BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOMED

    MDR report key: 529072 · Received June 7, 2004

    Report

    Report Number
    2182207-2004-00721
    Event Type
    Injury
    Date Received
    June 7, 2004
    Date of Event
    November 6, 2003
    Report Date
    May 20, 2004
    Manufacturer
    NEURO
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED THE PUMP WAS REMOVED BECAUSE THE "PUMP STOPPED FLOWING." THE PUMP WAS NOT REFILLED UNTIL 34 DAYS POST IMPLANT; IT WAS A "DRY PUMP." THE PUP WAS EXPLANTED AND THEN RETURNED TO THE MFR OR ANALYSIS. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFO IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOMED PUMP LKK NEURO 8472 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization CATHETER MODEL 8708 LOT# J11322R17 IMPLANTED: 2003| EXPLANTED: 2003.