BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4111639 · Received September 23, 2014

    Report

    Report Number
    3007566237-2014-02674
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT WITH 5 MILLILITER RESIDUALS WHO HAD BEEN FOLLOWED FOR YEARS. IT WAS ¿A STABLE SITUATION.¿ INFORMATION REGARDING THE PATIENT IDENTITY, DEVICES INVOLVED, DRUG IN THE PUMP, CAUSE OF THE DISCREPANCIES, OR PATIENT OUTCOME WERE NOT REPORTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591571 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1