BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3894783 · Received June 25, 2014

    Report

    Report Number
    3007566237-2014-01777
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE PAIN PUMP IMPLANTED PRIOR TO 2008 AND IT WAS REMOVED BECAUSE IT WAS INEFFECTIVE. THE PATIENT HAD TO TAKE MORE ORAL MEDICATION. IN ADDITION, WHEN THE DOSE WAS INCREASED IT DID NOT HELP WITH HIS PAIN LEVEL. THE REVISION OCCURRED IN 2009 OR 2010. THE PUMP WAS MOVED BECAUSE IT WAS IN HIS BELT LINE. THE PATIENT STATED THAT ¿MOSTLY MORPHINE¿ WAS IN HIS PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IT WAS FURTHER PROVIDED THAT THE PUMP WAS PUT IN SOMEWHERE AROUND 2008 AND TAKEN OUT IN 2009. THE PUMP HAD NOT WORKED BECAUSE HE WAS ON SO MUCH MEDICATION ORALLY THAT THEY COULD NEVER GET IT TO A POINT WHERE HE WAS GETTING ENOUGH. THE PATIENT WAS TAKING NARCOTICS, OPIOIDS, BENZOS AND ¿SOME OTHER STUFF THAT HE DOESN¿T WANT TO GET INTO.¿ NO SERIAL NUMBER WAS PROVIDED BUT THE PATIENT WAS SURE IT WAS A MEDTRONIC PUMP. THE PUMP WAS REVISED BECAUSE IT WAS SITTING ON HIS BELT LINE AND WAS IRRITATING SO THEY REPOSITIONED IT HIGHER AND TO HIS RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370429 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention