BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3202418 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01046
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    April 12, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. PATIENT REPORTED A DIFFERENT PATIENT WHO EXPERIENCED WITHDRAWAL IF NOT REFILLED EVERY MONTH. PATIENT OUTCOME NOT REPORTED. UNKNOWN DRUG IN THE PUMP. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303094 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other