BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PUMP

    MDR report key: 3202395 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01114
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    February 3, 2012
    Report Date
    March 2, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRITICAL ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. THE CRITICAL ALARM WAS DUE TO A ZERO ML RESERVOIR VOLUME REACHED. THE PATIENT WAS TO BE SCHEDULED FOR A REFILL ON (B)(6)-2012, BUT WAS NOT REFILLED UNTIL (B)(6)-2012. THE LOW RESERVOIR ALARM DATE WAS SAID TO BE (B)(6)-2012. DRUG: BACLOFEN, 800 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301021 UNKNOWN PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1