BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR STEROID ELUTING LEAD

    MDR report key: 95910 · Received May 8, 1997

    Report

    Report Number
    2124215-1997-01613
    Event Type
    Injury
    Date Received
    May 8, 1997
    Date of Event
    January 3, 1997
    Report Date
    January 22, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS BIPOLAR LEAD WAS REPOSTIONED. THREE DAYS AFTER THE IMPLANT THE LEAD BECAME DISLODGED. THE PHYSICIAN ELECTED TO REPOSITON THE LEAD. * THE PHYSICIAN'S MANUAL 352527-003C, PAGE 15, LISTS DISPLACEMENT AS AN ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR STEROID ELUTING LEAD Implant BIPOLAR LEAD DTB CARDIAC PACEMAKERS 4285 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention THE DEVICE 4269/264532 WAS IMPLANTED 03-JAN-1997