BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET PICOTIP RX

    MDR report key: 1254166 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40735
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET PICOTIP RX IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4055 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other THE DEVICE 0155/200804 WAS IMPLANTED 07-JUL-1999| THE DEVICE 4055/ WAS IMPLANTED| THE DEVICE 4261/243431 WAS IMPLANTED 03-OCT-1996| THE DEVICE 4269/255203 WAS IMPLANTED 03-OCT-1996| THE DEVICE E110/ WAS IMPLANTED| THE DEVICE T125/101042 WAS IMPLANTED 13-JAN-2004