BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INFUSION PUMP

    MDR report key: 3781545 · Received April 30, 2014

    Report

    Report Number
    3007566237-2014-01190
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURER REPORT #3004209178-2012-10567. UPON FURTHER REVIEW THE INFORMATION IN REGARD TO THE PATIENT¿S INFECTION POST-REPLACEMENT NO LONGER APPLIES TO MANUFACTURER REPORT # 3004209178-2012-10567. ANY FURTHER INFORMATION INVOLVING THE PATIENT¿S INFECTION WILL BE REPORTED UNDER THIS MANUFACTURE¿S REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ¿REMOVED APPROXIMATELY 3 MONTHS AFTER IMPLANT DUE TO INFECTION¿. IT WAS NOTED THAT THERE WAS ¿NO OLD PUMP PRESENT AT THE TIME OF CURRENT IMPLANT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259684 UNKNOWN INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention