BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 3981371 · Received August 5, 2014

    Report

    Report Number
    3007566237-2014-02185
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 14, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WOULD DO ANYTHING TO HAVE HIS PAIN PUMP BACK IN BUT IT ¿HASN¿T BEEN RIGHT¿ SINCE HIS ORIGINAL HEALTH CARE PROVIDER (HCP). IT WAS ALSO REPORTED THAT EVEN WHEN THE PATIENT¿S NEW HEALTH CARE PROVIDER (HCP) FILLED THE PUMP, ¿SOMETHING WASN¿T RIGHT NO MATTER WHAT¿ AND IT WAS REPORTED THE PATIENT HURT ¿ALL THE TIME¿. THE PAIN PUMP WASN¿T DOING WAS IT WAS SUPPOSED TO DO. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM AT THE TIME OF THE EVENT WAS NOT PROVIDED HOWEVER HYDROMORPHONE WAS LISTED AS AN OLD MEDICATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458298 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR