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS : PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE FIRST TIME THE SURGEON PUT THE PUMP ON TOP OF THE PATIENT¿S RIBS AND SHE HAD TO GO BACK 3 MONTHS LATER TO HAVE A BRAND NEW PUMP IMPLANTED. THE PATIENT COULD NOT FUNCTION WITH IT STICKING OUT OF HER RIBS. AT THE TIME OF THE REPORT THE SYSTEM WAS BEING USED TO DELIVER DILAUDID (HYDROMORPHONE), BUT IT WAS NOT KNOWN WHAT WAS DELIVERED BY THE PUMP AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457354 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention