BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED EL

    MDR report key: 363932 · Received November 30, 2001

    Report

    Report Number
    6000030-2001-00511
    Event Type
    Other
    Date Received
    November 30, 2001
    Date of Event
    July 31, 2001
    Report Date
    September 17, 2001
    Manufacturer
    METRONIC INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT OF EXPLANT OF DEVICE DUE TO "WOUND DEHISCENCE - INFECTION - ORGANISM - GRAMS AND RODS" RECEIVED PER DEVICE RETURNED PRODUCT REPORT. REPEATED REQUESTS FOR ADDITIONAL INFORMATION ABOUT THIS EVENT HAVE BEEN UNANSWERED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54028 SYNCHROMED EL IMPLANTABLE INFUSION PUMP LKK METRONIC INC. 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization CATHETER MODEL 8709, L0T# J0056584R, IMPLANT 2000,| EXPLANT 2001.