BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3317553 · Received August 29, 2013

    Report

    Report Number
    3007566237-2013-02838
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    August 8, 2013
    Report Date
    August 8, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. PHYSICIAN PRODUCT ID: NE U_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON THE DAY OF THE REPORT, THE PATIENT HAD A REFILL. THE HEALTHCARE PROVIDER (HCP) PUT 19CC OF DRUG IN THE PUMP, BUT THEY WERE ¿HAVING ISSUES¿ WITH THE PHYSICIAN PROGRAMMER UPDATING THE PUMP. TELEMETRY WAS PERFORMED, BUT THE DATE WAS FROM (B)(6) 2013 AND THERE WAS NO NEW INFORMATION ON THE PHYSICIAN PROGRAMMER SCREEN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426543 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1