BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 784347 · Received November 9, 2006

    Report

    Report Number
    2124215-2006-18208
    Event Type
    Injury
    Date Received
    November 9, 2006
    Date of Event
    September 13, 2006
    Report Date
    September 14, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE, THE 4087/263162 LEAD WAS ATTEMPTED AND REMOVED DUE TO PLACEMENT DIFFICULTY AFTER TWELVE ATTEMPTS TO POSTITION IN THE ATRIUM. THE 4086/235749 LEAD WAS ALSO ATTEMPTED IN THE ATRIUM, AND REMOVED DUE TO PATIENT CONDITION. LATER, AT ONE DAY POST-IMPLANT, THE 4087/262407 ATRIAL LEAD EXHIBITED SUB-OPTIMAL SENSING AND THE 4088/222987 RIGHT VENTRICULAR LEAD HAD DISLODGED. IN A REVISION PROCEDURE, THE 4088/222987 RIGHT VENTRICULAR LEAD COULD NOT BE REPOSITIONED DUE TO A STUCK HELIX, AND WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IS-1 BI POSITIVE FIX IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4088 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention