BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 2992119 · Received March 7, 2013

    Report

    Report Number
    3007566237-2013-00706
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUMP WAS NOT WORKING PROPERLY. EITHER INFECTED OR SOMETHING GOES WRONG WITH THE TECHNICAL PART.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS "FOR SOME REASON NOT WORKING PROPERLY," IT WAS "EITHER INFECTED OR SOMETHING WAS WRONG WITH THE TECHNICAL PART" THE HEALTHCARE PROVIDER (HCP) DID NOT KNOW THE WHOLE STORY, BUT THAT THE PATIENT WAS "SUPPOSED" TO BE SCHEDULED FOR "ANOTHER" REFILL BUT THE PUMP WAS NOT WORKING PROPERLY. THE PHYSICIAN "WANTED" AN "ALTERNATIVE" AND "TEMPORARY" WAY TO DELIVER MEDICATION INTRATHECALLY, "NOT GOING THROUGH THE PUMP," WHILE THE PATIENT "WAITED TO GET ANOTHER PUMP OR GET IT FIXED SOMEHOW." IT WAS ALSO NOTED THAT THE PHYSICIAN DID NOT WANT ORAL BACLOFEN. THE HCP THOUGHT THAT THE PATIENT WAS "SUPPOSED" TO HAVE ANOTHER IMPLANT IN A "COUPLE OF WEEKS." THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97148 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other