BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE CATHETER

    MDR report key: 4130128 · Received September 30, 2014

    Report

    Report Number
    3007566237-2014-02784
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) HAD ¿SOME TROUBLE GETTING THE DRUG IN¿ DURING HIS PAIN PUMP TRIAL. IT WAS LATER FURTHER SPECIFIED AS TROUBLE GETTING DRUG INTO THE PATIENT¿S SPINE. THE DRUG TRIAL WAS NOT SUCCESSFUL. THE HCP USED PRIALT. NO PATIENT SYMPTOMS WERE REPORTED. TROUBLESHOOTING AND EVENT RESOLUTION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607160 UNKNOWN IMPLANTABLE CATHETER PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_CATH

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR