BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 2991673 · Received March 6, 2013

    Report

    Report Number
    3007566237-2013-00700
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP HAD FAILED. IT WAS UNCLEAR HOW OR WHEN THE PUMP HAD FAILED, AND DETAILS WERE NOT PROVIDED FOR WHEN THE PUMP WAS IMPLANTED OR EXPLANTED. IT WAS STATED THAT THE PATIENT'S PUMP WAS PUT IN "IN THE PAST MONTH". THE PATIENT WAS NOTED TO HAVE BEEN CRITICALLY ILL. THE MEDICATION USED WITHIN THE SYSTEM WAS GABLOFEN. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED. [PLEASE REFER TO MANUFACTURING REPORT #3004209178-2013-03336. FOLLOWING A PUMP IMPLANT AND CATHETER REVISION, THE PATIENT WAS NOTED TO HAVE DEVELOPED AN INFECTION, AND THEIR ENTIRE SYSTEM WAS EXPLANTED.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95726 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention