BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOMED

    MDR report key: 3011291 · Received March 19, 2013

    Report

    Report Number
    3007566237-2013-00828
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P990034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND NO INTERVENTION WAS PLANNED. THE DRUG DELIVERED VIA THE DEVICE WAS STATED TO BE A PAIN MEDICINE.

    Description of Event or Problem · 1

    IT WAS REPORTED AT A REFILL THE PHYSICIAN THOUGHT TOO MUCH DRUG WAS ASPIRATED WHEN EMPTYING THE RESERVOIR. IN ADDITION, A DYE STUDY WAS PERFORMED IN WHICH APPROXIMATELY 10 CC OF DYE WAS INJECTED. HOWEVER UNDER FLUOROSCOPY, INCLUDING ACTIVE, THE CATHETER APPEARED INTACT BUT IT COULD NOT BE DETERMINED WHERE THE DYE WENT. THERE WAS INQUIRY IF IT HAD GONE BACK INTO THE PUMP. THE MEDICATION DELIVERED THOUGH THIS DEVICE SYSTEM WAS NOT PROVIDED. NO FURTHER DETAILS WERE PROVIDED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113656 ISOMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8472

    Patients

    Seq Age Sex Outcome Treatment
    1