BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3203132 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01140
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    September 11, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MOTOR STALL. ¿THEY¿ WEREN¿T ABLE TO RESET IT TO KEEP IT GOING. NO FURTHER INFORMATION WAS REPORTED AT THE TIME OF THIS REPORT. THE PATIENT OUTCOME WAS UNKNOWN. THE DEVICE SYSTEM WAS USED TO DELIVER AN UNKNOWN DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302710 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention