BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1002288 · Received February 22, 2008

    Report

    Report Number
    2182207-2008-00883
    Event Type
    Injury
    Date Received
    February 22, 2008
    Report Date
    January 11, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HCP HAD A PT WITH AN INFECTED PUMP. NO OTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR IMPLANTED| EXPLANTED| CATHETER MODEL CATHETER LOT# UNK| IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED