BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PUMP

    MDR report key: 3811364 · Received May 15, 2014

    Report

    Report Number
    3007566237-2014-01325
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS RINGING BECAUSE IT ¿NEEDED LOAD¿ SINCE (B)(6). IT WAS REPORTED THE PATIENT WAS NERVOUS, RESTLESS, AND ¿TRANSPIRED (MEANING THE PATIENT WAS SWEATING).¿ THE PUMP WAS USED TO DELIVER LIORESAL. ADDITIONAL INFORMATION REPORTED THE PATIENT¿S HEALTH WAS AT STAKE. PATIENT OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291195 UNKNOWN PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR