BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3203488 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00964
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    July 23, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HCP THERE WAS A PUMP THAT SHUT OFF A MONTH SOONER THAN ITS REPLACE BY DATE. ON A FOLLOW UP COMMUNICATION THE HCP SAID SHE COULD NOT RECALL A PATIENT NAME OR THAT SHE SAID SHE KNEW ABOUT A PATIENT WHOSE PUMP SHUT OFF A MOTH BEFORE ERI. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302299 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1