BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4241969 · Received November 10, 2014

    Report

    Report Number
    3007566237-2014-03284
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 27, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD GONE THROUGH ¿AN ASSORTMENT OF AVAILABLE MEDICATIONS FOR THE PUMP, WITH LITTLE TO NO RELIEF AS THE YEARS PASSED.¿ THE FIRST PUMP HAD BEEN REPLACED, DUE TO THE PATIENT¿S BODY TYPE, WHEN A SMALL MODEL CAME OUT (ABOUT 9 MONTHS AFTER IMPLANTATION). THE SECOND PUMP WAS REPLACED AFTER THE BATTERY RAN OUT 7 YEARS LATER. IT WAS SUBSEQUENTLY REPORTED THAT THE PATIENT HAD EXPERIENCED ¿ONE FAILURE OF A PUMP,¿ AND THE HCP (HEALTHCARE PROVIDER) REPLACED IT. THE DRUG THE PUMP WAS BEING USED TO INFUSE WAS UNKNOWN. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723980 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention