BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4182261 · Received October 17, 2014

    Report

    Report Number
    3007566237-2014-03021
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: 2014-(B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN DEPLOYING THE ANCHOR FROM THE 8781 CATHETER KIT, THE TRAILING END OF THE ANCHOR BUNCHED UP LIKE AN ACCORDION OVER THE CATHETER, WHICH REQUIRED AN 8785 ACCESSORY KIT TO BE OPENED. NEUROSURGEON CUT OFF BUNCHED UP ANCHOR WITH TOOL FROM KIT AND THEN SUCCESSFULLY RE-DEPLOYED THE ANCHOR FROM THE 8785 KIT. THE DEVICE WOULD NOT BE RETURNED AS IT WAS THROWN IN THE GARBAGE CAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662305 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR