BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UKNOWN IMPLANTABLE INFUSION CATHETER

    MDR report key: 3202364 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00282
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    February 29, 2012
    Report Date
    March 6, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION SULLIVAN LAKE
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THERAPY TRIAL THE PATIENT FELT LIKE SHE WAS HAVING ¿A REALLY BIG DRUG OVERDOSE.¿ IT WAS NOTED THAT EVERYTHING WENT REALLY WELL FOR THE FIRST COUPLE OF DAYS. SHE STARTED ON WEDNESDAY. ON THURSDAY, THE PATIENT WENT IN AND HAD THE DRUG INCREASED BY ¿0.1.¿ BY FRIDAY, THE PATIENT¿S FAMILY HAD A GREAT DEAL OF DIFFICULTY GETTING THE PATIENT AWAKE, AND HAD TO WAKE THE PATIENT UP EVERY HOUR FOR ABOUT 24 HOURS. THE PATIENT FELT LIKE SHE HAD ¿TOO MUCH DRUG IN HER SYSTEM.¿ IT WAS NOTED THAT THE PATIENT WAS ON A ¿VERY MINUTE AMOUNT¿ OF HYDROMORPHONE (DILAUDID).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300923 UKNOWN IMPLANTABLE INFUSION CATHETER PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION SULLIVAN LAKE NEU_UNKNOWN_CATH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other