BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 3231776 · Received July 17, 2013

    Report

    Report Number
    3007566237-2013-02376
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ¿WE HAD AN INFECTION HE DID IN SURGERY A YEAR AGO¿. IT WAS REPORTED THE HEALTH CARE PROVIDER HAD REFERRED THE PATIENT TO THE SURGEON FOR A BACLOFEN PUMP REPLACEMENT IN A TIMELY MANNER AND THE PATIENT WENT AND HAD THE PUMP REPLACED. MEANWHILE A WEEK LATER THE PATIENT GOT AN INFECTION AND ENDED UP BACK IN THE HOSPITAL. IT WAS REPORTED THE SURGEON HAD SAID TO THE HEALTH CARE PROVIDER (HCP) ¿I¿M GOING TO TAKE THIS PUMP OUT. IT¿S REALLY INFECTED. I GOT TO GET HIS PUMP OUT¿. THE HCP THEN SAID ¿THEY¿RE GOING TO WITHDRAW. YOU¿RE ON A BIG DOSE¿. THE HCP THEN HAD PUT THE PATIENT IN THE INTENSIVE CARE UNIT AND CUT THE PATIENT¿S DOSE DOWN BY 40 PERCENT A DAY. THE HCP ¿WATCHED¿ THE INFECTION AND DID A REPLACEMENT AS SOON AS IT WAS SAFE. IT WAS NOTED THE HCP HADN¿T HAD A CHANCE TO SEE THE PATIENT FOR FOLLOW UP ¿BECAUSE HE HAD JUST THE SURGERY AND WE WEREN¿T GOING TO DO ANOTHER FOR A MONTH¿. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332619 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R