BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-POINT-FOR

    MDR report key: 354119 · Received October 1, 2001

    Report

    Report Number
    2182207-2001-00308
    Event Type
    Other
    Date Received
    October 1, 2001
    Date of Event
    January 14, 2000
    Report Date
    December 18, 2000
    Manufacturer
    MEDTRONIC INC..
    Product Code
    GZF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT OF EXPLANT OF DEVICE DUE TO "TIBIAL LEAD REMOVED DUE TO INFECTION" RECEIVED PER ANNUAL DEVICE TRACKING REPORT. FOLLOW UP WITH HCP REVEALED "THIS INFECTION OCCURRED LONG (>3 YEARS) AFTER IMPLANTATION. THE INFECTION WAS CAUSED BY THE PT'S ANCHOR AND WIRE CREATING A SUBCUTANEOUS PROMINENCE THAT LED TO AN ULCER." THE PT EVENTUALLY RETURNED WITH AN INFECTION WITH EXPLANT IN 2000. (DEVICE TRACKING REPORT AND FOLLOW UP REPORT DIFFER ON EXACT DATE.) THE SYMPTOMS INCLUDED FEVER, REDNESS, SWELLING, AND DRAINAGE. THE PRIMARY LOCATION OF THE INFECTION WAS THE LEAD TRACK. A CULTURE OF THE LEAD WAS OBTAINED AND WAS POSITIVE FOR STAPH. THE PT WAS TREATED WITH IV ANTIBIOTICS AND EXPLANT OF THE LEAD. THE INFECTION RESOLVED AND A REPLACEMENT IS PLANNED FOR THE SUMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44275 ON-POINT-FOR LEAD GZF MEDTRONIC INC.. 3987 NBC001343N

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization