BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4201633 · Received October 27, 2014

    Report

    Report Number
    3007566237-2014-03114
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8835, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8835, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REFILL DATE ON THE PERSONAL THERAPY MANAGER (PTM) WAS NO ACCURATE AFTER UPDATING THE PUMP AND UTILIZING THE PTM. IT WAS SUGGESTED TO RE-UPDATE THE PUMP WITH THE CLINICIAN PROGRAMMER OR RECOUPLE THE PTM. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN HAD NOT UPDATED THE PHYSICIAN PROGRAMMER, IT WAS AN ERROR ON THE PHYSICIAN PART. IT WAS NOTED THAT EVERYTHING WAS FINE AND THE PATIENT'S PTM WAS SHOWING THE CORRECT REFILL DATE. IT WAS UNKNOWN WHAT THE PUMP WAS INFUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681287 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1