BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 3193178 · Received June 27, 2013

    Report

    Report Number
    3007566237-2013-02133
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NO FURTHER INFORMATION WAS AVAILABLE FROM THE HEALTHCARE PROFESSIONAL REGARDING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN THE EMERGENCY ROOM AND WAS ¿JUST ADMITTED TO ONE OF THE SERVICES¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN THE EMERGENCY ROOM (ER) AND WAS ¿CONCERNED ABOUT THE PUMP FUNCTIONS¿ AND WAS ¿SAYING HER PUMP ISN¿T WORKING¿. IT WAS REPORTED THE HEALTH CARE PROVIDER (HCP) IN THE ER WAS ATTEMPTING TO INTERROGATE THE PUMP AND ¿IT SOUNDS LIKE FROM WHAT I CAN GATHER FROM HIS INTERROGATION THAT IT PROBABLY ISN¿T WORKING FINE¿. IT WAS REPORTED AN X-RAY HAD BEEN PERFORMED WHICH SOUNDS THE CATHETER ¿SEEMS TO BE CONGRUITY WITH EVERYTHING. IT LOOKS LIKE IT¿S STILL ATTACHED. IT¿S STILL WHERE IT¿S SUPPOSED TO BE¿. IT WAS NOTED ¿SHORT OF A DYE STUDY¿ OTHERWISE EVERYTHING LOOKED FINE. THE PATIENT HADN¿T HAD ANYTHING DONE TO THE PUMP RECENTLY. THE HCP WAS TRYING TO FIGURE OUT IF THE PATIENT¿S ALLEGATION WAS HER WAY OF SAYING INEFFECTIVE THERAPY HOWEVER, THIS WAS NOT CONFIRMED. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. 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
    293844 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization