BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOMED

    MDR report key: 1063243 · Received June 19, 2008

    Report

    Report Number
    2182207-2008-03370
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    July 1, 2007
    Report Date
    May 21, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P990034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED DEVICE SYSTEM WAS REMOVED DUE TO INFECTION. NO PT SYMPTOMS OR TREATMENT WERE REPORTED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOMED LKK MEDTRONIC NEUROMODULATION 8472-20-10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER MODEL 8708 LOT# J11635R17