BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 4240916 · Received November 10, 2014

    Report

    Report Number
    3007566237-2014-03280
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP ALARMED THE MONTH PRIOR TO THE DATE OF THIS REPORT BECAUSE SHE WENT PAST HER REFILL DATE. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) WAS SEMI-RETIRED SO IT WAS HARD TO GET TO HIM IN TIME TO SEE HIM. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT PROVIDED. ADDITIONAL INFORMATION INCLUDING IF ANY PATIENT SYMPTOMS OCCURRED, WHAT ACTIONS OR INTERVENTIONS OCCURRED AND THE PATIENT¿S OUTCOME HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721911 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR