BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TINED LEAD

    MDR report key: 920887 · Received September 21, 2007

    Report

    Report Number
    6000153-2007-03062
    Event Type
    Injury
    Date Received
    September 21, 2007
    Report Date
    April 10, 2006
    Manufacturer
    MPROC VILLALBA
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED WHICH COVERS A 2-YEAR RETROSPECTIVE REVIEW OF EVENTS REPORTED BY CONSUMERS BETWEEN JANUARY 1, 2005 AND DECEMBER 31, 2006 (INCLUSIVE). THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY, DEATH AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 3 UNREPORTED SERIOUS INJURY EVENTS FOR MODEL LEAD, 1 SERIOUS INJURY EVENT FOR MODEL 3889 FOR THE ABOVE TIME PERIOD (PRODUCT CODE EZW). (SEE THE ATTACHED SUMMARY REPORT FOR A LISTING OF THE EVENT.)

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD ERODED FROM THE SKIN AND NEEDED TO BE REVISED. THE PATIENT UNDERWENT A REVISION AND THE AREA OF THE LEAD WAS RED AND THERE WAS A LIKELIHOOD OF ADDITIONAL EROSION, SO THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TINED LEAD EZW MPROC VILLALBA 3889 V000070

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention EXPLANTED| IMPLANTABLE PULSE GENERATOR MODEL 3023 | LOT # NBV126249H| EXPLANTED| LOT # NBV126249H| IMPLANTABLE PULSE GENERATOR MODEL 3023