BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 609206 · Received May 7, 2004

    Report

    Report Number
    2124215-2004-07183
    Event Type
    Malfunction
    Date Received
    May 7, 2004
    Date of Event
    January 12, 2004
    Report Date
    January 29, 2004
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE LEAD (S/N 151220) BECAME DISLODGED FROM THE PATIENT'S VENTRICLE AFTER 8 MONTHS IN SERVICE. THE PHYSICIAN EXPERIENCED DIFFICULTY DURING THE PROCEDURE TO REPLACE THIS LEAD; THE HELIX MECHANISM OF THE REPLACEMENT LEAD (S/N 201789) EXTENDED, BUT WOULD NOT RETRACT.

    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 74 YR Other