BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 815191 · Received February 8, 2007

    Report

    Report Number
    2124215-2007-19908
    Event Type
    Injury
    Date Received
    February 8, 2007
    Date of Event
    November 26, 2006
    Report Date
    November 26, 2006
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT, IMPEDANCE MEASUREMENTS WITH THIS FLEXTEND VENTRICULAR LEAD HAVE INCREASED FROM 700 OHMS TO 940 OHMS, AND THRESHOLDS HAVE GONE TO OVER5.0/1.0MS AND R WAVES HAVE DECREASED. THE CALLER WAS INQUIRING ABOUT A POSSIBLE PERFORATION. , CALL RESPONSE:, POSSIBLE BUT NO CLINICAL MANIFESTATIONS OF PT ISSUES RELATED TO PERF. CHEST X-RAY TO BE COMPLETED. IMPEDANCES RISE IS SLIGHT SO NOT OVERLY SUSPICIOUS OF FRACTURE, PARTICULARLY SINCE JUST IMPLANTED. SUSPECT POSSIBLE MICRODISLODGE. REP NOTED LIKELY THAT PT WILL HAVE LEAD REPOSITION. !>!G031685-20061126130328!<!,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IS-1 BI POSITIVE FIX IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS 4087 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention