BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3171021 · Received June 14, 2013

    Report

    Report Number
    3007566237-2013-01990
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR YEARS AGO SOMEBODY HAD MISSED A PATIENT¿S ELECTIVE REPLACEMENT INDICATOR (ERI) AND THEN MISSED THE PATIENT¿S END OF SERVICE (EOS). IT WAS NOT KNOWN WHAT MEDICATION THE DEVICE SYSTEM DELIVERED. FURTHER ATTEMPTS WERE MADE TO CLARIFY THE EVENT AND PATIENT, HOWEVER, NO FURTHER DETAILS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271452 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1