BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED EL

    MDR report key: 365117 · Received December 7, 2001

    Report

    Report Number
    6000030-2001-00608
    Event Type
    Other
    Date Received
    December 7, 2001
    Date of Event
    January 30, 2001
    Report Date
    October 12, 2001
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED PER ANNUAL DEVICE TRACKING REPORT PT EXPERIENCED "EROSION AND INFECTION OF PUMP" FOLLOW-UP WITH HCP REVEALED THE PRIMARY LOCATION OF THE INFECTION WAS THE DEVICE POCKET. THE DEVICE POCKET CULTURED POSITIVE FOR PSEUDOMONAS AERUGINOSA. THE PT WAS TREATED WITH INTERVENOUS AND ORAL ANTIBIOTICS AND TOTAL DEVICE SYSTEM EXPLANT. THE INFECTION HAS RESOLVED. PT RISKS WAS MALNUTRITION/EXTREMELY THIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55140 SYNCHROMED EL IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization CATHETER MODEL 8703W, LOT# L80502, IMPLANT: 2000| EXPLANT 2001.